Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Preemption and the Federal Food, Drug, and

Cosmetic Act (FD&C Act)

Updated May 8, 2026

Congressional Research Service

https://crsreports.congress.gov

R48915

SUMMARY

Preemption and the Federal Food, Drug, and

Cosmetic Act (FD&C Act)

R48915

May 8, 2026

Wen W. Shen

Legislative Attorney

First enacted in 1938, the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended,

empowers the Food and Drug Administration (FDA) to regulate various products affecting public

health, including food, drugs, medical devices, cosmetics, and tobacco products. By FDA’s

Dorothy C. Kafka

estimate, the products it oversees in 2025 were valued at $4.1 trillion and accounted for about 21

Legislative Attorney

cents of every dollar spent by U.S. consumers. In general, the FD&C Act prohibits the

distribution of a covered product in interstate commerce that is “adulterated” or “misbranded,”

and defines, for each product type, the circumstances and standards under which that product is

“adulterated” or “misbranded.” Additional statutory or regulatory provisions often further refine

the specific federal requirements that apply to specific subsets or components of a product type. Some subsets of drugs,

devices, and tobacco products, for instance, must be reviewed by FDA before they can be lawfully marketed, while food and

cosmetic products (with the exception of certain ingredients) generally are not subject to premarket review.

States have historically regulated many products covered by the FD&C Act based on their general police power to provide

for the public health and safety of their residents. State regulation of such products might include statutes specific to certain

products, along with more general consumer protection and products liability laws. State consumer protection and products

liability laws provide mechanisms by which consumers allegedly injured by a relevant product may challenge the product’s

promotion, manufacture, design, and/or warning, on the grounds that the defendant manufacturers should have taken a

different course of action with respect to those activities—some of which may be regulated by the FD&C Act and its

implementing regulations.

Under the U.S. Constitution’s Supremacy Clause, federal law supersedes (preempts) conflicting state law and can do so

expressly—through explicit preemption provisions specifying the scope of preempted state law—or impliedly—where a state

law is displaced because it conflicts with federal law or because federal law so thoroughly occupies the regulatory field as to

leave no room for state activity. Over the FD&C Act’s nearly 90-year history, Congress has amended the law to include

provisions that expressly preempt certain state laws that address areas specifically regulated by the FD&C Act, such as state

laws imposing requirements on the safety and efficacy of medical devices, labeling requirements for food and cosmetic

products, and requirements on certain standards for tobacco products. In other instances, Congress has not spoken

specifically to preemption, as is the case for FD&C Act provisions governing prescription drugs.

Courts—including the Supreme Court—have frequently considered the preemptive scope of the FD&C Act on state statutes

and causes of action—an inquiry the Court has sometimes described as focused on discerning the intent of Congress. In

practice, courts often look to the text, structure, and contextual background of the relevant FD&C Act provisions to

determine their preemptive scope. This report provides an overview of the courts’ FD&C Act preemption jurisprudence,

focusing on the following FDA-regulated products: food products, prescription drugs, medical devices, cosmetics, and

tobacco products. Generally speaking, these cases illustrate that while the FD&C Act’s enforcement scheme impliedly

preempts a particular type of state fraud claim (i.e., one alleging that an applicant made misrepresentations to FDA during a

premarket review process), context-specific analyses are usually required to assess whether other state laws or claims are

preempted. In these analyses, courts typically undertake a case-specific, often granular, comparative analysis of what an

applicable federal law requires or permits and whether and to what extent the relevant state requirements conflict with federal

requirements. The courts’ nuanced approach often results in the preservation of at least some state claims or requirements—a

result that arguably reflects the courts’ recognition of states’ long-standing, concurrent role in the regulation of these

products. State requirements are most likely to survive preemption where Congress is silent on the interaction of federal and

state law, but courts have sometimes understood the FD&C Act’s express preemption provisions as leaving room for certain

state requirements. At the same time, courts may be more likely to construe relevant FD&C Act provisions to have broader

preemptive effect on certain aspects of product regulation that are not historically regulated by states. These considerations

may inform Congress’s decision on whether to modify existing express preemption provisions, add additional express

preemption provisions, and consider the appropriate degree of specificity of any such provisions.

Congressional Research Service

Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Contents

Background on Federal Preemption ................................................................................................ 3

Preemption and the FD&C Act........................................................................................................ 6

Preemption Based on the FD&C Act’s Enforcement Scheme .................................................. 7

Preemption Based on FD&C Act’s Product-Specific Provisions .............................................. 9

Food Products ....................................................................................................................11

Prescription Drugs ............................................................................................................ 19

Medical Devices ............................................................................................................... 26

Cosmetics .......................................................................................................................... 33

Tobacco Products .............................................................................................................. 36

Observations and Considerations for Congress ............................................................................. 43

Contacts

Author Information........................................................................................................................ 45

Congressional Research Service

Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

U

nder the United States’ federalist system, the federal government and states share

regulatory authority over public health matters, with states traditionally exercising the

bulk of the authority pursuant to their general police power.1 This inherent power enables

states, within constitutional limits, to enact laws “to provide for the public health, safety, and

morals” of the states’ inhabitants.2 At the same time, the federal government shares certain

concurrent authority in this area emanating from its enumerated powers in the Constitution.3 The

regulation of products implicating public health—including food, drugs, biologics, medical

devices, cosmetics, and tobacco products—reflects this overlapping authority.

Since 1906, Congress has enacted laws regulating products affecting public health, relying on its

authority under the Commerce Clause to regulate persons or things in or affecting interstate

commerce.4 The Pure Food and Drug Act of 1906 prohibited the sale of misbranded or

adulterated food and drugs in interstate commerce.5 In 1938, Congress replaced that law with the

Federal Food, Drug, and Cosmetic Act (FD&C Act, or the Act).6 As amended over the years, the

FD&C Act provides the federal legal framework governing the regulation of food, drugs,

cosmetics, medical devices, tobacco, and other products. By the Food and Drug Administration’s

(FDA’s) own estimate, the products it oversees in 2025 were valued at $4.1 trillion and accounted

for about 21 cents of every dollar spent by U.S. consumers.7

Under its general framework, the FD&C Act prohibits the distribution of a covered product in

interstate commerce that is “adulterated” or “misbranded.”8 The Act then defines, for each

product type, the circumstances and standards under which that product is “adulterated” or

misbranded.”9 Some regulated products are required to be reviewed by FDA before they can be

lawfully marketed while other products are not. The 1938 law, for example, transformed the

regulation of new drugs from a regime that removed harmful drugs off the market after the fact,

to a regime that mandates premarket approval of new drugs—that is, a regime under which

manufacturers of new drugs must demonstrate the products’ safety before they can be sold on the

market.10 Over time, that premarket approval regime expanded to include a determination of

1 See Jacobson v. Massachusetts, 197 U.S. 11, 25, 39 (1905) (upholding a state law authorizing local public health

officials to require vaccination against smallpox, observing that “[a]lthough this court has refrained [] from any attempt

to define the limits of [states’ police] power, . . . it has distinctly recognized the authority of a State to enact quarantine

laws and ‘health laws of every description’” (quoting Gibbons v. Ogden, 22 U.S. (9 Wheat.) 1, 203 (1824)); see also

Elizabeth Y. McCuskey, Body of Preemption: Health Law Traditions and the Presumption Against Preemption, 89

TEMPLE L. REV. 95, 113–20 (2016) (providing an overview of state and federal authorities in the regulation of health

matters).

2 Barnes v. Glen Theatre, Inc., 501 U.S. 560, 569 (1991).

3 See CRS Report R45323, Federalism-Based Limitations on Congressional Power: An Overview, coordinated by

Kevin J. Hickey, at 1 (2023).

4 See generally LIBR. OF CONG., Persons or Things in and Instrumentalities of Interstate Commerce, CONSTITUTION

ANNOTATED, https://constitution.congress.gov/browse/essay/artI-S8-C3-6-3/ALDE_00013420/ (last visited Mar. 30,

2026) (providing overview of the Supreme Court’s Commerce Clause jurisprudence); LIBR. OF CONG., Intrastate

Activities Having a Substantial Relation to Interstate Commerce, CONSTITUTION ANNOTATED,

https://constitution.congress.gov/browse/essay/artI-S8-C3-6-4/ALDE_00013421/(last visited Mar. 30, 2026) (same).

5 Ch. 3915, 34 Stat. 768 (1906).

6 Ch. 675, 52 Stat. 1040 (1938) (codified as amended at 21 U.S.C. §§ 331–399i).

7 OFF. OF THE COMM’R, U.S. FOOD & DRUG ADMIN., FDA AT A GLANCE (2026),

https://www.fda.gov/media/154548/download [https://perma.cc/TY9H-JKGK].

8

See 21 U.S.C. § 331.

9 See, e.g., id. §§ 342–343, 351–352, 361–362, 387b–387c.

10 See ch. 675, § 505, 52 Stat. at 1052.

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

efficacy in addition to safety.11 Congress also applied the premarket review framework—with

different product-specific standards—to the regulation of other products, including certain

medical devices12 and tobacco products.13 Other products, such as food and cosmetic products,

are generally (with the exception of certain ingredients)14 not subject to premarket review but are

subject to other federal requirements.15

Meanwhile, states maintain a role in the regulation of these products, often through a diverse set

of laws that reflect the piecemeal approach to regulation that began in the 1800s.16 For instance,

while a majority of states have adopted the Uniform State Food, Drug, and Cosmetic Act based

on the 1938 FD&C Act, significant variations remain among the food and drug laws of the

different states because not all states have adopted all parts of the Uniform Act or incorporated all

amendments to the federal FD&C Act.17

In addition to state statutes that specifically address products regulated by the FD&C Act, states

have also enacted general consumer protection statutes that prohibit, to varying degrees,

deceptive or unfair business practices.18 These state consumer protection laws provide a

mechanism for consumers allegedly harmed by a relevant product to seek redress for such harm if

it stems from a prohibited practice.19

Finally, state tort law—developed through judicial decisions—applies to FD&C Act-regulated

products.20 State tort law, and in particular, products liability law, provides an avenue for

individuals harmed by a product to assert claims challenging the manufacture, design, or warning

of the product.21

The interaction between these sometimes overlapping federal and state laws implicates the

preemption doctrine. Under the Constitution’s Supremacy Clause,22 federal law supersedes

(preempts) conflicting state laws.23 The Supreme Court has identified two general types of

11 See Drug Amendments of 1962, Pub. L. No. 87-781, § 102, 76 Stat. 780, 781 (codified as amended at 21 U.S.C.

§§ 321, 355).

12 See Medical Device Amendments of 1976, Pub. L. No. 94-295, § 2, sec. 513(a)(1)(C), 90 Stat. 539, 541 (codified as

amended at 21 U.S.C. § 360e).

13 See Family Smoking Prevention and Tobacco Control Act of 2009, Pub. L. No. 111-31, § 101(b)(3), sec. 910, 123

Stat. 1176, 1807 (codified as amended at 21 U.S.C. § 387j).

14 See, e.g., 21 U.S.C. §§ 348, 379e.

15 See, e.g., id. §§ 341, 342–343, 361–362, 364a–364e.

16 See Peter Barton Hutt, et al., FOOD & DRUG LAW 424–25 (5th ed. 2022).

17 See id. at 425–26.

18 All 50 states have enacted general consumer protection statutes—sometimes referred to as Unfair and Deceptive Acts

and Practices (UDAP) laws—that prohibit deceptive and/or unfair business practices. The specific scope of prohibited

conduct and the entities subject to the prohibition vary among states. See NAT’L CONSUMER L. CTR., CONSUMER

PROTECTION IN THE STATES: A 50-STATE EVALUATION OF UNFAIR AND DECEPTIVE PRACTICES LAWS 1–3 (2018),

https://www.nclc.org/wp-content/uploads/2022/09/UDAP_rpt.pdf [https://perma.cc/2FW6-9D8Q].

19 See id.

20 State tort law originates in common law and provides a mechanism, through case-by-case litigation, for a person

injured by the wrongful or injurious actions of another to recover damages. Products liability is a subset of tort law that

permits a plaintiff injured by a defective product to recover damages from the manufacturer of that product. For more

background information on state tort law, see CRS In Focus IF11291, Introduction to Tort Law, by Andreas Kuersten

(2023).

21 See RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 2 (A.L.I. 1998).

22 U.S. CONST., art. VI, Cl. 2.

23 See Murphy v. Nat’l Collegiate Athletic Ass’n, 584 U.S. 453, 471 (2018); Gade v. Nat’l Solid Wastes Mgmt. Ass’n,

505 U.S. 88, 108 (1992).

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

preemption: express and implied preemption. Federal law expressly preempts state laws when a

federal statute or regulation contains explicit preemptive language.24 Even when Congress is

silent on a federal statute’s preemptive effect, a state requirement can be impliedly preempted

where it conflicts with federal law or where federal law so thoroughly occupies the regulatory

field as to leave no room for state regulation.25

The FD&C Act implicates both express and implied preemption. Over the years, Congress has

amended the Act to expressly preempt certain regulated products or topics, but sometimes there is

uncertainty regarding these provisions’ scope.26 In other instances, Congress has not spoken

directly to the preemptive effect of the FD&C Act’s regulation of a particular matter, leaving it to

courts, in disputed cases, to determine when or whether a state requirement is impliedly

preempted.27 Both express and implied preemption questions can arise when states regulate

products or issues addressed directly by the FD&C Act, or when state law provides a cause of

action (e.g., through products liability or consumer protection laws) for injuries allegedly caused

by an FDA-regulated product.28

This report provides an overview of the courts’ FD&C Act preemption jurisprudence, focusing on

certain FDA-regulated products. It begins with an overview of the preemption doctrine, and then

examines the doctrine as applied to the FD&C Act’s general enforcement scheme as well as to the

Act’s product-specific regulatory schemes for the following categories of FDA-regulated

products: (1) food products; (2) prescription drugs; (3) medical devices; (4) cosmetics; and

(5) tobacco products.29 For each product type, the discussion first highlights the relevant FD&C

Act provisions, including any express preemption provisions, and then analyzes how courts have

interpreted those provisions to determine their preemptive scope. The report concludes with

selected observations and considerations for Congress.

Background on Federal Preemption

The U.S. Constitution’s Supremacy Clause provides that “the Laws of the United States . . . shall

be the supreme Law of the Land” notwithstanding “the Constitution or Laws of any State to the

Contrary.”30 As interpreted by the Supreme Court, this Clause forms the basis of the federal

preemption doctrine, under which federal law supersedes state laws if state laws “interfere with,

or are contrary to federal law.”31 In describing the inquiry into whether—and to what extent—a

federal law preempts state law, the Court has at times said that discerning congressional intent is

24 Murphy, 584 U.S. at 478.

25 Id. at 478-80.

26 See, e.g., infra “Case Law on the Preemptive Scope of FD&C Act Section 521 on State Tort Law Claims.”

27 See infra “Case Law on the Preemptive Scope of Selected Prescription Drug Provisions.”

28 See, e.g., infra “Case Law on the Preemptive Scope of FD&C Act Section 521 on State Tort Law Claims.”

29 Other products subject to FDA regulation include other subcategories of food and drug products—such as dietary

supplements (which are a subset of “food” under the FD&C Act), over-the-counter drugs, and animal drugs—as well as

biological products. See 21 U.S.C. §§ 343(s), 355h, 360b; 42 U.S.C. § 262. Biological products, or biologics, are a

diverse category of products (including vaccines and blood products) used to diagnose, prevent, and treat diseases and

conditions; they are made from living organisms and are generally large, complex molecules. See 42 U.S.C.

§ 264(i)(1); see also CRS Report R44620, Biologics and Biosimilars: Background and Key Issues, by Hassan Z. Sheikh

(2019). Unlike other FDA-regulated products, biological products are subject to the Public Health Service Act (PHSA)

rather than the FD&C Act, but the relevant PHSA provisions incorporate by reference many FD&C Act provisions that

apply to prescription drugs. See, e.g., 42 U.S.C. §§ 262(a)(2)(B); 262(a)(2)(D); 262(h); 262(j). A discussion of the

preemption jurisprudence pertaining to these other products is beyond the scope of this report.

30 U.S. CONST. art. VI, cl. 2.

31 Hillsborough Cnty. v. Automated Med. Labs, 471 U.S. 707, 712 (1985).

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the “ultimate touchstone” in the analysis.32 In practice, the Court has, to varying degrees,

considered the text, structure, purpose, and contextual background of a federal statute when

considering its preemptive effect.33

Federal law can preempt state law either expressly or impliedly. Express preemption occurs when

a state law is displaced by explicit preemptive language—often called an express preemption

provision—contained in a federal statute or regulation.34 In those instances, determining the scope

of the preemption clause is largely a matter of statutory construction.35 The Supreme Court has

instructed that Congress’s intent with respect to express preemption is discerned “primarily” from

a statute’s text, but the Court has also often looked to the larger context and purpose of the

particular statutory scheme, particularly in the context of discerning the preemptive scope of the

FD&C Act.36

Even where a federal law’s express preemption provision does not preempt a state law or where a

federal law lacks an express preemption provision altogether, the federal law can still impliedly

preempt state law when Congress’s preemptive intent is implicit in the relevant federal law’s

structure and purpose.37 The Supreme Court has identified two types of implied preemption: field

preemption and conflict preemption.38 Field preemption occurs when Congress has evidenced a

desire to occupy the entire field of regulation, such that there is “no room for the states to

supplement it.”39 Given states’ traditional role in regulating the products subject to the FD&C

32 Wyeth v. Levine, 555 U.S. 555, 565 (2009) (quoting Medtronic, Inc. v. Lohr, 518 U.S. 470, 485 (1996)). See also

Hughes v. Talen Energy Mktg., LLC, 578 U.S. 150, 162–63 (2016) (stating the same).

33 See, e.g., Wyeth v. Levine, 555 U.S. 555, 565-66 (2009) (considering the history of federal regulation of drugs and

drug labeling when deciding whether a state measure was impliedly preempted by federal law); Va. Uranium, Inc. v.

Warren, 587 U.S. 761, 767 (2019) (Gorsuch, J., lead opinion) (describing the Court’s preemption analysis as “guided

by the traditional tools of statutory interpretation”); id. at 785–87,791–93 (Kagan, J., concurring in judgment) (stating

that “‘the purpose of Congress is the ultimate touchstone’ in determining whether federal law preempts state law,” and

focusing on the relevant text of the Atomic Energy Act and the law’s purposes to determine its preemptive scope

(quoting Hughes, 578 U.S. at 162–63)); Kansas v. Garcia, 589 U.S. 191, 208 (2020) (stating that the respondents’

argument concerning implied preemption, “like all preemption arguments, must be grounded ‘in the text and structure

of the statute at issue’” (quoting CSX Transp., Inc. v. Easterwood, 507 U.S. 658, 664 (1993)); id. at 215 (Kagan, J.,

concurring in part) (analyzing whether a state law was impliedly preempted by a federal law by considering the federal

law’s “text, together with its structure, context, and purpose”).

34 See, e.g., Riegel v. Medtronic, 552 U.S. 312, 330 (2008) (analyzing the scope of Medical Device Amendments’

express preemption provision, which preempts state requirements that are “‘different from, or in addition to’ the

requirements imposed by federal law” (quoting 21 U.S.C. § 360k(a)(1)). For more information about federal

preemption, see CRS Report R45825, Federal Preemption: A Legal Primer, by Bryan L. Adkins, Alexander H. Pepper,

and Jay B. Sykes (2023).

35 See Cent. Maine Power Co. v. Maine Comm’n on Governmental Ethics & Election Pracs., 144 F.4th 9, 31 (1st Cir.

2025) (regarding a question about whether the Federal Election Campaign Act expressly preempted a state law

prohibiting political campaign spending by certain “foreign government-influenced entity, observing that “issues of

federal preemption are questions of statutory interpretation”); Adkins, Pepper & Sykes, supra note 34, at 3–4. See

generally CRS Report R45153, Statutory Interpretation: Theories, Tools, and Trends, by Valerie C. Brannon (2023).

36 See, e.g., Medtronic, Inc. v. Lohr, 518 U.S. 470, 486 (1996) (explaining that relevant to the analysis of an express

preemption provision is the “‘structure and purpose of the statute as a whole,’ as revealed not only in the text, but

through the reviewing court’s reasoned understanding of the way in which Congress intended the statute and its

surrounding regulatory scheme to affect business, consumers, and the law” (citation omitted) (quoting Gade v. Nat’l

Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 98 (1992)).

37 The Supreme Court has stated on several occasions that “the existence of a separate pre-emption provision does not

bar the ordinary working of conflict pre-emption principles.” Hillman v. Maretta, 569 U.S. 483, 498 (2013) (internal

quotations omitted); see also Arizona v. United States, 567 U.S. 387, 406 (2012) (similar).

38 See Adkins, Pepper & Sykes, supra note 34, at 17.

39 City of Charleston v. A Fisherman's Best, Inc., 310 F.3d 155, 169 (4th Cir. 2002).

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Act, courts have often declined to apply field preemption in areas covered by the Act.40 However,

in certain discrete contexts—such as drug importation—some courts have concluded that the

relevant FD&C Act provisions evidenced an intent by Congress to occupy the regulatory field.41

The other type of implied preemption is the doctrine of conflict preemption, for which the

Supreme Court has recognized two subcategories: impossibility preemption and obstacle

preemption.42 Impossibility preemption can occur when it is “impossible for a private party to

comply with both state and federal requirements.”43 In addition to considering the relevant

statutory text, context, and history, courts analyzing impossibility preemption tend to focus on a

comparative analysis of the specific implementation of the federal law versus relevant state law.44

The Supreme Court has seldom invoked impossibility preemption45 and has described it as a

“demanding defense” when used to defeat the effect of a state law.46 At the same time, the Court

has twice relied on the doctrine to hold that federal labeling requirements for generic drugs

preempt state law claims that would require generic drug manufacturers to provide different or

additional warnings in the drugs’ labeling.47

Obstacle preemption can occur if the implementation of state law “stands as an obstacle to the

accomplishment and execution of the full purposes and objectives of Congress.”48 The Supreme

Court has said that “[w]hat is a sufficient obstacle [for purposes of obstacle preemption] is a

matter of judgment to be informed by examining the federal statute as a whole and identifying its

purpose and intended effects.”49 While obstacle preemption has played an important role in the

Court’s preemption jurisprudence since the mid-20th century, and has been invoked by the Court

in the FD&C Act context to preempt certain state-law claims,50 some Justices have called the

doctrine into question. In particular, they criticize the doctrine for “invalidat[ing] state laws based

on perceived conflicts with broad federal policy objectives, legislative history, or generalized

notions of congressional purposes that are not embodied within the text of federal law.”51

40 See, e.g., Lefaivre v. KV Pharm. Co., 636 F.3d 935, 941 (8th Cir. 2010) (concluding that the federal scheme of drug

regulation “is not ‘so pervasive in scope that it occupies the field.’” (quoting In re Aurora Dairy Corp. Organic Milk

Mktg. & Sales Pracs. Litig., 621 F.3d 781, 792 (8th Cir. 2010))).

41 See infra notes 246-251 and accompanying text.

42 See Adkins, Pepper & Sykes, supra note 34, at 23; Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 480 (2013); Gade v.

Nat’l Solid Wastes Mgmt. Ass’n, 505 U.S. 88, 98 (1992).

43 Bartlett, 570 U.S. at 480.

44 See infra notes 229–235 and accompanying text.

45 See Adkins, Pepper & Sykes, supra note 34, at 24 (noting that the Court’s case law on impossibility preemption “is

not as well developed as other areas of its preemption jurisprudence”).

46 Wyeth v. Levine, 555 U.S. 555, 573 (2009).

47 See id.

48 Gade, 505 U.S. at 98; see also Lamps Plus, Inc. v. Varela, 587 U.S. 176, 183 (2019) (similar).

49 Crosby v. Nat’l Foreign Trade Council, 530 U.S. 363, 373 (2000).

50 See infra “Preemption Based on the FD&C Act’s Enforcement Scheme.”

51 Levine, 555 U.S. at 583 (Thomas, J., concurring in the judgment); see also Kansas v. Garcia, 589 U.S. 191, 213

(2020) (Thomas, J., concurring) (similar); Va. Uranium, Inc. v. Warren, 587 U.S. 761, 778 (2019) (Gorsuch, J., lead

opinion) (“[I]n piling inference upon inference about hidden legislative wishes we risk displacing the legislative

compromises actually reflected in the statutory text . . . . [, and i]n disregarding these legislative compromises, we may

only wind up displacing perfectly legitimate state laws on the strength of ‘purposes’ that only we can see, that may

seem perfectly logical to us, but that lack the democratic provenance the Constitution demands before a federal law

may be declared supreme.”).

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An area of potential uncertainty is whether and under what circumstances should a canon of

statutory construction known as “presumption against preemption” apply.52 This canon, rooted in

principles of federalism and respect for state sovereignty, generally instructs that courts should

not construe a federal law to preempt a state law implicating the state’s historic police powers

“unless that was the clear and manifest purpose of Congress.”53 In preemption cases, the Supreme

Court has at times applied this canon and described it as one of the “cornerstones” of its

preemption jurisprudence.54 Other times, however, the Court has resolved preemption questions

without referencing the canon.55 The Court’s FD&C Act preemption cases reflect this

inconsistency.56 As discussed further below, the Court has, for instance, relied on the canon to

hold that the FD&C Act did not preempt a state-law claim alleging that a brand-name prescription

drug manufacturer failed to provide adequate warning of a drug’s risks.57 At the same time, the

Court, without referencing the presumption, has also held that the FD&C Act preempted state-law

claims alleging similar failure-to-warn claims against a generic manufacturer.58 Lower courts

have also disagreed over whether the presumption applies when a case involves the interpretation

of an express preemption clause.59

Preemption and the FD&C Act

Over the FD&C Act’s nearly 90-year history, Congress has significantly expanded the scope of

products subject to the law. The original 1938 FD&C Act regulated drugs, food, medical devices,

and cosmetics,60 but over time, Congress amended the law to add or refine the products—such as

52

A canon of construction is a type of statutory interpretation tool sometimes used by courts to resolve ambiguities in

statutory text. For more information about statutory interpretation and canons of construction, see CRS Report R45153,

Statutory Interpretation: Theories, Tools, and Trends, by Valerie C. Brannon (2023), at 27–39.

53 Rice v. Santa Fe Elevator Corp., 331 U.S. 218, 230 (1947); see also, e.g., Levine, 555 U.S. at 565 (“[I]n all preemption cases, and particularly in those in which Congress has legislated . . . in a field which the States have

traditionally occupied, . . . we start with the assumption that the historic police powers of the States were not to be

superseded by the Federal Act unless that was the clear and manifest purpose of Congress.”) (citations and internal

quotation marks omitted).

54 See Wyeth v. Levine, 555 U.S. 555, 565 (2009).

55 See, e.g., Riegel v. Medtronic, 552 U.S. 312, 334 (2008) (Ginsburg, J., dissenting) (arguing that “Federal laws

containing a preemption clause do not automatically escape the presumption against preemption,” which the majority

did not address in its analysis).

56 Compare, e.g., Levine, 555 U.S. at 565 (stating that the Court’s preemption analysis “must be guided by two

cornerstones,” one of which is that the Court must “start with the assumption that the historic police powers of the

States were not to be superseded by the Federal Act unless that was the clear and manifest purpose of Congress”

(internal quotations omitted)), with Riegel, 552 U.S. at 321–25 (analyzing the preemption question without referencing

presumption against preemption).

57 See infra notes 222–227 and accompanying text.

58 See infra notes 221–233 and accompanying text.

59 Compare, e.g., Dialysis Newco, Inc. v. Cmty. Health Sys. Grp. Health Plan, 938 F.3d 246, 259 (5th Cir. 2019)

(stating that that under the Supreme Court’s decision in Puerto Rico v. Franklin California Tax-Free Trust, 579 U.S.

115, 125 (2016)), a court should not apply any presumption against preemption if the relevant federal statute contains

an express preemption clause); Watson v. Air Methods Corp., 870 F.3d 812, 817 (8th Cir. 2017); EagleMed LLC v.

Cox, 868 F.3d 893, 903 (10th Cir. 2017); Atay v. Cnty. of Maui, 842 F.3d 688, 699 (9th Cir. 2016), with Lupian v.

Joseph Cory Holdings LLC, 905 F.3d 127, 131 n.5 (3d Cir. 2018) (“[W]e have determined that, because [Franklin

California] . . . did not address claims involving areas historically regulated by states, we would continue to apply the

presumption against preemption to express preemption claims.”).

60 Ch. 675, 52 Stat. 1040 (1938).

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

food additives, dietary supplements, and tobacco products—subject to FDA regulation.61 Despite

its expansion, the FD&C Act’s general structure and framework from 1938 remains.

At its heart, the FD&C Act prohibits the distribution of a covered product in interstate commerce

that is “adulterated” or “misbranded.”62 The Act then defines, for each product type, the

circumstances and standards under which that product is “adulterated” or “misbranded.”63 The

law provides FDA with a range of administrative tools to enforce the Act, including warning

letters, import alerts, recalls, debarments, and civil money penalties.64 The scope of some of these

administrative tools differs between product types.65 For all product types, however, a violation of

the FD&C Act can subject a person to civil or criminal enforcement actions before a federal

court.66 With limited exceptions for certain actions that may be brought by a state, the FD&C Act

generally requires “all such proceedings for the enforcement, or to restrain violations of [the

FD&C Act]” to be “by and in the name of the United States,” precluding a private plaintiff from

suing to enforce an FD&C Act requirement.67 Courts have considered both the preemptive effect

of the FD&C Act’s general enforcement scheme, as well as the preemptive effect of FD&C Act’s

product-specific provisions.

Preemption Based on the FD&C Act’s Enforcement Scheme

The FD&C Act’s general enforcement scheme, the Supreme Court has held, impliedly preempts

certain state-law claims based on the theory that a regulated entity made misrepresentations to

FDA during a premarket review process to obtain FDA approval. In Buckman v. Plaintiff’s Legal

Committee, plaintiffs with injuries resulting from the use of orthopedic bone screws sued a

consulting company that had assisted the screw manufacturer in obtaining FDA clearance to

market the devices.68 The plaintiffs, asserting state tort law claims, alleged that the manufacturer

committed fraud on the FDA by giving the agency misleading information in order to obtain this

clearance.69 The plaintiffs argued that had the proper information been provided to the agency,

FDA would not have cleared the devices and the plaintiffs would not have been injured.70

Relying on implied preemption principles—and more specifically, obstacle preemption

principles—the Court held that the plaintiffs’ state-law “fraud-on-the-FDA” claims were

61 See, e.g., Food Additives Amendment of 1958, Pub L. No. 85-929, 72 Stat. 1784 (codified as amended at 21 U.S.C.

§§ 321, 342, 346); Dietary Supplement Health and Education Act of 1994, Pub. L. No. 103-417, 108 Stat. 4325

(codified as amended in scattered provisions of 21 U.S.C. Ch. 9); Family Smoking Prevention and Tobacco Control

Act of 2009, Pub. L. No. 111-31, 123 Stat. 1776 (codified as amended at scattered statutes of 21 U.S.C. Ch. 9). Since

1972, FDA has also regulated biological products. See Suzanne White Junod, Biologics Centennial: 100 Years of

Biologics Regulation, UPDATE, FOOD & DRUG L. INST., Nov.–Dec. 2002, at 40, reprinted by FDA,

https://www.fda.gov/files/Biologics-Centennial--100-Years-of-Biologics-Regulation.pdf [https://perma.cc/C3EK6DC9]. While biological products are subject to regulation under Public Health Service Act (PHSA) section 351, see

supra note 29, PHSA section 351(j) specifically applies FD&C Act requirements to biological products. 42 U.S.C.

§ 262(j).

62 See 21 U.S.C. § 331.

63 See id. §§ 342, 343, 351, 352, 361, 362, 387b, 387c.

64 See CRS Report R43609, Enforcement of the Food, Drug, and Cosmetic Act: Select Legal Issues, by Jennifer A.

Staman (2018), at 10–20.

65 See, e.g., id. at 11–12 (explaining that FDA’s mandatory recall authority does not apply to drug products).

66 See 21 U.S.C. §§ 331–333, 337(a).

67 Id. § 337(a).

68

531 U.S. 341, 343 (2001).

69 Id.

70 Id. at 344.

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preempted because they conflicted with the federal scheme for enforcing the FD&C Act.71 In the

Court’s view, given that the FD&C Act “leaves no doubt that it is the Federal Government rather

than private litigants who are authorized to file suit for noncompliance with the medical device

provisions,”72 state-law fraud-on-the-FDA claims “inevitably conflict with the FDA’s

responsibility to police fraud consistently with the Administration’s judgment and objectives.”73

The Court observed that where a regulated product is subject to a comprehensive premarket

review scheme like the medical device at issue, “complying with the FDA’s detailed regulatory

regime in the shadow of 50 States’ tort regimes will dramatically increase the burdens facing

potential applicants.”74 In the Court’s view, such burdens were “not contemplated by Congress”

when it enacted the FD&C Act and the Act’s amendments governing medical devices.75

While Buckman specifically involved a medical device subject to a premarket review process

known as the section 510(k) clearance process,76 the Court’s reasoning—premised on the FD&C

Act’s enforcement scheme that applies across product types—suggests that state-law “fraud-onthe-FDA” claims related to other products subject to FDA premarket review could be similarly

impliedly preempted under Buckman.77 Subsequent case law, however, shows that this analysis

can depend on the specific structure and operation of applicable state laws. Several states, for

example, have enacted state statutes that generally insulate drug manufacturers from certain tort

claims so long as FDA approved the product at issue.78 These state laws, however, also contain an

exception that preserves tort liability if the manufacturer withheld or misrepresented information

that would have altered FDA’s approval decision.79 In other words, under these state statutes, a

plaintiff must provide evidence of fraud-on-the-FDA not as part of asserting such a claim, but as a

prerequisite to asserting an underlying products liability claim.80 Several lower courts have

considered whether state tort claims asserted under this type of statutory exception were

impliedly preempted under Buckman, and they have reached different conclusions. At least two

appellate courts concluded that because the applicable state law “ultimately requires the plaintiff

to prove that the drug manufacturer defrauded the FDA, it conflicted with the FDA’s duties and

was preempted” under Buckman.81 Another appellate court, however, concluded that under the

relevant state law, the plaintiffs “[were] not pressing ‘fraud-on-the-FDA’ claims” subject to

preemption under Buckman, but rather, they were “asserting claims that sound in traditional state

71 Id. at 348.

72 Id. at 349 n.4.

73 Id. at 350.

74 Id.

75 Id.

76 For information about section 510(k) clearance, see infra “Overview of Selected FD&C Act Provisions on Medical

Devices.”

77 To the extent some Justices have cast doubt over obstacle preemption in general, as discussed above, such doubt

raises a potential question as to Buckman’s validity, should the Supreme Court revisit its obstacle preemption

jurisprudence. However, even if the Supreme Court reconsiders its obstacle preemption jurisprudence, any narrowing

or elimination of the obstacle preemption doctrine may not end the preemption analysis in a given case. Other relevant

FD&C Act provisions may have preemptive effect under other preemption principles. In Buckman, for instance, a

lower court concluded that the state claims were also preempted by the express preemption provision that applies to

medical devices. See 531 U.S. 341 at 347.

78 See, e.g., Desiano v. Warner-Lambert & Co., 467 F.3d 85, 87 (2d Cir. 2006) (analyzing Mich. Comp. Laws

§ 600.2946(5)); Lofton v. McNeal Consumer & Specialty Pharms., 672 F.3d 372, 374 (5th Cir. 2012) (analyzing TEX.

CIV. PRAC. & REM. CODE ANN. § 82.007(a)(1)).

79

See, e.g., Desiano, 467 F.3d at 87; Lofton, 672 F.3d at 374.

80 See Lofton, 672 F.3d at 377.

81 Lofton, 672 F.3d at 377; see also Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961, 965–66 (6th Cir. 2004) (similar).

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

tort law.”82 Because the plaintiffs’ claims, in the court’s view, were “premised on traditional duties

between a product manufacturer and . . . consumers” and were not “derive[d] from, or . . . based

on, a newly-concocted duty between a manufacturer and a federal agency,” such claims were not

preempted under Buckman.83

More broadly, lower courts have also considered whether state-law claims based on state laws

that incorporate or mirror FD&C Act requirements are impliedly preempted under Buckman. The

courts that have considered this question have generally concluded that such claims were not

preempted.84 In Davidson v. Sprout Foods, Inc., consumers of certain baby food products sued the

product maker, alleging that the relevant product labels violated California’s Sherman Law, which

incorporates by reference all federal food labeling requirements.85 The defendant argued, and the

district court agreed, that the plaintiffs’ state claims were preempted under Buckman because

“Sherman Law depends upon and adopts the [FD&C Act] and regulations as state law,” and thus

the claims amounted to an impermissible attempt to privately enforce the FD&C Act.86 Reversing

the district court, the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) held that the

plaintiffs’ claims based on the Sherman Law were not impliedly preempted because the FD&C

Act “did not . . . purport to limit enforcement of . . . parallel state laws in any way.”87 The Ninth

Circuit observed that unlike Buckman, in which the plaintiffs’ state-law claims were premised

solely on violations of FD&C Act duties, the Davidson plaintiffs’ claims were based on violations

of state-law duties, which happened to impose identical standards as federal law.88 The U.S. Court

of Appeals for the Fifth Circuit (Fifth Circuit) applied similar reasoning in Zyla Life Sciences,

L.L.C. v. Wells Pharma of Houston, L.L.C.89 The Fifth Circuit held that a drug manufacturer’s

claims against a competing compounding pharmacy based on state unfair competition law that

incorporated federal standards were not impliedly preempted.90

Preemption Based on FD&C Act’s Product-Specific Provisions

While the core structure and general enforcement scheme of the FD&C Act has remained the

same since 1938, the law’s product-specific provisions and standards have evolved over time and

vary based on a particular product type’s nature and risk profile. Over the years, Congress—in

addition to amending the product-specific standards and provisions—has also added express

preemption provisions in certain parts of the FD&C Act. The Act had no express preemption

82 Desiano, 467 F.3d at 94–95.

83 Id.

84 See, e.g., Davidson v. Sprout Foods, Inc., 106 F.4th 842, 844–45 (9th Cir. 2024); Zyla Life Sci., L.L.C. v. Wells

Pharma of Houston, L.L.C., 134 F.4th 326 (5th Cir. 2024); Allergan, Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350,

1355 (Fed. Cir. 2013). But see Nexus Pharms., Inc. v. Cent. Admixture Pharm. Servs., Inc., 48 F.4th 1040, 1050–51

(9th Cir. 2022).

85 Davidson, 106 F.4th at 844–45.

86 See id. at 847 (internal quotations omitted).

87 Id. at 848.

88 Id. at 848–49.

89 134 F. 4th 326, 331 (5th Cir. 2025).

90 Id. (stating that “[t]he question presented on appeal is whether the state laws somehow conflict with the [FD&C Act]

by incorporating it” and concluding that “[t]hey do not”). But see Nexus Pharms., 48 F.4th at 1050–51 (holding that a

drug manufacturer’s state unfair competition claim against a competing compounding pharmacy was impliedly

preempted because the claim turned on whether the compounded drugs distributed by the defendant qualified for an

exception from FDA approval—a determination regarding whether a violation of the FD&C Act had occurred). The

defendant in Zyla Life has filed a petition for certiorari with the Supreme Court seeking review of the Fifth Circuit’s

decision. Petition for a Writ of Certiorari, Wells Pharma of Houston, L.L.C. v. Zyla Life Sci., L.L.C., No. 25-257 (U.S.

Sep. 2, 2025).

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

provisions until 1976, when Congress enacted the Medical Device Amendments (MDA).91 The

MDA includes a provision that preempts state laws imposing additional or different requirements

related to the safety and efficacy of medical devices.92 Since 1976, Congress has added several

preemption provisions that apply to specific product categories or topics, including with respect

to food labeling,93 cosmetics labeling and packaging,94 and certain tobacco product standards.95

Courts, including the Supreme Court, have weighed in on the preemptive scope of these productspecific FD&C Act provisions on many occasions. Many of these cases focus on the extent to

which the FD&C Act preempts state tort or consumer protection law claims.96 Because the

products regulated by the FD&C Act are generally consumer products, injuries allegedly caused

by such products implicate both state tort law—specifically, state products liability law97—and

state laws protecting consumers from unfair or deceptive practices.98 In suits that alleged products

liability claims, the plaintiffs often asserted that the manufacturer had defectively manufactured

or designed the product at issue, or failed to provide adequate warning of certain risks.99 Had the

manufacturers differently manufactured or designed the product, or provided certain different or

additional warnings, the plaintiffs typically alleged, they would have avoided the injuries.100 With

respect to consumer protection claims, the plaintiffs often alleged that the manufacturers

deceptively or unfairly marketed the relevant products in a manner that harmed the plaintiffs.101

In addition to these tort and consumer protection claims, some courts have also considered

whether and to what extent the FD&C Act preempted certain state statutes enacted to address

certain products or topics also regulated by the Act.

The sections below provide an overview of the preemptive scope of the FD&C Act’s productspecific provisions for food products, prescription drugs, medical devices, cosmetics, and tobacco

products. For each product type, the discussion begins with an overview of selected FD&C Act

provisions and continues with an analysis of relevant case law regarding the provisions’

preemptive scope.

91 See Pub. L. No. 94-295, sec. 521, 90 Stat. 539, 574 (codified as amended at 21 U.S.C. § 360k) (1976).

92 Id.

93 Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, § 6, sec. 403A, 104 Stat. 2353, 2362 (codified

as amended at 21 U.S.C. § 343-1).

94 Food and Drug Administration Modernization Act of 1997, Pub. L. No. 105-115, § 412(d), sec. 752, 111 Stat. 2296,

2376 (codified as amended at 21 U.S.C. § 379s).

95 Family Smoking Prevention and Tobacco Control Act of 2009, Pub. L. No. 111-31, § 101(b), sec. 916, 123 Stat.

1776, 1820 (codified as amended at 21 U.S.C. § 387p).

96 See, e.g., infra “Case Law on the Preemptive Scope of Selected Prescription Drug Provisions”; “Case Law on the

Preemptive Scope of FD&C Act Section 916.”

97 See supra note 20.

98 See NAT’L CONSUMER L. CTR., supra note 18, at 1–3.

99

See, e.g., infra “Case Law on the Preemptive Scope of Selected Prescription Drug Provisions.”

100 See infra “Case Law on the Preemptive Scope of Selected Prescription Drug Provisions.”

101 See, e.g., infra “Case Law on the Preemptive Scope of FD&C Act Section 916.”

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Food Products102

Overview of Selected FD&C Act Provisions on Food Products

The original 1938 FD&C Act prohibited the introduction of misbranded or adulterated food in

interstate commerce.103 Under the law, such food products were misbranded if, for instance, their

labeling included false and misleading statements; such products were adulterated, for instance, if

their content did not comply with established mandatory food standards called standards of

identity.104 Over the years, Congress amended the FD&C Act’s food provisions on many

occasions to impose additional requirements.105 For example, while most food products do not

need to undergo premarket review before they can be lawfully marketed, Congress, under the

Food Additives Amendment of 1958106 and the Color Additive Amendments of 1960,107 created a

system of premarket review of certain food ingredients. In 1990, Congress also enacted the

Nutrition Labeling and Education Act (NLEA), which amended the FD&C Act to establish

uniform labeling requirements for food sold in interstate commerce.108

Under current law, food products must comply with various labeling requirements. For instance, a

food label must bear,109 if applicable, the name of the food specified in the relevant standard of

identity, which defines the mandatory or optional ingredients and characteristics of a food.110 If

there is no relevant standard of identity, the food label must bear the common or usual name of

the food.111 A food is deemed misbranded under the Act if the food’s label represents the product

as a food for which a standard of identity has been issued, and the product does not conform to

the definition.112

Labels of food in package form must also bear nutrition information, including the serving size,

the number of servings per container, and the amounts of nutrients in each serving size.113 This

information must appear on an “information panel,” or the part of the label immediately to the

right of the package’s principal display that is most likely to be shown to consumers in retail

102 Except in limited circumstances, food as defined by the FD&C Act includes dietary supplements. See 21 U.S.C.

§ 321(ff). Because an analysis of the courts’ preemption jurisprudence relating to dietary supplements is beyond the

scope of this report, this report uses the terms food products or food to refer to non-dietary-supplement food products.

103 Ch. 675, 52 Stat. 1040 (1938). FDA and the U.S. Department of Agriculture (USDA) share responsibility for food

regulation. USDA regulates certain meat, poultry, and egg products, and FDA regulates all other foods. See Formal

Agreement Between USDA and FDA Relative to Cooperation and Coordination, FDA,

https://www.fda.gov/food/international-interagency-coordination/formal-agreement-between-usda-and-fda-relativecooperation-and-coordination [https://perma.cc/3LEA-73DU] (last visited Mar. 19, 2026). USDA’s regulation of food

is beyond the scope of this report.

104 The Federal Food, Drug, and Cosmetic Act of 1938, 52 Stat. 1040 (1938) (codified at 21 U.S.C. §§ 321, et. seq.);

see also HUTT ET AL., supra note 16, at 469.

105 See, e.g. Food Additives Amendment of 1958, Pub. L. No. 85-929, 72 Stat. 1784 (1958).

106 Id.

107 Pub. L. No. 86-618, 74 Stat. 397 (1960).

108 Nutrition Labeling and Education Act of 1990, Pub. L. No. 101-535, 104 Stat. 2353.

109 21 U.S.C. § 343(g).

110 Id. § 341; 21 C.F.R. §§ 131.3–169.182 (2025) (standard of identity regulations). The FD&C Act directs FDA to

promulgate standards of identity whenever “such action will promote honesty and fair dealing in the interest of

consumers.” 21 U.S.C. § 341.

111

Id. § 343(i).

112 Id. § 343(g).

113 See 21 U.S.C. § 343(q)

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sale.114 In addition, FDA regulations set out requirements for nutrient content claims that may be

included on food packages.115 A nutrient content claim characterizes the level of a nutrient in a

product.116 If a manufacturer chooses to include a nutrient content claim on a product’s label,117

the claim must meet the applicable regulatory requirements.118 For example, FDA regulations

define many terms, including “more,” “fortified,” “enriched,” “high potency,” “light ,” “free,”

and “low” and specify the conditions under which manufacturers may use these terms on their

labels.119

In addition to labeling requirements, FDA must approve the use of certain food ingredients called

food additives as safe before they can be used in products.120 Food containing any food additive

that has not been approved as safe is deemed to be adulterated and may be subject to FDA

enforcement.121 The FD&C Act defines food additive as “any substance the intended use of which

results or may reasonably be expected to result, directly or indirectly, in its becoming a

component or otherwise affecting the characteristics of any food” if the substance is not generally

recognized as safe (GRAS).122 A substance is GRAS—and therefore not a food additive subject to

premarket review—if “experts qualified by scientific training and experience to evaluate its

safety” generally recognize the intended use of the substance to be safe.123 According to this

statutory definition, qualified experts must base their view of a general recognition of safety on

either (1) scientific procedures or (2) common use of a substance in food prior to January 1,

1958.124 FDA has promulgated regulations recognizing certain ingredients as GRAS, which is

sometimes called the GRAS list.125 This list, however, is not comprehensive because it “is

impracticable to list all substances that are [GRAS].”126

114 21 C.F.R. §§ 101.2(b), 101.2(d), 101.1 (2025).

115 Id. § 101.72. The FD&C Act also imposes requirements on health claims, which are claims that link the

consumption of a nutrient to a disease or health-related condition. 21 U.S.C. § 343(r)(1)(B). For example, a label for a

product that is high in calcium (such as milk) may state that consuming the product may reduce the risk of

osteoporosis. 21 C.F.R. § 101.72 (2025). The FD&C Act allows a manufacturer to include a health claim on a food’s

label only when FDA has promulgated a regulation approving the health claim, based on a determination that there is

“significant scientific agreement” among qualified experts that the claim is supported. 21 U.S.C. § 343(r). To date,

FDA has promulgated regulations approving 12 health claims. See 21 C.F.R §§ 101.72–101.83 (2025). FDA has also

opted to exercise enforcement discretion to allow the use of certain so called “qualified health claims” that do not meet

the statutory criteria with the use of an appropriate disclaimer. See Guidance for Industry: FDA’s Implementation of

Qualified Health Claims: May 2006, FDA (Sep. 20, 2018), https://www.fda.gov/regulatory-information/search-fdaguidance-documents/guidance-industry-fdas-implementation-qualified-health-claims [https://perma.cc/Z6TZ-N523].

116 21 U.S.C. § 343(r)(1)(A).

117 21 C.F.R. § 101.13(b) (2025).

118 Id. §§ 101.54–101.69.

119 See id. §§ 101.54–101.62.

120 21 U.S.C. §§ 342(a), 348(a)–(g).

121 Id. § 342(a).

122 Id. § 321(s).

123 Id.

124 Id.

125 See 21 C.F.R. pt. 182 (2025).

126 Id. § 182.1(a) (“It is impracticable to list all substances that are generally recognized as safe for their intended use.

However, by way of illustration, the Commissioner regards such common food ingredients as salt, pepper, vinegar,

baking powder, and monosodium glutamate as safe for their intended use.”).

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Selected FD&C Act Provisions on Preemption Related to Food Products

Recognizing the role that states and localities traditionally play in food regulation, Congress has

directly addressed the interplay between the FD&C Act and state and local law through several

express preemption and “no preemption” provisions. For example, section 416 of the FD&C Act

directs FDA to promulgate regulations that generally require those engaged in the transportation

of food to use sanitary transportation practices prescribed by the agency.127 Subsection (e) of

section 416 generally preempts state or local requirements “concern[ing] the transportation of

food” if complying with both federal and state/local requirements is impossible or if complying

with state/local requirements presents an obstacle to carrying out the federal requirements.128 On

the other hand, other FD&C Act provisions, under the heading of “No preemption,” expressly

preserve any non-federal requirements.129 FD&C Act section 418(i)(6), for example, expressly

preserves any “non-Federal law regarding the safe production of food.”130 Similarly, section

419(f)(5) preserves any “non-Federal law regarding the safe production, harvesting, holding,

transportation, and sale of fresh fruits and vegetables.”131

With respect to food labels, the FD&C Act, as amended by the NLEA, also includes an express

preemption provision, entitled “National Uniform Nutrition labeling,” that forbids states and

localities from establishing any requirement that is “not identical to” specified federal

requirements related to food labeling.132 This labeling preemption provision (FD&C Act section

403A) states the following:

(a) Except [in certain circumstances], no State or political subdivision of a State may

directly or indirectly establish under any authority or continue in effect as to any food in

interstate commerce—

(1) any requirement for a food which is the subject of a standard of identity established

under section [401] of this title that is not identical to such standard of identity or that

is not identical to the requirement of section [403(g)] of this title, except [in certain

circumstances],

(2) any requirement for the labeling of food of the type required by section [403(c),

403(e), 403(i)(2), 403(w), or 403(x)] of this title that is not identical to the requirement

of such section, except [in certain circumstances],

(3) any requirement for the labeling of food of the type required by section [403(b),

403(d), 403(f), 403(h), 403(i)(1), or 403(k)] of this title that is not identical to the

requirement of such section, except [in certain circumstances],

(4) any requirement for nutrition labeling of food that is not identical to the

requirement of section [403(q)] of this title, except [in certain circumstances], or

(5) any requirement respecting any claim of the type described in section [403(r)(1)]

of this title made in the label or labeling of food that is not identical to the requirement

of section [403(r)] of this title, except [in certain circumstances].133

127 21 U.S.C. § 350e(b).

128 Id. § 350e(e)(1).

129 See id. §§ 350g(l)(6), 350h(f)(5).

130 Id. § 350g(l)(6).

131 Id. § 350h(f)(5). Both of the “no preemption” provisions in sections 418(l)(6) and 419(f)(5) state that compliance

with applicable federal law does “not relieve any person from liability” under relevant state law. 21 U.S.C.

§§ 350g(l)(6), 350h(f)(5).

132 Id. § 343-1(a).

133 Id. § 343-1.

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

This preemption provision cross-references numerous requirements or prohibitions of the FD&C

Act’s misbranded food section under section 403.134 The cross-referenced provisions include, for

instance, labeling requirements related to a food’s standard of identity, nutritional information,

and nutrient content claims, limiting states’ ability to establish requirements that are “not

identical” to these federal requirements.135

The NLEA also contains a savings clause that limits FD&C Act section 403A’s preemptive effect

and expressly preserves certain types of state laws or remedies.136 The clause provides that “[the

NLEA] shall not be construed to preempt any provision of State law, unless such provision is

expressly preempted under FD&C Act section 403A.”137 It further states that section 403A “shall

not be construed to apply to any requirement respecting a statement in the labeling of food that

provides for a warning concerning the safety of the food or component of the food.”138 The

provision also clarifies that section 403A “shall not be construed to affect” the preemptive scope

of any other provision of the FD&C Act.139

Case Law on the Preemptive Scope of Selected FD&C Act Provisions on Food

Products

To date, courts that have considered the preemptive effect of the FD&C Act provisions governing

food products have primarily considered whether and to what extent FD&C Act section 403A

expressly preempts consumers’ state-law claims regarding a food label. These consumer claims

generally involve state consumer protection or tort claims alleging that a food label is misleading

or does not adequately warn of the risks associated with a food product.140 In addition, at least one

court has considered the preemptive effect of FDA’s GRAS determination on a state statute

prohibiting that substance.141

Case Law on the Preemptive Scope of FD&C Act Section 403A on Food Labeling

Although the U.S. Supreme Court has not addressed the scope of FD&C Act section 403A, lower

courts have opined on the extent to which consumer state-law claims are preempted by the clause.

Generally, lower courts have held that state-law claims that were interpreted to impose additional

or different labeling requirements from what applicable FDA regulations require were preempted

because such state claims sought to impose labeling that was “not identical” to federal

requirements under FD&C Act section 403A.142

134 See id.

135

See id. § 343.

136 21 U.S.C. § 343-1 notes. The savings clause is not codified, but rather included in the statutory notes. Id. When a

public law is added to a statutory note, it has the same legal effect as a public law that is added to the code. See Aldana

v. Del Monte Fresh Produce, N.A., Inc., 416 F.3d 1242, 1251 (11th Cir. 2005) (per curiam) (“That the [Torture Victim

Protection Act of 1991 (TVPA)], which was published in the Statutes at Large, appears in the United States Code as a

historical and statutory note to the Alien Tort Act does not make the TVPA any less the law of the land.”).

137 21 U.S.C. § 343-1 notes.

138 Id.

139 Id.

140 See e.g. Nemphos v. Nestle Waters N.A., Inc., 775 F.3d 616, 618 (4th Cir. 2015) (considering state tort law claims

that Nestle failed to warn consumers of the risk of dental fluorosis and claims that Nestle violated the Maryland

Consumer Protection Act, which prohibits unfair and deceptive trade practices acts, by engaging in misleading

marketing).

141 Marrache v. Bacardi, U.S.A, 17 F.4th 1084, 1089 (11th Cir. 2021).

142 See Nemphos, 775 F.3d at 625 (“The warning requirement Nemphos seeks is simply not identical to the FDA’s

(continued...)

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

For example, in Pardini v. Unilever United States, the Ninth Circuit considered the plaintiffs’

allegations that the “I Can’t Believe It’s Not Butter! Spray” product’s label misrepresented its fat

and calorie content.143 The plaintiffs alleged that the front of the product’s label, which claimed

that it has 0 calories and 0 grams of fat, was misleading because the 12-ounce bottle of the

product contains 1160 calories and 124 grams of fat.144 The defendant argued that the plaintiffs’

claim that the label was misleading was preempted because the label’s claims complied with FDA

regulations that specifically governed “zero fat” claims and that the plaintiffs were seeking to

impose different labeling requirements.145 The court agreed with the defendant. In particular, the

court observed that under applicable FDA regulations, for products categorized as a “spray type,”

their amount of fat and calories must be expressed in terms of a prescribed serving size of 0.25

grams.146 When the amount of fat and calories in a designated serving size was below a certain

threshold (5 calories and 0.5 grams of fat), the regulations also required the product to reflect that

the product has zero calories or fat per serving on the label’s information panel.147 The court

concluded that because the defendant properly categorized the product as a “spray type,” its

nutrition labeling complied with the relevant requirements, which allowed for the defendant to

round the amount of calories and fat down to zero.148 Accordingly, the court held that the

plaintiffs’ claim—which would have required the defendant to label the product differently from

what FDA regulations required—was expressly preempted.149

Courts have also held that state-law claims seeking to impose additional disclosures beyond what

FDA regulations require would impose a requirement that is “not identical to” the FD&C Act

requirements and are therefore preempted.150 For example, in Turek v. General Mills, the

manufacturer of a “chewy bar” included claims on the front of its label that the product contained

“35% of your daily fiber” and called it “Fiber Plus.”151 The plaintiff alleged that the product

contained “non-natural fiber” which provided fewer of the benefits of consuming fiber, may

cause stomach problems in some people, and may be harmful to women who were pregnant or

breastfeeding.152 The plaintiff argued that the product’s label was misleading because it did not

disclose that the product used an inferior form of fiber that was not “natural” and may be harmful

to some.153 The U.S. Court of Appeals for the Seventh Circuit (Seventh Circuit) held that the

labeling claims challenged by the plaintiff were compliant with all applicable FDA regulations

existing standard of identity. As such, her failure-to-warn claim is preempted.”); Young v. Johnson & Johnson, 525 F.

App’x 179, 185 (3d Cir. 2013) (“Because Young’s state law action seeks to impose standards that are not identical to

those set forth in the regulations, it is expressly preempted by the NLEA as it relates to those claims”).

143 Pardini v. Unilever United States, Inc., 65 F.4th 1081, 1083 (9th Cir. 2023).

144 Id.

145 Id. at 1084.

146 Id. at 1089–90 (citing 21 C.F.R. § 101.12(b) (“The [reference amounts in the chart] shall be used as the basis for

determining serving sizes for specific products”)).

147 Id. at 1085 (citing 21 C.F.R. §§ 101.9(c)(1), 101.9 (c)(2), 101.60(b)(1)(i), 101.62(b)(1)(i)).

148 Id. at 1091.

149 Id.

150 Turek v. Gen. Mills, Inc., 662 F.3d 423, 427 (7th Cir. 2011) (“The disclaimers that the plaintiff wants added to the

labeling of the defendants’ inulin-containing chewy bars are not identical to the labeling requirements imposed on such

products by federal law, and so they are barred.”); Nemphos, 775 F.3d at 625 (“[The plaintiff] seeks a required warning

that is additional to and certainly ‘not identical to’ the federal standard. The FDA’s standard of identity . . . does not

demand a warning about dental fluorosis.” (quoting 21 C.F.R. § 100.1(c)(4)).

151

Turek, 662 F.3d at 425.

152 Id. at 426.

153 Id.

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related to dietary fiber.154 Because the disclaimers the plaintiff sought to add to the label “[were]

not identical to the labeling requirements imposed on such products by federal law,” they were

expressly preempted.155

In contrast, courts have generally held that two kinds of state-law claims are not preempted by

FD&C Act section 403A: (1) state claims that allege as false or misleading certain labeling claims

that a defendant is not specifically required or permitted to include by FDA regulations;156 and (2)

state claims that seek to impose requirements interpreted to be identical to what federal law

requires.157

Courts have generally held that claims focused on additional labeling claims not specifically

required or permitted by FDA regulations that a defendant chose to include were not preempted

by FD&C Act section 403A.158 For example, in Hawkins v. Kroger Company, the Ninth Circuit

held that a plaintiff’s claim—that a bread crumb product’s front label stating that the product had

“0g Trans Fat per serving” was misleading because the product did have small amounts of trans

fat—was not preempted.159 The court observed that while FDA regulations required the amount of

trans fat per serving to be stated on the information panel on the side of the label and required

such amount to be expressed as zero “[i]f the serving contains less than 0.5 gram,” these

requirements did not apply to nutrient content claims—which can only be made if they were not

“false or misleading in any respect”—on the front of the label.160 The court further observed that

FDA had “explicitly decided not to authorize a ‘No Trans Fat’ nutrient content claim in light of a

lack of scientific information.”161 Accordingly, the court held that because FDA regulations did

not “authorize the contested statement,” the state-law claims were not preempted.162

Similarly, in Bell v. Publix Super Markets, the Seventh Circuit held that certain consumers’ statelaw claims—that a product’s label stating it was “100% Grated Parmesan Cheese” was

misleading because the product contained cellulose powder and potassium sorbate to prevent the

grated cheese from caking and getting moldy—were not preempted by federal law.163 Under

federal law, grated cheese is subject to an FDA standard of identity that allows products labeled

as “grated cheese” to include cellulose powder and potassium sorbate,164 and the defendant

argued that because it had complied with the standard, the plaintiffs’ claims were preempted

154 Id. at 426–27.

155 Id. at 427.

156 See, e.g., Bell v. Publix Super Markets Inc., 982 F.3d 468, 474 (7th Cir. 2020).

157 See Lilly v. ConAgra, 743 F.3d 662, 665 (2014).

158 Bell, 982 F.3d at 474; see also, Chacanaca v. Quaker Oats Co., 752 F. Supp. 2d 1111, 1123 (N.D. Cal. 2010)

(determining deceptive labeling claims regarding pictures on the front of the label, which are not regulated by the

FD&C Act, and the phrase “wholesome,” for which FDA has not issued a regulation, are not preempted).

159 Hawkins v. Kroger Co., 906 F.3d 763, 767, 773 (9th Cir. 2018).

160 Id. at 770 (internal quotations omitted). See also id. (“‘Information that is required or permitted by § 101.9 . . . and

that appears as part of the nutrition label, is not a nutrient content claim . . . . If such information is declared elsewhere

on the label . . . it is a nutrient content claim and is subject to the requirements for [such] claims.’” (alteration in

original) (quoting 21 C.F.R. § 101.13(c))). Unlike in Pardini, in which a challenged nutrient content claim on the front

label was explicitly permitted by applicable FDA regulation, see 21 C.F.R. § 101.62(b), the challenged nutrient content

claim in Hawkins was not subject to applicable FDA regulation. See Hawkins, 906 F.3d at 771.

161 Id. at 771.

162 Id. at 772.

163 Bell, 982 F.3d at 474.

164 See 21 U.S.C. § 343(g) (“A food shall be deemed to be misbranded . . . If it purports to be or is represented as a food

for which a definition and standard of identity has been prescribed by regulations . . . unless (1) it conforms to such

definition and standard, and (2) its label bears the name of the food specified in the definition and standard . . .”); 21

C.F.R. § 133.146 (standard of identity for grated cheeses).

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

because they sought to impose different standard-of-identity requirements.165 The Seventh Circuit

rejected this argument, reasoning that because the standard-of-identity regulation does not address

whether products may be labeled with an additional modifier such as “100%,” a state-law claim

seeking to prevent its use in certain circumstances did not establish a new requirement different

from the standard of identity.166 Because the plaintiffs were seeking to “stop defendants from

voluntarily adding deceptive language to the federally permitted label,”167 the court concluded

that the state-law claims based on defendant’s use of the “100%” modifier were not preempted.168

A second category of state-law claims that courts have held are not preempted by FD&C Act

section 403A are those that seek to impose requirements interpreted to be identical to those set out

in FDA regulations.169 For example, in Lilly v. ConAgra Foods, the Ninth Circuit concluded that a

plaintiff’s claim under state law—that defendant’s sunflower seed label misrepresented the

amount of sodium content of the sunflowers—was not preempted by federal law.170 The plaintiff

alleged that the sunflower seed label declared the amount of salt in the sunflower seed but did not

include the amount of salt that was in the coating on the sunflower shell.171 The defendant argued

that under federal law, manufacturers need not include the amount of sodium on inedible

components like the shell, and therefore the plaintiff’s claim imposed requirements that differed

from federal requirements and thus was preempted.172 Siding with the plaintiff, the court observed

that applicable FDA regulations required declaration of the amounts of nutrient and food

component content to be “based on only the edible portion of food, and not bone, seed, shell, or

other inedible components.”173 The court reasoned that, even though the sunflower seed shell is

not meant to be consumed, the coating on the shell is edible and therefore must be included in the

sodium declaration on the food’s label.174 The court concluded that because the “plaintiff’s statelaw claims, if successful, would impose no greater burden than those imposed by federal law, her

state-law claims [were] not preempted.”175

Case Law on the Preemptive Scope of FDA’s GRAS Regulation

While the majority of courts that have considered the preemptive effect of the FD&C Act’s food

provisions have focused on section 403A, at least one court has considered the implied

preemptive effect of the FD&C Act’s food additive and GRAS regulations on state statutes that

restrict the use of certain substances in food.176 Concerns over the safety of certain food

165 See Bell, 982 F.3d at 483–84.

166 Id. at 484.

167 Id. The court noted that the NLEA preemption clause does not include the FD&C Act’s general prohibition of “false

or misleading” labeling, and therefore the preemption clause “does not expressly preempt state-law prohibitions on

deceptive statements that sellers add voluntarily to their labels or advertising.” Id. (quoting 21 U.S.C. § 343(a)).

168 Id. at 485. The court also briefly addressed the argument that the FD&C Act impliedly preempted the plaintiff’s

claims, concluding that impossibility preemption did not apply because it was possible to comply with applicable state

and federal requirements. Id. at 486.

169 See Lilly v. ConAgra, 743 F.3d 662, 665 (2014).

170 Id.

171 Id. at 664.

172 Id. at 665.

173 Id. (quoting 21 C.F.R. §§ 101.9(b), 101.12(a)(6)).

174

Id.

175 Id. at 663.

176 See Marrache v. Bacardi, U.S.A, 17 F.4th 1084, 1089 (11th Cir. 2021).

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ingredients have led several states to enact legislation that would prohibit the use of certain food

substances.177

In Marrache v. Bacardi, the U.S. Circuit Court for the Eleventh Circuit (Eleventh Circuit)

considered a Florida law that banned adding certain substances to liquor and held that the state

law was not preempted.178 The Florida law at issue banned the use of, among other things, grains

of paradise, a botanical that was used in one of the defendant manufacturer’s gin products.179

Grains of paradise, however, is included on the non-exhaustive list of GRAS substances

promulgated by FDA and expressly identified by the agency as “generally recognized as safe.”180

A consumer sued the defendant manufacturer, asserting that the defendant violated state consumer

protection laws by selling products containing an ingredient banned under state law.181 In

response, the defendant argued, among other things, that the plaintiff’s claims were preempted

because the underlying state law conflicted with applicable federal regulations because it

prohibited the use of a food substance FDA had specifically found to be GRAS.182

The court rejected the defendant’s argument, concluding that the state law was not preempted

because it was not impossible for the defendant to comply with both state and federal law, nor did

the Florida law frustrate the purposes of the Food Additives Amendment.183 The court first

concluded that compliance with both laws was possible because while FDA had determined

grains of paradise to be GRAS, permitting them to be included in food or alcohol, neither the

FD&C Act nor its implementing regulations required foods with grains of paradise to be sold in

all states.184 Thus, the court reasoned, the defendant may comply with both federal and state law

“by selling [its product] without grains of paradise in Florida while selling [its product] with

grains of paradise in other states.”185 The court next concluded that the Florida law did not

frustrate Congress’s purpose in enacting the Food Additives Amendment.186 Congress’s purpose

in enacting the Food Additives Amendment—“as derived from the statutory text—was to prohibit

unsafe food additives from being included in food and alcohol to protect the health and safety of

the public.”187 The court reasoned that the statute does not indicate that Congress intended to

require states to allow the sale of GRAS substances.188

177 See, e.g., CAL. HEALTH & SAFETY CODE § 109025(a) (West 2026) (prohibiting the sale of a food product for human

consumption that contains brominated vegetable oil, potassium bromate, or propylparaben); TEX. EDUC. CODE ANN.

§ 33.901(b) (West 2026) (banning certain food additives including brominated vegetable oil in school lunches).

178 Marrache, 17 F.4th at 1092–97. At least one other court has considered a challenge of another state law restricting

the use of certain substances in food. In International Ass’n of Color Manufacturers v. Singh, the district court

considered a West Virginia law banning “‘any added substance or ingredients which are poisonous or injurious to the

health’” including several color additives. No. 2:25-cv-00588, 2025 WL 3721864, at *2 (S.D.W. Va. Dec. 23, 2025)

(quoting W. VA. CODE § 16-7-2(b)(7)). The court preliminarily enjoined the state from enforcing the law after

determining that the plaintiff was likely to succeed on the merits of its claim that the phrase “poisonous or injurious to

the health” is “unconstitutionally vague” and “leaves the door open for arbitrary enforcement.” See id. at *10–11. The

plaintiff in Singh did not argue that the West Virginia ban was preempted by the FD&C Act. See id. at *3–12.

179 FLA. STAT. § 501.212.

180 Id. § 182.10.

181 Marrache, 17 F. 4th at 1089–90.

182 Id. at 1091.

183 Id. at 1095–97.

184 Id. at 1095.

185 Id.

186

Id. at 1096–97.

187 Id. at 1097.

188 Id.

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Prescription Drugs

Overview of Selected FD&C Act Provisions on Prescription Drugs

Since the original FD&C Act was enacted in 1938, there has been a federal system of premarket

review of new drugs in the United States.189 The initial system, however, was more akin to a

notification system. The process required a manufacturer to submit a new drug application,

including evidence of the drug’s safety, to FDA for review but generally allowed the application

to take effect after 60 days unless FDA could show that the drug was not safe for use as

labeled.190 In 1962, Congress enacted the Kefauver-Harris Drug Amendments (Drug

Amendments) in response to incidences of birth defects caused by thalidomide in other countries,

revamping the drug preapproval process.191 The Drug Amendments not only require FDA to

affirmatively approve a new drug application before a drug could be marketed, shifting the

burden to prove safety from FDA to the manufacturer, but also require that a manufacturer

demonstrate that a new drug is both safe and effective for its intended use.192

Under current law, to market a new drug, a manufacturer must file with FDA a New Drug

Application (NDA), which must include, among other things, “full reports” of investigations into

the drug’s safety and effectiveness; a list of the drug’s components; and “specimens of the

labeling proposed to be used for such drug.”193 The FD&C Act directs FDA to deny an NDA if it

finds, for example, the reports of testing show that the drug is unsafe or ineffective or if the

“proposed labeling” does not make the drug “safe for use under the conditions prescribed,

recommended, or suggested.”194 Where “necessary to ensure that the benefits of the drug

outweigh the risks,” FDA may also approve a drug subject to a risk evaluation and mitigation

strategy, or REMS.195 A REMS is a drug safety plan that mitigates the risks of a drug using

strategies beyond FDA-approved labeling.196 Such strategies may include dissemination of

additional patient information, development of a communication plan with health care providers,

and restrictions on distribution (e.g., by requiring dispensing entities to obtain special

certifications).197

Once FDA has approved an NDA, the agency places the drug at issue on a public list of approved

drugs.198 The drugs on this list are known as listed drugs.199 The law requires post-market

surveillance of the drug by FDA, and requires the agency to withdraw approval of a new drug if it

finds that the drug is unsafe, or that there is a lack of substantial evidence that the drug is

effective.200 The manufacturer must also comply with certain post-approval requirements,

189 See ch. 675, 52 Stat. 1040 (1938).

190 See Wyeth v. Levine, 555 U.S. 555, 566–67 (2009).

191 Pub. L. No. 87-781, 76 Stat. 780 (1962); see also Part III: Drugs and Foods Under the 1938 Act and Its

Amendments, FDA (Feb. 1, 2018), https://www.fda.gov/about-fda/changes-science-law-and-regulatory-authorities/partiii-drugs-and-foods-under-1938-act-and-its-amendments [https://perma.cc/UQK8-NUDL] (providing an overview of

the history of the amendments of FD&C Act’s prescription drug provisions).

192 See Levine, 555 U.S. at 566–67.

193 21 U.S.C. § 355(b)(1).

194 Id.

195 Id. § 355-1.

196 See id. § 355-1(e) & (f).

197 See id.

198

Id. § 355(j)(7).

199 Id. § 355(j)(2)(A)(i).

200 Id. § 355(e)

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including reporting “adverse events” to FDA and periodically submitting any new information

that may affect the FDA’s previous conclusions about the safety, effectiveness, or labeling of the

drug.201 While the manufacturer generally cannot make changes to the drug, including “[c]hanges

in labeling,” without obtaining FDA approval for the change,202 FDA’s “Changes Being Effected”

regulations permit a manufacturer to add or strengthen a warning without prior approval by

FDA.203

If a manufacturer wants to market a generic version of an already-approved brand-name drug, the

manufacturer can file an abbreviated new drug application (ANDA) to show that the generic drug

is therapeutically equivalent to a brand-name drug (i.e., a listed drug).204 An ANDA generally

must include “information to show that the new drug is bioequivalent to the listed drug,”205 and

“information to show that the labeling proposed for the new drug is the same as the labeling

approved for the listed drug.”206 The generic applicant is not required to conduct its own safety

and effectiveness testing, but is permitted to rely upon the safety and effectiveness evidence

presented in the NDA for the listed drug.207 The FDA may withdraw approval of an ANDA for a

generic drug if it finds that the labeling for the generic drug “is no longer consistent with that for

the listed drug.”208 The current NDA holder of a brand-name drug may change a drug’s labeling,

but a generic drug manufacturer cannot and generally must ensure that its labeling remains the

same as the labeling for the listed drug.209

Drugs manufactured in foreign countries that are imported into the United States for commercial

distribution must comply with the same FD&C Act requirements as domestically manufactured

drugs, including premarket approval.210 Foreign-made drugs that have not undergone premarket

approval, even if made with the same active ingredient as an FDA-approved drug, are generally

considered unapproved new drugs that cannot be introduced into the U.S. market.211 FD&C Act

section 801(d)(1)(B) explicitly prohibits the importation of unapproved prescription drugs for

commercial use, with two exceptions: (1) when authorized by the Secretary of Health and Human

Services (HHS) pursuant to a drug shortage, and (2) pursuant to an FDA-authorized drug

importation program under FD&C Act section 804.212

201 Id. § 355(k).

202 See 21 C.F.R. § 314.70(b)(1)-(2) (2025).

203 Id. § 314.70(c)(6)(iii). The labeling change must be submitted to FDA in a supplemental NDA, which FDA may

disapprove. If the agency disapproves the supplemental NDA, “it may order the manufacturer to cease distribution” of

the relevant drug product. Id. § 314.70(c)(7).

204 21 U.S.C. § 355(j).

205 Id. § 355(j)(2)(A)(iv).

206 Id. § 355(j)(2)(A)(v).

207 See SmithKline Beecham Consumer Healthcare, L.P. v. Watson Pharm., Inc., 211 F.3d 21, 26 (2d Cir. 2000).

208 21 C.F.R. § 314.150(b)(10) (2025).

209 Id. §§ 314.94(a)(8), 314.127(a)(7). Certain limited differences in the labeling of the generic and the reference listed

drug may be permitted. For instance, a generic drug manufacturer may propose labeling that omits the portions of the

reference listed drug’s labeling that are covered by an applicable patent or exclusivity. See id. For more information

about this labeling difference—resulting in what is commonly known as a “skinny label” for the generic version—see

CRS In Focus IF12700, “Skinny Labels” for Generic Drugs Under Hatch-Waxman, by Kevin J. Hickey (2026).

210

See 21 U.S.C. §§ 331, 351, 355(a).

211 See id.

212 Id.§ 381(d)(1).

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Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Added to the FD&C Act in the early 2000s,213 section 804 authorizes FDA to promulgate

regulations to establish a drug importation program under which pharmacists and wholesalers

could import certain unapproved prescription drugs from Canada into the United States.214 In

order for the program to become effective, the HHS Secretary must certify that the program

would pose no additional risk to the public’s health and safety and would offer “significant

reduction in the cost” to U.S. consumers.215 The HHS Secretary made the requisite certification

for the first time in 2020, and issued a final rule implementing the importation program.216 Under

the program, states and Indian Tribes may submit proposals to FDA to, on a time-limited basis,217

import Canada-approved versions of certain FDA-approved prescription drugs.218 Section 804(j)

grants FDA the authority to waive the importation requirements for certain cases of importation

for personal use that are consistent with FDA guidance.219

Case Law on the Preemptive Scope of Selected Prescription Drug Provisions

The FD&C Act’s prescription drug provisions do not contain an express preemption provision.220

Because prescription drugs are often the subject of state products liability lawsuits, courts are

frequently confronted with questions regarding whether and to what extent the FD&C Act’s

elaborate premarket approval scheme for drugs impliedly preempts state-law claims that allege

that a drug manufacturer inadequately warned of the risks of, or defectively designed, a drug. In

addition to the premarket approval scheme, some courts have also considered how other aspects

of the FD&C Act’s prescription drug regulation—such as the Act’s importation and REMS

restrictions—impliedly preempt related state laws.

Case Law on the Preemptive Scope of Prescription Drug’s Premarket Approval Scheme

With respect to the FD&C Act’s preemption of state tort law claims, the Supreme Court has

weighed in on these questions on multiple occasions, describing the preemption issues presented

as “difficult . . . questions” that have “repeatedly vexed the Court.”221 In several cases, the

Supreme Court considered the circumstances under which the FD&C Act preempts state claims

alleging that a drug manufacturer failed to provide adequate warnings about the risks of a drug.

213 The provision was first added by the Medicine Equity and Drug Safety Act, Pub. L. No. 106-387, § 745, 114 Stat.

1549, 1549A–36 (2000) and amended by the Medicare Prescription Drug, Improvement, and Modernization Act of

2003, Pub. L. No. 108-173, § 1121(a), sec. 804, 117 Stat. 2066, 2464.

214 21 U.S.C. § 384(b). Under applicable implementing regulations, a prescription drug is eligible for importation if it is

approved by Health Canada (the relevant Canadian regulatory agency) and an FDA-approved version of the drug is

currently marketed in the United States. 21 C.F.R. § 251.2 (2025).

215 Id. § 384(l)(1).

216 See Importation of Prescription Drugs, 85 Fed. Reg. 62094, 62095 (Oct. 1, 2020) (codified at 21 C.F.R. pts. 1, 251).

217 21 C.F.R. § 251.6 (2025) (stating that authorization for an authorized importation program typically terminates

automatically after two years, or a shorter period if a shorter period is authorized).

218 See id. §§ 251.1(a), 251.2 (definitions of “eligible prescription drug” and “Section 804 Importation Program

Sponsor (‘SIP Sponsor’)”).

219 21 U.S.C. § 384(j).

220 The Drug Amendments of 1962 included a provision stating that “[n]othing in the amendments made by this Act . . .

shall be construed as invalidating any provision of State law . . . unless there is a direct and positive conflict between

such amendments and such provision of State law.” Pub. L. No. 87-781, § 202, 76 Stat. 780, 793. In Wyeth v. Levine,

the Supreme Court described this provision as a “saving clause” and observed that “when Congress enacted an express

pre-emption for medical devices in 1976, it declined to enact such a provision for prescription drugs.” 555 U.S. 555,

567 (2009) (citations omitted)).

221 Mut. Pharm. Co. v. Bartlett, 570 U.S. 472, 492 (2013).

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In Wyeth v. Levine, the Court held that certain state claims that sought to strengthen the warnings

of a brand-name prescription drug were not preempted as long as there was no “clear evidence”

that FDA would deny approval of the warnings sought.222 Because the brand manufacturer was

allowed under FDA regulations to add warnings without obtaining FDA approval, the Court

reasoned, it may have been possible for the manufacturer to comply with both federal law and a

state-law duty to strengthen warnings, so long there was not any “clear evidence that the FDA

would not have approved” the change to the drug’s label.223 Complying with a state-law duty to

strengthen warnings also would not have obstructed the “purposes and objectives of federal drug

labeling regulation.”224 Congress, the Court observed, chose not to “provide a federal remedy for

consumers harmed by unsafe or ineffective drugs in the 1938 statute or in any subsequent

amendment.”225 This choice, the Court reasoned, supported the application of the presumption

against preemption and reflected Congress’s “determin[ation] that widely available state rights of

action provided appropriate relief for injured consumers” and perhaps the “recogni[tion] [that]

state-law remedies further consumer protection by motivating manufacturers to produce safe and

effective drugs and to give adequate warnings.”226 More recently, in Merck Sharp & Dohme Corp.

v. Albrecht, the Court clarified that “clear evidence” that FDA would have denied approval of

warnings sought “is evidence that shows the court that the drug manufacturer fully informed the

FDA of the justifications for the warning required by state law and that the FDA, in turn,

informed the drug manufacturer that the FDA would not approve a change to the drug's label to

include that warning.”227

In PLIVA v. Mensing228 and Mutual Pharmaceutical v. Bartlett,229 the Supreme Court held that

similar state claims seeking to strengthen the warnings of generic prescription drugs were

preempted. Unlike brand manufacturers who were permitted to add warnings, the Court observed

that relevant FDA regulations prohibited the defendant generic manufacturers from

“independently changing” a generic drug’s label, which must be the same as the reference listed

drug.230 Accordingly, the Court concluded—without referencing the presumption against

preemption—that it was impossible for the generic manufacturers to both comply with a state tort

duty “to change the label” while simultaneously adhering to their “federal-law duty to keep the

label the same.”231 This conflict, the Court held, was not diminished by the fact that the generic

manufacturer could ask FDA for assistance in changing the corresponding brand-name label.232 In

Bartlett, the Court further rejected the argument that a generic manufacturer could avoid the

conflict by choosing to “stop selling” its product, reasoning that “if the option of ceasing to act

defeated a claim of impossibility, impossibility pre-emption would be ‘all but meaningless.’”233

222 Wyeth v. Levine, 555 U.S. 555, 573–75 (2009).

223 See id. at 568–571.

224 Id. at 573.

225 Id. at 574.

226 Id. at 574–75.

227 587 U.S. 299, 303 (2019).

228 564 U.S. 604 (2011).

229 570 U.S. 472 (2013).

230 Mensing, 564 U.S. at 617; see also Bartlett, 570 U.S. at 484–86 (concluding that the plaintiffs’ design defect claim

amounted to a claim seeking to strengthen the warnings for the generic drug at issue, and stating that under Mensing,

“federal law prevents generic drug manufacturers from changing their labels”).

231

Mensing, 564 U.S. at 618; see also Bartlett, 570 U.S. at 484–86.

232 Mensing, 564 U.S. at 619.

233 Bartlett, 570 U.S. at 488 (quoting Mensing, 564 U.S. at 621).

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Applying Levine, Mensing, and Bartlett, lower courts have also considered whether and to what

extent the FD&C Act’s premarket approval scheme for prescription drugs preempts state claims

alleging that a drug had been defectively designed. In general, courts that have considered design

defect claims with respect to generic drugs have held that such claims were preempted under

Mensing and Bartlett.234 These courts reasoned that because a generic drug must be “identical in

active ingredients, safety, and efficacy” as its reference listed drug, the federal duty of “sameness”

made it impossible for a generic manufacturer to simultaneously comply with a state-law duty to

change a drug’s design.235

Whether design-defect claims against brand manufacturers are preempted is less settled. Lower

courts have generally agreed that a state-law claim was preempted if it sought to impose a duty on

a brand manufacturer to adopt, post-FDA approval, an alternative design for a drug.236 Such a

state-law duty, in the courts’ view, “clearly” conflicted with federal law since FDA regulations

prohibited a manufacturer from making any major changes to the “‘qualitative or quantitative

formulation of the drug product, including active ingredients, or in the specifications provided in

the approved application.’”237 Courts, however, have disagreed over whether the FD&C Act

preempted state claims alleging that relevant state law imposed a duty on a brand manufacturer to

adopt a safer alternative design before seeking FDA approval.238 Under this theory, the plaintiffs

argued, the state claim was not preempted because “there is no federal law that would have

prohibited [the brand manufacturers] from designing a different drug in the first instance.”239

In Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., the U.S. Court of Appeals for the Sixth

Circuit held that a claim based on a brand manufacturer’s pre-approval duty to adopt alternative

design was preempted because the claim was premised on a state-law duty that was too

speculative, requiring a court to assume that the alternative design would have been approved by

FDA.240 Absent a basis for such an assumption, the court concluded that it was “unable to

conceive of any coherent pre-approval duty that [the manufacturers] would have owed to [the

plaintiff] when it was developing [the drug],” leaving the post-approval duty as the only viable

duty, but one that is preempted by FDA regulations restricting major design changes.241

Since Yates, some district courts in other circuits confronting similar claims have disagreed.

These courts observe that under Yates, an injured plaintiff “can never bring a defective design

claim against a [brand] drug manufacturer.”242 This result, in these courts’ view, is inconsistent

with Levine, which recognized that Congress “determined that widely available state rights of

action provided appropriate relief for injured consumers”243 and indicated that “FDA is not the

be-all-end-all in drug regulations.”244 Congress, in these courts’ view, did not intend to shield

234 See, e.g., Hernandez v. Aurobindo Pharma USA, Inc., 582 F. Supp. 3d 1192, 1208–09 (M.D. Fla. 2022); In re

Pamidronate Prods. Liab. Litig., 842 F. Supp. 2d 479, 484 (E.D.N.Y. 2012) (listing cases).

235 See In re Pamidronate, 842 F. Supp. 2d at 484.

236 See, e.g., Guidry v. Janssen Pharms, Inc., 206 F. Supp. 3d 1187, 1206 (E.D. La. 2016).

237 See id. (quoting Bartlett, 570 U.S. at 477).

238 Yates v. Ortho-McNeil-Janssen Pharms, Inc., 808 F.3d 281, 299 (6th Cir. 2015).

239 Id.

240 Id. at 300.

241 See id.

242 See, e g., Guidry, 206 F. Supp. 3d at 1206; In re Tepezza Mktg., Sales Pracs. & Prods. Liab. Litig., No. 23 C 3568,

2023 WL 7281665, at *2 (N.D. Ill. Nov. 3, 2023) (citing cases).

243 Guidry, 206 F. Supp. 3d at 1207 (internal quotations omitted) (citing Levine, 55 U.S. at 574).

244 Id.

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brand manufacturers from liability “if their drug causes harm due to a defect in design simply

because the FDA said the drug was safe.”245

Case Law on the Preemptive Scope of Other FD&C Act Prescription Drug Requirements

Other than state tort law claims, a few courts have also considered whether and to what extent the

FD&C Act’s prescription drug requirements preempt state requirements imposed by state

legislatures or agencies.

In Ouellette v. Mills, a district court considered a challenge filed by Maine pharmacists against

provisions of a Maine statute that waived certain pharmacy licensure requirements and authorized

state residents to receive mail-order prescription drugs for personal use from licensed retail

pharmacies located in Canada, the United Kingdom, Australia, or New Zealand.246 Ruling in

favor of the pharmacists, the court held that the Maine statute was preempted because it was

“contrary to clear Congressional intent to occupy the field of pharmaceutical importation.”247

In applying field preemption principles, the Ouellette court concluded—based on legislative

history of the state law stating that it was intended to provide residents access to cheaper

prescriptions—that the relevant field of regulation was not the field of pharmacist licensure, but

the field of “importation of foreign pharmaceuticals.”248 Congress, the court observed, had

created a complex regulatory scheme covering the importation of pharmaceuticals into the United

States under the FD&C Act and has legislated explicitly with respect to the importation of drugs

from Canada under FD&C Act section 804.249 In the court’s view, these actions evidenced an

intent by Congress for the FD&C Act to “occup[y] the field of importation of pharmaceuticals

from foreign countries.”250 By singling out certain countries from which prescription drugs may

be imported, the court concluded, the state law “compromises the tightly regulated structure set

up by the [FD&C Act] and the federal government’s ability to ‘speak with one voice’ when it

regulates foreign commerce.”251

In addition to importation, several courts have also considered whether state laws that restrict

access to certain FDA-approved drugs are preempted. In Zogenix, Inc. v. Patrick, a district court

examined a Massachusetts emergency order, issued during the opioid crisis, that generally barred

the prescribing and dispensing of a then-newly-FDA-approved opioid medication based on

concerns about diversion, overdose, and abuse.252 Applying obstacle preemption principles, the

district court issued a preliminary injunction against the implementation of the order, holding that

the order was preempted by the FD&C Act.253 In the court’s view, Massachusetts’s ban on the

drug was an “obstruction” that undermined FDA’s authority to make “drugs available to promote

and protect the public health.”254 When the state later imposed certain prescribing and dispensing

restrictions on the opioid medication short of a ban, the district court conducted a fact-specific

analysis to consider the impact of the restrictions and whether they amounted to a de facto ban on

245 Id.

246 91 F. Supp. 3d 1, 4 (D. Me. 2015).

247 Id. at 12.

248 Id. at 9.

249 Id. at 10.

250 Id. at 10.

251 Id. at 10–11. (quoting Japan Line, Ltd. v. Los Angeles County, 441 U.S. 434, 499 (1979)).

252

No. 14-11689, 2014 WL 1454696, at *1 (D. Mass. Apr. 15, 2014).

253 Id. at *2.

254 Id.

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the medication.255 The court preliminarily enjoined certain prescribing restrictions because they

“would severely frustrate [the medication’s] availability,” but declined to enjoin other dispensing

restrictions because the record did not sufficiently show that the restrictions would cause

pharmacies not to carry the drug.256

Several courts have also considered whether the FD&C Act preempts state restrictions on

medication abortion. Following the Supreme Court’s decision in Dobbs v. Jackson Women's

Health Organization, which overruled Roe v. Wade and held that the U.S. Constitution does not

confer a right to an abortion,257 numerous states enacted laws aimed at restricting access to

abortion, including medication abortion.258 Mifepristone, a drug used in medication abortion, was

approved by FDA and subject to a REMS that imposes certain controls over the drug’s

distribution.259 The most recent REMS, updated in 2023, requires health care professionals who

prescribe the drug to be certified; meet specified qualifications (e.g., the ability to assess the

duration of a pregnancy accurately); and ensure that patients receive and sign a patient agreement

form relating to mifepristone use.260 This version eliminated a prior REMS control that required

an in-person office visit to health care providers in specified health care settings,261 allowing

patients to obtain the drug through the mail from certified prescribers or pharmacies.262

Lower courts in at least two cases have considered challenges that certain state laws limiting

access to medication abortion are preempted by FDA’s regulatory controls for mifepristone. In

Bryant v. Stein, the court considered a physician’s challenge against North Carolina’s medication

abortion regulations, which included numerous requirements, including an in-person 72-hour

advance consultation to review the consent form; use of an ultrasound; blood-type testing;

prescription by physicians only; in-person prescribing, dispensing, and administering; and

scheduling of an in-person follow-up appointment.263 After closely examining the evolution of

FDA’s REMS requirements for mifepristone and the nature of the state requirements, the court

concluded that some of the state requirements—such as physician-only prescription; in-person

prescribing, dispensing, and administering; and an in-person follow-up appointment—“impose[d]

safety restrictions on the distribution of [mifepristone]” that FDA had “expressly considered and

rejected.”264 Accordingly, those state requirements, in the court’s view, “stand as an obstacle to

the congressional objective of providing a comprehensive regulatory system for the use and

distribution of higher-risk drugs under the direction and supervision of the FDA.”265 However, the

court held that other state requirements—such as the in-person advance consultation, ultrasound,

255 Zogenix, No. 14-11689, 2014 WL 3339610, at *4 (D. Mass. July 8, 2014), vacated in part, No. 14-11689, 2014 WL

4273251 (D. Mass. Aug. 28, 2014).

256 Id. at *5. The district court later lifted the preliminary injunction on the prescribing restrictions after the state

modified the restrictions to be consistent with the relevant FDA-approved label. See Zogenix, 2014 WL 4273251, at *3.

257 Dobbs v. Jackson Women’s Health org., 597 U.S. 215, 231 (2022).

258 See The Availability and Use of Medication Abortion, KFF (Mar. 10, 2025), https://www.kff.org/womens-healthpolicy/fact-sheet/the-availability-and-use-of-medication-abortion/ [https://perma.cc/8PL4-P3C2].

259 See FDA, RISK EVALUATION AND MITIGATION STRATEGY (REMS): SINGLE SHARED SYSTEM FOR MIFEPRISTONE 200

MG (2023) [hereinafter 2023 MIFEPRISTONE REMS],

https://www.accessdata.fda.gov/drugsatfda_docs/rems/Mifepristone_2023_01_03_REMS_Full.pdf

[https://perma.cc/YJ4C-V9GH].

260 See id.

261 See FDA, RISK EVALUATION AND MITIGATION STRATEGY (REMS) (2016),

https://www.fda.gov/media/164649/download [https://perma.cc/3LZA-X4JK].

262 See 2023 MIFEPRISTONE REMS, supra note 259.

263

732 F. Supp. 3d 485, 502, 505 (M.D.N.C. 2024).

264 Id. at 490, 505–09.

265 Id. at 505–09.

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and blood-type testing requirements—were not preempted because they concerned regulation of

“general patient health and safety, informed consent to the termination of pregnancy, and

regulation of the medical profession,” which pertained to issues that were “beyond regulating the

safe use of mifepristone.”266

In GenBioPro v. Sorsaia, a manufacturer of generic mifepristone challenged certain West Virginia

laws that generally prohibit abortion (including access to mifepristone) except under limited

circumstances and bar health care providers from prescribing medication abortion drugs via

telemedicine.267 Affirming the district court, the U.S. Court of Appeals for the Fourth Circuit

(Fourth Circuit), after first determining that the presumption against preemption applied, held that

West Virginia’s abortion ban as applied to mifepristone use was not preempted by FDA actions

that authorized and regulated the sale of the drug.268 In authorizing FDA “to establish minimum

safety rules for administering drugs like mifepristone where they may be legally prescribed,” the

Fourth Circuit reasoned, the FD&C Act’s REMS provision “did not create a right to utilize any

particular high-risk drug.”269 Because the REMS provision did not reflect an intent “to guarantee

nationwide access to mifepristone,” it was not impossible for the manufacturer to comply with

both FDA regulations and the state ban, nor [did] the state ban pose an obstacle to the REMS

provision’s goal of ensuring drug access.270 The appellate court, however, also noted that the

district court’s conclusion with respect to the state’s separate telemedicine restriction was not at

issue in the appeal.271 With respect to the state telemedicine restrictions on mifepristone, the

district court held that the restriction was “unambiguously preempted by the 2023 REMS,” which

“reflects a determination by the FDA that when mifepristone is prescribed, it may be prescribed

via telemedicine.”272 The state telemedicine restrictions, the courts reasoned, made it impossible

for a licensed medical professional prescribing mifepristone to comply “with both the access

determination made by the FDA and the access determination made by West Virginia as to

telehealth.”273

Medical Devices

Overview of Selected FD&C Act Provisions on Medical Devices

In addition to drugs, the original 1938 FD&C Act also subjected medical devices to FDA

regulation. Unlike for new drugs, however, the 1938 law did not authorize FDA to conduct

premarket review of new medical devices.274 Instead, FDA’s authority over medical devices was

primarily limited to seizing or obtaining an injunction against medical devices that were

misbranded or adulterated, after the devices were already on the market.275 FDA began to focus

its regulatory efforts on medical devices around the 1960s, after developments in the relevant

industries—including electronics, plastics, and design engineering—led to the invention of

266 Id. at 502–03.

267 No. 3:23-0058, 2023 WL 5490179, at *1–2 (S.D.W.Va. Aug. 24, 2023), aff’d sub nom., GenBioPro, Inc. v. Raynes,

144 F.4th 258 (4th Cir. 2025).

268 Raynes, 144 F.4th at 273, 275–77.

269 Id. at 276.

270 Id. at 275–76.

271 Id. at 268 n.1.

272 Sorsaia, 2023 WL 5490179 at *10.

273

Id. at *11.

274 See ch. 675, §§ 501–505, 52 Stat. 1040, 1049–53 (1938).

275 See id.

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sophisticated devices—such as heart pacemakers, defibrillators, and surgical implants—used to

address critical medical conditions.276 After several high-profile reports of safety concerns in the

early 1970s related to various devices, including the Dalkon Shield, several cardiac pacemakers,

and certain intraocular lenses,277 Congress enacted the Medical Device Amendments of 1976

(MDA).278

The MDA amended the FD&C Act to establish a regulatory regime that oversees medical devices

based on the risk posed to the consumer. Specifically, the MDA, as amended, established three

classes of devices based on the degree of regulatory control needed to provide assurance of a

device’s safety and effectiveness. Class I medical devices, considered low risk, are subject to

general controls that include manufacturer registration and listing of manufactured devices.279

Class II devices, considered moderate risk, are subject to general controls as well as certain

“special controls” deemed necessary by FDA to reduce or mitigate risk.280 Special controls may

include, for instance, special labeling requirements, mandatory performance, and post-market

surveillance.281 Class III devices are considered the highest risk, because the devices are used to

support or sustain human life, are important in preventing impairment of human health, or

present a potential, unreasonable risk of illness or injury.282 Class III devices, with certain

exceptions, are subject to general controls and premarket approval (PMA) by FDA before they

can be lawfully marketed.283

The PMA process is the most stringent approval pathway that FDA can require.284 Under this

process, an applicant must submit a PMA application that includes, among other things,

information regarding proposed labeling, foreign and U.S. marketing history, summary of clinical

and nonclinical studies, conclusions drawn from such studies, and information regarding the

components, ingredients, and operating principles of the device.285 After a device has received

premarket approval, the manufacturer generally cannot make, without FDA approval, changes to

the device—including changes in labeling, indication, performance, or design specifications—

that would affect the device’s safety or effectiveness.286

The most commonly used premarket approval pathway for medical devices, however, is the

premarket notification pathway, commonly referred to as the 510(k) clearance.287 Under this

pathway, through which most Class II devices are made available,288 a device manufacturer must

submit a 510(k) notification at least 90 days prior to marketing the device.289 The submission

276 HUTT ET AL., supra note 16, at 1597.

277 Id. at 1597–98.

278 Pub. L. No. 94-295, 90 Stat. 539 (1976).

279 21 U.S.C. § 360c(a)(1)(A).

280 Id. § 360c(a)(1)(B).

281 Id.

282 Id. § 360c(a)(1)(C)(ii).

283 Id. § 360e(c)(1).

284 See U.S. FOOD & DRUG ADMIN., Premarket Approval (PMA) (May 16, 2019), https://www.fda.gov/medical-

devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma

[https://perma.cc/3QAP-YQGS] (“PMA is the most stringent type of device marketing application required by FDA.”).

285 Id.

286 Id. § 360e(d)(5); 21 C.F.R. § 814.39 (2025).

287 See CRS Report R47374, FDA Regulation of Medical Devices, by Amanda K. Sarata, at 8 (2023). The reference to

“510(k)” refers to the FD&C Act section that imposes the premarket notification requirement.

288 See id.

289 21 U.S.C. §§ 360(k), (n)(1).

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must demonstrate that the device proposed to be marketed is substantially equivalent to a certain

device already on the market (i.e., a predicate device).290 A device is “substantially equivalent” to

a predicate device if it has (1) the same intended use and the same technological characteristics as

the predicate device, or (2) the same intended use, different technological characteristics, and

information and data that demonstrate safety and effectiveness, and does not “raise different

questions of safety and effectiveness than the predicate device.”291 So unlike a PMA application,

which must include safety and efficacy data concerning the device at issue, a 510(k) submission

is focused instead on information comparing the device at issue to a predicate device.292

FD&C Act Section 521: Preemption Provision Related to Medical Devices

When Congress enacted the MDA in 1976, at least 13 states had specific statutes or rules

regulating medical devices.293 To define the federal and state roles in regulating medical devices,

the MDA added an express preemption provision at FD&C Act section 521.294 Subsection (a) of

the provision states the following:

[N]o State or political subdivision of a State may establish or continue in effect with respect

to a device intended for human use any requirement—

(1) which is different from, or in addition to, any requirement applicable under this chapter

to the device, and

(2) which relates to the safety or effectiveness of the device or to any other matter included

in a requirement applicable to the device under this chapter.295

Subsection (b) carves out an exception to the scope of preemption under subsection (a). Under

subsection (b), FDA may, upon application by a state or its political subdivision, exempt state or

local device requirements that are either (1) “more stringent” than federal ones; or (2) “required

by compelling local conditions” and where “compliance with the requirement would not cause

the device to be in violation of any applicable requirement” under the FD&C Act.296 FDA’s

implementing regulations related to section 521 also provide that the provision does not extend to

“[s]tate or local requirements of general applicability [whose] purpose . . . relates either to other

products in addition to devices.”297

Courts have evaluated the scope of MDA’s express preemption provision on numerous occasions,

primarily in the context of considering whether and to what extent the provision preempts state

tort law claims alleging manufacturing, design, and/or warning defects related to certain medical

devices. In the context of hearing aids, courts have also considered the extent to which the

provision preempts state-enacted device requirements.

290 See 21 U.S.C. § 21 U.S.C. §§ 360c(f)(1)(A)(ii), 360e(b), (i); 21 C.F.R. § 807.92 (2025). A predicate device may be

(1) a device that was legally marketed prior to May 28, 1976; (2) a device which has been reclassified from class III to

class II or I; or (3) a device cleared through the 510(k) notification process. 21 C.F.R. § 807.92(a)(3) (2025).

291 21 U.S.C. § 360c(i)(1)(A).

292 See id.

293 HUTT ET AL., supra note 16, at 1597.

294 21 U.S.C. § 360k.

295 Id. § 360k(a).

296

Id. § 360k(b).

297 21 C.F.R. § 808.1. The regulation provides examples of these state requirements, including general electrical codes,

the Uniform Commercial Code, and unfair trade practices in which the requirements are not limited to devices. See id.

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Case Law on the Preemptive Scope of FD&C Act Section 521 on State Tort Law

Claims

The Supreme Court has twice considered the scope of the MDA preemption provision (FD&C

Act section 521) as applied to state tort law claims, in Medtronic v. Lohr298 and Riegel v.

Medtronic.299 In these cases, the Supreme Court generally held that the extent to which section

521 preempts state claims depends in part on how that device received marketing approval from

FDA. The Court’s reasoning in these cases indicates that the preemptive scope of section 521 is

broadest for devices approved through the PMA process, the most rigorous approval pathway,

limiting the types of claims a plaintiff may assert based on alleged injuries resulting from the use

of such devices.300 The preemptive scope of section 521 for devices cleared through 510(k)

notification, on the other hand, is narrower.301

In Lohr, the Supreme Court considered the preemptive scope of section 521 as applied to state

claims alleging manufacturing, design, and labeling defects regarding a pacemaker that was

cleared for marketing under the 510(k) notification process.302 A majority of the Court agreed that

section 521 did not preempt these particular state tort claims, but no majority of Justices agreed

on the extent to which the provision preempts state-law tort actions in general.303

In Lohr, the plaintiffs sued a pacemaker manufacturer after a component of the device, implanted

in one of the plaintiffs, allegedly failed and caused her to suffer a heart block requiring

emergency surgery.304 The plaintiffs asserted various tort claims alleging that the pacemaker was

defectively designed and manufactured, and that the manufacturer failed to provide adequate

warnings and labels regarding the risk of the device.305 According to the Court, analyzing the

preemptive scope of section 521 “require[s] a careful comparison between the allegedly preempting federal requirement and the allegedly pre-empted state requirement to determine whether

they fall within the intended pre-emptive scope of the statute and regulations.”306

The Court held that section 521 did not preempt the plaintiffs’ defective design claims because

the 510(k) clearance process does not impose federal design requirements related to the “safety”

and “effectiveness” of the device.307 Because the 510(k) process merely established that the

pacemaker was “substantially equivalent” to a device already on the market, the Court reasoned,

FDA “did not ‘require’ [defendant’s] pacemaker to take any particular form for any particular

reason,” nor did the agency “formally review[]” the device “for safety or efficacy.”308 The Court

similarly held that the plaintiffs’ manufacturing and labeling/warning defect claims were not

preempted.309 In the Court’s view, “the allegedly pre-empting federal requirement” at issue—

certain labeling and “Good Manufacturing Practices” requirements set forth in FDA regulations

298 518 U.S. 470 (1996).

299 552 U.S. 312 (2008).

300 See Riegel, 522 U.S. at 320–21.

301 See Lohr, 518 U.S. at 493, 498–99.

302 Id. at 492–501, 502

303 See id. at 508 (Breyer J., concurring in judgment); id. at 512–13 (O’Connor, J., concurring in part, dissenting in

part).

304 Id. at 480–81.

305 See id. at 481, 492.

306 Id. at 500.

307

Id. at 493.

308 Id.

309 Id. at 498–99.

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that are generally applicable to devices and their manufacturers—were not sufficiently specific to

the pacemaker to constitute federal requirements “applicable to the device” under section 521 to

have preemptive force.310

While a majority of Justices in Lohr agreed that the plaintiffs’ state-law tort claims were not

preempted under section 521, a different majority of Justices also expressly indicated that “the

MDA will sometimes preempt a state-law tort suit.”311 This open question regarding the

circumstances under which state-law tort claims are preempted led to continued litigation in the

lower courts.

In Riegel v. Medtronic, the Supreme Court resolved some aspects of the open questions when it

held that certain state-law tort claims based on alleged injuries related to a medical device

approved through the PMA process were preempted under section 521. In Riegel, the plaintiffs

sued a catheter manufacturer after the catheter, used in a coronary angioplasty procedure for one

of the plaintiffs, ruptured during the procedure and caused the patient to develop a heart block,

requiring emergency coronary bypass surgery.312 The plaintiffs alleged that the catheter was

defectively designed, labeled, and manufactured in a manner that violated applicable state

common law.313 Siding with the defendant, the Court affirmed the dismissal of the plaintiffs’

claims as preempted.314

In reaching this conclusion, the Court first concluded that the PMA process—unlike the 510(k)

notification process and the generally applicable labeling and manufacturing requirements at

issue in Lohr—imposes device-specific federal requirements.315 Unlike the 510(k) notification

process—which focuses on a device’s substantial equivalence to an already marketed device and

does not require a device to “take any particular form for any particular reason”—the PMA

process, the Court observed, “is federal safety review.”316 Under the PMA process, an approved

device must “be made with almost no deviations from the specifications in its approval

application, for the reason that the FDA has determined that the approved form provides a

reasonable assurance of safety and effectiveness.”317 The Court then held that a state’s

“requirements” subject to preemption under section 521 “include[] its common-law duties.”318 In

so concluding, the Court rejected the plaintiffs’ argument that section 521 “exclud[es] commonlaw duties from the scope of pre-emption” and preempts only state regulatory law or state

requirements specific to the device.319 Accordingly, because the plaintiffs asserted that the

catheter device “violated state tort law notwithstanding compliance with the relevant federal

requirements”—such that the applicable common law duties imposed requirements beyond

federal requirements—the Court held that their state claims were preempted.320

310 Id.

311 See id. at 503 (Breyer, J., concurring in part and in the judgment); see also 518 U.S. at 512–13 (O’Connor, J.,

concurring in part, dissenting in part) (agreeing that plaintiffs’ design defect claims were not preempted, but concluding

that some or all of plaintiffs’ manufacturing and labeling claims would be preempted if they “would compel [the

defendant] to comply with requirements different from, or in addition to, those required by the FDA”).

312 Riegel v. Medtronic, Inc., 552 U.S. 312, 320 (2008).

313 Id. at 320.

314 See id. at 321, 330.

315 See id. at 323.

316 Id.

317 Id.

318

Id. at 324.

319 See id. at 324–25, 327–28.

320 See id. at 330.

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At the same time, the Court acknowledged that section 521 does not preempt all state claims

related to a device approved under the PMA process.321 Specifically, the Court observed that even

if state common-law duties impose relevant state safety and efficacy “requirements,” they are

preempted under section 521 “only to the extent that they are ‘different from, or in addition to’

the requirements imposed by federal law.”322 In other words, state requirements that “parallel”

federal requirements are not preempted.323 In Riegel, however, the Court observed that because

the plaintiffs did not argue that they had asserted parallel state claims, it declined to consider, in

the first instance, whether the plaintiffs had raised parallel claims, and affirmed the dismissal of

their claims.324

Following Riegel, lower courts have generally concluded that for devices approved through the

PMA process, Riegel, combined with the Court’s decision in Buckman,325 leave a “‘narrow gap’

through which a state-law claim must fit to escape preemption by the [FD&C Act].”326 In general,

lower courts have held that state-law claims related to PMA-approved devices avoid preemption

only if they rest on a state-law duty that parallels a federal-law duty.327 As a practical matter, this

means that many design or manufacturing defect claims—to the extent that they assert that a

PMA-approved device should have been designed or manufactured differently from the

specifications FDA had approved—are preempted.328 Some parallel state claims, however, have

been found to escape preemption. For example, several courts have concluded that certain statelaw failure-to-warn claims were not preempted to the extent that they alleged that a defendant

failed to report serious injuries and malfunctions of the device as required by both applicable

FDA regulations and applicable state tort law duty to provide “adequate warnings or

instructions.”329

Case Law on the Preemptive Scope of FD&C Act Section 521 on State DeviceSpecific Requirements

In addition to cases that considered the preemptive scope of FD&C Act section 521 as applied to

state tort claims, several lower courts have also considered section 521 as applied to devicespecific requirements enacted by states, particularly with respect to hearing aids.330

321 See id.

322 Id. (quoting 21 U.S.C. § 360k(a)(1)).

323 See id. (stating that section 521 “does not prevent a State from providing a damages remedy for claims premised on

a violation of FDA regulations; the state duties in such a case ‘parallel,’ rather than add to, federal requirements”

(quoting Lohr, 518 U.S. at 495)).

324 Id.

325 See supra “Preemption Based on the FD&C Act’s Enforcement Scheme.”

326 Perez v. Nidek, 711 F.3d 1109, 1120 (9th Cir. 2013) (quoting In re Medtronic, Inc., Sprint Fidelis Leads Prods.

Liab. Litig., 623 F.3d 1200, 1204 (8th Cir. 2010); see also Hughes v. Boston Sci. Corp., 631 F.3d 762, 768 (5th Cir.

2011) (“[W]e must ask whether the state law at issue creates a requirement that is related to the device’s safety or

effectiveness and is ‘different from or in addition to’ a federal requirement.” (quoting 21 U.S.C. § 360k(a))).

327 See, e.g., Stengel v. Medtronic Inc., 704 F.3d 1224, 1233 (9th Cir. 2013).

328 See, e.g., Hughes, 631 F.3d at 768 (“It is clear that all of Hughes’s state products liability claims that purport to

impose liability on Boston Scientific despite Boston Scientific’s compliance with the applicable FDA design and

manufacturing specifications, as approved by the FDA during the PMA process, seek to impose different or additional

state duties and are expressly preempted.”).

329 See, e.g., id. at 769; Stengel, 704 F.3d at 1233.

330 FDA regulations governing hearing aids changed significantly after the agency, pursuant to section 709 of the FDA

Reauthorization Act of 2017, Pub. L. No. 115-52, 131 Stat. 1005, established an over-the-counter category of hearing

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At least one state, for example, had sought to invoke the preemption exemption process under

section 521(b) for the state’s hearing aid requirements. Specifically, in 1978, Massachusetts

enacted a state law regulating the sale of hearings aids in that state.331 The state requirements

were more stringent than the then-applicable FDA hearing-aid regulations in two respects: (1) the

state law required all consumers—with the exception of those with a religious waiver—to obtain

a medical evaluation from a physician before purchasing a hearing aid, while FDA regulations

generally permitted adults who had been provided with specified warnings to waive the medical

evaluation requirement; and (2) the state law, unlike the FDA regulations, also required a “hearing

test evaluation” by a physician or audiologist.332 After FDA denied Massachusetts’s application

for exemption following a public hearing and receipt of comments, the state sued to challenge the

denial.333 The U.S. Court of Appeals for the First Circuit, in Massachusetts v. Hayes, upheld

FDA’s denial of exemption.334 In doing so, the court rejected the state’s argument that section

521(b) required FDA to grant an exemption “whenever state regulations are ‘more stringent’ and

do not unduly burden interstate commerce.”335 In the court’s view, FDA’s “statutory authority to

grant exemption from preemption is plainly discretionary.”336 The court further concluded that

FDA’s denial of exemption was not arbitrary and capricious, given the agency’s review of

evidence related to the predictive value of audiological testing and its conclusion that

“audiological evaluation is not necessary to provide reasonable assurance of the safety or

effectiveness of hearing aids.”337

For state hearing aid requirements not subject to exemption from preemption, several courts have

considered the extent to which they were preempted by section 521(a). Several courts have held,

for instance, that state laws which required hearing aid purchasers to undergo presale “fitting and

testing” services by specified licensed professionals were preempted by then-applicable federal

regulations.338 In the courts’ view, because applicable federal regulations generally required

purchasers to undergo an auditory evaluation or provide a signed waiver, an auditory examination

was effectively optional; thus, a state law requiring presale fitting and testing imposed a safety

and efficacy requirement “in addition to” federal requirements and was preempted.339 In contrast,

aids. The FDA hearing aid regulations referenced in the cases discussed in this section are no longer in effect, but the

courts’ analysis of those regulations relative to applicable state requirements illustrates how courts approach the

preemption analysis involving state device-specific requirements.

331 See Massachusetts v. Hayes, 691 F.2d 57, 59 (1st Cir. 1982) (discussing MASS. GEN. LAWS ch. 93, §§ 72–74).

332 Id. at 59. As discussed in note 330 supra, the federal hearing aid regulations referenced in Hayes and other cases

discussed in this section are no longer in effect.

333 Id. at 59.

334 Id.

335 691 F.2d at 61.

336 Id. at 60.

337 Id. at 63. (quoting Exemption from Preemption of State and Local Hearing ALD Requirements; Applications for

Exemption, 45 Fed. Reg. 67326, 67329 (Oct. 10, 1980)).

338 See, e.g., Mo. Bd. of Exam’rs for Hearing Instrument Specialists v. Hearing Help Express, Inc., 447 F.3d 1033,

1036–37 (8th Cir. 2006) (holding that a Missouri statute that prohibited mail order sales of hearing aids “without prior

fitting and testing by a hearing instrument specialist” was preempted by applicable federal regulations); METX, LLC v.

Wal-Mart Stores Tex., LLC, 62 F. Supp. 3d 569, 582, 584 (E.D. Tex. 2014) (interpreting certain Texas licensure

regulations to require a “fitter and dispenser” of hearing aids to “perform a pre-sale non-waivable ‘audiological

evaluation’” and holding that such a requirement imposed an additional safety and efficacy requirement applicable to

hearing aids and was thus expressly preempted by federal law).

339 See, e.g., Mo. Bd. of Exam’rs, 447 F.3d at 1036–37; METX, LLC, 62 F. Supp. 3d at 582, 584. But see Smith v.

Pingree, 651 F.2d 1021, 1023–24 (5th Cir. 1981) (holding that a Florida law requiring a hearing aid dispenser to

conduct, in a certified testing room, a presale “hearing test to determine the degree and type of hearing deficiency” was

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another court held that a state’s general licensure requirements for hearing aid dispensers, which

were not tied to the state’s separate pre-sale testing requirements, were not expressly preempted

by section 521(a).340

Cosmetics

Overview of Selected FD&C Act Provisions on Cosmetics

The FD&C Act, since its initial enactment in 1938, prohibits the marketing of adulterated or

misbranded cosmetics (i.e., cosmetics that are unsafe or mislabeled).341 A cosmetic is deemed

adulterated, for instance, if it contains any substances that are poisonous, putrid, or unsanitary, or

otherwise contain a “substance which may render it injurious to users.”342 A cosmetic is deemed

misbranded, for instance, if its “labeling is false or misleading in any particular.”343 In 1966,

Congress enacted the Fair Packaging and Labeling Act (FPLA), which authorized FDA to issue

regulations governing the labeling and packaging of many cosmetic products.344 In 1970,

Congress additionally enacted the Poison Prevention Packaging Act of 1970 (PPPA) to require

special packaging to protect children from injury or illness from handling or ingesting household

substances, including cosmetics.345 Cosmetic products that do not comply with FPLA and PPPA

requirements are deemed misbranded under the FD&C Act.346 These authorities governing

cosmetics, which generally do not need to undergo premarket review,347 remained largely

unchanged until Congress enacted the Modernization of Cosmetics Regulation Act of 2022

(MoCRA).348 MoCRA expanded FDA’s regulatory authority over cosmetics in several respects.

While cosmetic products generally still are not subject to premarket review, MoCRA requires

cosmetics manufacturers to report serious adverse events, register their facilities and list cosmetic

products with FDA, and substantiate the safety of their products.349 MoCRA also expanded the

labeling requirements for cosmetics, including requiring product labels to identify each fragrance

allergen contained in the product.350

not preempted because then applicable federal regulation did not “preclude the state from initiating minimal

requirements relating to the mechanics of fitting the hearing aid to the patient”).

340 Taylor v. Polhill, 964 F.3d 975, 982–84 (11th Cir. 2020).

341 Ch. 675, 52 Stat. 1040 (1938).

342 21 U.S.C. § 361(a), (b), (c), (d).

343 Id. § 362(a).

344 Pub. L. No. 89-755, 80 Stat. 1296 (1966) (codified as amended at 15 U.S.C. §§ 1451–1461). The FPLA applies to

the packaging and labeling of “consumer commodities,” which include cosmetics “customarily produced or distributed

for sale through retail sales agencies or instrumentalities for consumption by individuals, or use by individuals for

purposes of personal care . . . and which [are] usually . . . consumed or expended in the course of such consumption or

use.” 15 U.S.C. § 1459(a).

345 Pub. L. No. 91-601, 84 Stat. 1670 (1970). Regulations implementing the PPPA are promulgated by the Consumer

Product Safety Commission. See 16 C.F.R. §§ 1700.1–1700.20 (2025).

346 See 15 U.S.C. § 1456(a); 21 U.S.C. § 362(f).

347 The Color Additive Amendments of 1960 requires color additives included in certain FDA-regulated products,

including cosmetics, to be subject to premarket approval. See Pub. L. No. 86-618, 74 Stat. 397 (1960); 21 U.S.C.

§ 379e.

348 Pub. L. No. 117-328, §§ 3501–3508, 136 Stat. 4459, 5847 (2022) (codified as amended at 21 U.S.C. §§ 364–364j).

Additionally, over the years, some legislation has amended the FD&C Act’s provisions on cosmetics, but these changes

did not significantly alter FDA’s authority over cosmetics regulation. See, e.g., Microbead-Free Waters Act of 2015,

Pub. L. No. 114-114, 129 Stat. 3129 (2015) (codified as amended at 21 U.S.C. § 331 note).

349 21 U.S.C. § 364c.

350 Id. § 364e(b).

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FD&C Act Sections 752 and 614: Express Preemption Provisions Related to

Cosmetics

With respect to cosmetics, the FD&C Act contains two express preemption clauses that reflect

Congress’s recognition of states’ concurrent role in regulating these products. FD&C Act section

752, enacted in 1997, states the following:

[N]o State . . . may establish or continue in effect any requirement for labeling or packaging

of a cosmetic that is different from or in addition to, or that is otherwise not identical with,

a requirement specifically applicable to a particular cosmetic or class of cosmetics under

[the FD&C Act], the Poison Prevention Packaging Act of 1970 . . . , or the Fair Packaging

and Labeling Act . . . .351

At the same time, section 752(d) specifically states that this preemption clause “shall [not] be

construed to modify or otherwise affect any action or the liability of any person under the product

liability law of any State.”352 Section 752(e) further states that the section does not “apply to a

State requirement adopted by a State public initiative or referendum enacted prior to September 1,

1997.”353

In 2022, MoCRA added a second preemption clause at FD&C Act section 614. The provision

states, in relevant part, the following:

No State . . . may establish or continue in effect any law, regulation, order, or other

requirement for cosmetics that is different from or in addition to, or otherwise not identical

with, any requirement applicable under [the FD&C Act] with respect to registration and

product listing, good manufacturing practice, records, recalls, adverse event reporting, or

safety substantiation.354

Section 614 also explicitly preserves state laws in several respects. To preserve state regulation of

cosmetic ingredients, the provision clarifies that section 614 should not be “construed to prevent

any State from prohibiting the use or limiting the amount of an ingredient in a cosmetic product,”

nor should section 614 be construed to prohibit a state from continuing in effect any state

requirement that directed the reporting of a cosmetic ingredient to the state that was in effect at

the time of MoCRA’s enactment.355 In addition, section 614 includes a savings clause stating that

no MoCRA provision or any of its implementing regulations “shall be construed to modify,

preempt, or displace any action for damages or the liability of any person under the law of any

State, whether statutory or based in common law.”356

Case Law on the Preemptive Scope of FD&C Act Section 752

To date, courts that have considered the preemptive scope of the FD&C Act’s cosmetics

provisions appear to have addressed only the preemptive scope of FD&C Act section 752.357 In

351 Id. § 379s(a).

352 Id. § 379s(d).

353 Id. § 379s(e). Available legislative history indicates that this subsection was intended to preserve state laws like

California’s Safe Drinking Water and Toxic Enforcement Act of 1986 (Proposition 65). See 143 CONG. REC. 25797

(1997) (“Most importantly, this provision does nothing to affect California’s Proposition 65, an innovative state

initiative that has helped reduce Californians’ exposure to toxic hazards.”); CAL. HEALTH & SAFETY CODE §§ 25249.5–

25249.14.

354 21 U.S.C. § 364j(a).

355

Id. § 364j(b).

356 Id. § 364j(c).

357 As of the date of publication, no court appears to have addressed the preemptive scope of FD&C Act section 614.

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these cases, the plaintiffs’ claims generally involved state-law claims alleging that a cosmetic

product’s label was misleading or did not adequately warn of the risks associated with the

product.358

When considering whether these claims were preempted, courts have generally held that state-law

claims interpreted to impose labeling requirements identical to those required by the FD&C Act

were not preempted by section 752.359 For example, in Astiana v. Hain Celestial Group, the

plaintiffs brought claims under California’s unfair competition and false advertising laws and for

common law fraud alleging that a cosmetic labeled “all natural” or “pure natural” duped

consumers seeking natural products into buying products that were full of artificial and synthetic

ingredients.360 The court considered whether the state-law claims imposed a requirement that was

“different from or in addition to, or that is otherwise not identical with” a cosmetics requirement

in the FD&C Act.361 The court concluded that they did not.362 If the label stating the product was

“all natural” and “pure natural” was misleading as the plaintiffs claimed, the court reasoned, it

would also violate the FD&C Act, which prohibits cosmetic labeling that is “false or misleading

in any particular.”363 The Ninth Circuit therefore held that the plaintiffs’ claims were not

preempted because they would impose requirements identical to those imposed by the FD&C

Act.364

On the other hand, courts have concluded that certain state claims that sought to add additional

disclaimers not required by applicable federal requirements were preempted.365 In Critcher v.

L’Oreal USA, Inc., consumers who had purchased liquid cosmetic products alleged that they were

unable to dispense a portion of the product from the containers.366 They asserted state-law claims

based on allegations that they were duped “into buying more of the cosmetics than they could

use” and that the product labels should have disclosed that the products could not be fully

dispensed from their containers.367 The plaintiffs, however, conceded that the packaging complied

with federal packaging requirements and that the labels accurately stated the amount of product

contained in each package.368 The U.S. Court of Appeals for the Second Circuit held that the

plaintiffs’ claims were preempted because the FD&C Act does not impose obligations to include

358 See Astiana v. Hain Celestial Grp., Inc., 783 F.3d 753, 757 (9th Cir. 2015); Ebner, 838 F.3d at 965 (noting that the

plaintiffs asserted claims under California’s False Advertising Law, California Consumers Legal Remedies Act,

California’s Unfair Competition Law, and unjust enrichment).

359 See id.; Ebner v. Fresh, Inc., 838 F.3d 958, 965 (9th Cir. 2016) (“Because the Sherman Law does not amount to

something ‘different from or in addition to’ what federal law already requires, . . . preemption does not bar Plaintiff’s

claim.” (citation omitted) (quoting 21 U.S.C. § 379s(a))). Lower courts have also grappled with how to interpret FD&C

Act section 752’s savings clause that explicitly preserves state products liability claims. In at least one case, the court

held that the plaintiffs’ non-products-liability claims (e.g., negligent misrepresentation and breach of warranty claims)

were not preempted, to the extent they were based on the same allegations as plaintiffs’ products liability claims. See In

re Hair Relaxer Mktg., Sales Pracs. & Prods. Liab, Litig,, 702 F. Supp. 3d 692, 699–701 (N.D. Ill. 2023).

360 Astiana, 783 F.3d at 756.

361 Id. at 757 (quoting 21 U.S.C. § 379s(a)).

362 Id. at 759.

363 Id. at 757–58 (quoting 21 U.S.C. §§ 362(a), 379s).

364 Id. at 759.

365 Critcher v. L’Oreal USA, Inc., 959 F.3d 31, 33 (2d Cir. 2020).

366

Id.

367 Id.

368 Id. at 37.

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supplemental disclosures regarding the amount of accessible product, which would impose

labeling requirements “in addition to” those mandated by the FD&C Act.369

Tobacco Products

Overview of Selected FD&C Act Provisions on Tobacco Products

The original 1938 FD&C Act did not expressly authorize FDA to regulate tobacco products.

Before 1996, FDA generally took the position that it lacked jurisdiction under the FD&C Act to

regulate tobacco products.370 As evidence of tobacco manufacturers’ knowledge regarding the

health effects of their products mounted,371 however, FDA promulgated a final rule in 1996 that

would have imposed several restrictions on the sale, distribution, and advertisement of tobacco

products.372 FDA asserted that it had jurisdiction to regulate tobacco products based on its

determination “that nicotine is a ‘drug’ and that cigarettes and smokeless tobacco are ‘drug

delivery devices[.]’”373 A group of tobacco manufacturers, retailers, and advertisers sued to

challenge the rule.374 In 2000, the Supreme Court held in FDA v. Brown & Williamson Tobacco

Corp. that “[c]onsidering the [FD&C Act] as a whole, it is clear that Congress intended to exclude

tobacco products from the FDA’s jurisdiction.”375 In the Court’s view, under the FD&C Act’s

regulatory regime, “FDA may not . . . conclude that a drug or device cannot be used safely for

any therapeutic purpose and yet, at the same time, allow that product to remain on the market,”376

yet Congress had “foreclosed the removal of tobacco products from the market” in other tobaccospecific legislation.377 Given that tobacco products “cannot be used safely for any therapeutic

purpose [yet] they cannot be banned,” the Court reasoned that these products “simply d[id] not

fit” within the FD&C Act’s regulatory scheme.378

In 2009, Congress enacted the Family Smoking Prevention and Tobacco Control Act (TCA),

which amended the FD&C Act to expressly authorize FDA to regulate tobacco products as a

category separate from food, drug, devices, and cosmetics.379 The TCA establishes the central

federal regulatory regime for the manufacture, marketing, and distribution of tobacco products.380

In establishing this regulatory regime, the TCA aims to balance competing interests in protecting

369 Id.

370 See FDA v. Brown & Williamson Tobacco Corp., 529 U.S. 120, 143–44 (2000) (observing that, between 1965 and

2000, Congress had “enacted six separate pieces of legislation . . . addressing the problem of tobacco use and human

health,” and had done so “against the backdrop of the FDA’s consistent and repeated statements that it lacked authority

under the [FD&C Act] to regulate tobacco absent claims of therapeutic benefit by the manufacturer”).

371 See HUTT ET AL., supra note 16, at 1821–22.

372 Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco Products to Protect Children

and Adolescents, 60 Fed. Reg. 44396 (Aug. 28, 1996) (codified as amended at 21 C.F.R. pts. 801, 803, 804, 807, 820,

897 (2025)).

373 Brown & Williamson Tobacco Corp., 529 U.S. at 127 (quoting 60 Fed. Reg. 44396, 44397, 44402 (Aug. 28, 1996)).

374 Id. at 120.

375 Id. at 142.

376 Id. at 142.

377 Id. at 137.

378

Id. at 143.

379 Pub. L. No. 111-31, 123 Stat. 1776 (2009).

380 See, e.g., 21 U.S.C. §§ 387b, 387c, 387f, 387f-1, 387g, 387j.

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the public’s health against the harmful effects of smoking and youth tobacco use, while

preserving access to lawfully marketed tobacco products for adult consumers.381

Among other requirements, the TCA requires all new tobacco products—i.e., those not

commercially marketed in the United States prior to February 15, 2007—to receive prior

authorization from FDA before being marketed to the public.382 In particular, the TCA requires

FDA to deny an application seeking authorization for a new tobacco product if the agency finds

that “there is a lack of a showing that permitting such tobacco product to be marketed would be

appropriate for the protection of the public health.”383 In addition, the TCA, based on Congress’s

recognition that flavors can make tobacco products more appealing to youth and expose users to

additional carcinogens or other toxic constituents,384 also expressly prohibits the manufacture and

sale of cigarettes or cigarette components with flavors other than tobacco or menthol.385 The same

provision, at FD&C Act section 907(b), further authorizes FDA to adopt, through notice-andcomment rulemaking, additional tobacco product standards if the agency finds that such a

standard “is appropriate for the protection of the public health.”386 FDA may also promulgate

restrictions on the sale and distribution of a tobacco product—including restrictions on the access

to, and the advertising and promotion of, the tobacco product.387 Additionally, the TCA imposes

certain labeling requirements388 on top of those already required under then-existing federal

law.389

While the TCA explicitly applies to cigarettes, cigarette tobacco, roll-your-own tobacco, and

smokeless tobacco, the statute also authorizes FDA to deem other tobacco products subject to the

law.390 In 2016, FDA invoked this authority and promulgated what is known as the Deeming

Rule, which subjected certain electronic nicotine delivery system products—products commonly

known as e-cigarettes or vapes—to the TCA’s regulatory regime.391 Under the rule, entities

seeking to legally market their e-cigarettes that were on the market as of August 8, 2016, or any

new e-cigarette products, were generally required to submit a premarket tobacco product

application and receive marketing authorization from FDA.392

As of the date of this report, FDA has authorized a total of 45 e-cigarette products for lawful

marketing, including 35 tobacco-flavored e-cigarettes, 8 menthol-flavored e-cigarettes, and 2

fruit-flavored e-cigarettes.393 With respect to the authorized tobacco- and menthol-flavored

381 Pub. L. No. 111-31, § 3, 123 Stat. at 1781.

382 21 U.S.C. § 387j(a).

383 Id.§ 387j(c)(2).

384 See H.R. REP. NO. 111-58, pt. 1, at 4 (2009).

385 21 U.S.C. § 387g(a)(1)(A). The provision, however, also expressly preserves FDA’s authority to establish tobacco

product standards relating to menthol and other flavors. See id.

386 Id. § 387g(a)(3)(A), (b), (d).

387 Id. § 387f(d)(1).

388 See, e.g., id. § 387t(a), § 387g(a)(4)(C).

389 The Federal Cigarette Labeling and Advertising Act of 1965, Pub. L. No. 89-92, 79 Stat. 282 (1965) and the

Comprehensive Smokeless Tobacco Health Education Act of 1986, Pub. L. No. 99-252, 100 Stat. 30 (1986), as

amended, impose certain labeling requirements and advertising restrictions on cigarettes and smokeless tobacco,

respectively.

390 21 U.S.C. § 387a(b).

391 Deeming Tobacco Products To Be Subject to the Federal Food, Drug, and Cosmetic Act, 81 Fed. Reg. 28974, 28976

(May 10, 2016).

392 Id.

393 E-Cigarettes,“Vapes” and Other Electronic Nicotine Delivery Systems (ENDS) Authorized by the FDA, FDA (May

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products, the agency generally concluded that they were “appropriate for the protection of public

health” because they can benefit adult smokers by helping them switch to less harmful tobacco

products.394 Until May 2026, FDA had not authorized any dessert-, candy-, or fruit-flavored

(sweet-flavored) e-cigarettes for lawful marketing. According to FDA, the applications for such

products up until then “lacked sufficient evidence that the benefit to adult smokers who used the

flavor products would overcome the public health concern posed by the well-documented and

considerable appeal of the products to youth.”395 On May 5, 2026, FDA authorized two fruitflavored e-cigarette products for the first time.396 The agency concluded that the products’ “device

access restriction technology, combined with FDA-required marketing restrictions, is expected to

effectively mitigate the ability of youth to use the product.”397 The relevant access restriction

technology requires users to (1) verify their age and identity with a government-issued ID and

pair the device with a smartphone via Bluetooth; (2) be in proximity with the smartphone in order

for the device to operate; and (3) periodically confirm that the registered user is the one using the

device through random biometric check-ins.398

FD&C Act Section 916: Provision Including Express Preemption Clause Related

to Tobacco Products

The TCA also included a provision, at FD&C Act section 916, that addresses the interaction of

federal and state/local laws. Prior to the TCA’s enactment in 2009, federal laws regulating

tobacco products were primarily focused on certain labeling requirements and advertising

restrictions for certain tobacco products.399 Accordingly, before 2009, states and localities played

a key role in regulating the sale and use of tobacco products within their respective jurisdictions.

For instance, states and localities, to varying degrees, mandated smoke-free indoor and outdoor

5, 2026), https://www.fda.gov/tobacco-products/market-and-distribute-tobacco-product/e-cigarettes-vapes-and-otherelectronic-nicotine-delivery-systems-ends-authorized-fda [https://perma.cc/667S-9TTZ].

394 See, e.g., Press Release, FDA, FDA Authorizes Marketing of Four Menthol-Flavored E-Cigarette Products After

Extensive Scientific Review (June 21, 2024), https://www.fda.gov/news-events/press-announcements/fda-authorizesmarketing-four-menthol-flavored-e-cigarette-products-after-extensive-scientific [https://perma.cc/D6DQ-VMKG];

FDA Issues Marketing Decisions on NJOY Ace E-Cigarette Products, FDA (Apr. 26, 2022),

https://www.fda.gov/tobacco-products/ctp-newsroom/fda-issues-marketing-decisions-njoy-ace-e-cigarette-products

[https://perma.cc/JT7M-L6UJ].

395 Press Release, FDA, FDA Permits Marketing of E-Cigarette Products, Marking First Authorization of Its Kind by

the Agency (Oct. 12, 2021), https://web.archive.org/web/20211221170154/https://www.fda.gov/news-events/pressannouncements/fda-permits-marketing-e-cigarette-products-marking-first-authorization-its-kind-agency.

396 Press Release, FDA, FDA Expands Market Access, Authorizes New ENDS Products (May 5, 2026),

https://www.fda.gov/news-events/press-announcements/fda-expands-market-access-authorizes-new-ends-products

[https://perma.cc/4726-CACT] [FDA May 2026 Press Release] (stating that FDA had authorized “four Glas [e-cigarette

products] . . . . including Classic Menthol, Fresh Menthol, Gold, and Sapphire); Press Release, Am. College of

Cardiology, FDA Update: Agency Authorizes Sale of Fruit Flavored Glas E-Cigarettes (May 6, 2026),

https://www.acc.org/latest-in-cardiology/articles/2026/05/06/16/56/fda-update-agency-authorizes-sale-of-fruitflavored-glas-e-cigarettes [https://perma.cc/S4PN-92TF] (stating that FDA had authorized the marketing of “four Glas

e-cigarettes, including the following pod flavors: Classic Menthol, Fresh Menthol, Gold (mango flavored) and Sapphire

(blueberry flavor)”).

397

FDA May 2026 Press Release, supra note 396.

398 Id.

399 See supra note 389 and accompanying text.

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spaces,400 prohibited the sales of cigarettes in vending machines and near schools,401 and imposed

excise taxes on tobacco products.402 Section 916, entitled “Preservation of State and local

authority,” addresses the interaction of the TCA and relevant state and local laws in three parts.403

The first part of section 916, at subsection (a)(1), is often referred to as the preservation clause.404

It generally states that, subject to the preemption clause at subsection (a)(2)(A), nothing in the

TCA and its implementing rules shall be construed to limit the authority of a federal agency, state,

locality, or tribe to enact or promulgate “any law, rule, regulation, or other measure with respect

to tobacco products that is in addition to, or more stringent than, requirements established under

[the TCA].”405 Subsection (a) specifies that such additional requirements include those “relating

to or prohibiting the sale, distribution, possession, exposure to, access to, advertising and

promotion of, or use of tobacco products by individuals of any age, information reporting to the

State, or measures relating to fire safety standards for tobacco products.”406

The second part of section 916, at subsection (a)(1)(A), is a preemption clause.407 It states that

No State or political subdivision of a State may establish or continue in effect with respect

to a tobacco product any requirement which is different from, or in addition to, any

requirement under the provisions of [the TCA] relating to tobacco product standards,

premarket review, adulteration, misbranding, labeling, registration, good manufacturing

standards, or modified risk tobacco products.408

The third part of section 916, at subsection (a)(1)(B), is a savings clause that qualifies the

preemption clause.409 It states that the preemption clause “does not apply to requirements relating

to the sale, distribution, possession, information reporting to the State, exposure to, access to, the

advertising and promotion of, or use of, tobacco products by individuals of any age, or relating to

fire safety standards for tobacco products.”410

Section 916(b) clarifies that “no provision of [the TCA] relating to a tobacco product shall be

construed to modify or otherwise affect any action or the liability of any person under the product

liability law of any State.”411

400 See AM. NONSMOKERS’ RTS. FOUND., CHRONOLOGICAL TABLE OF U.S. POPULATION PROTECTED BY 100% SMOKEFREE

STATE OR LOCAL LAWS (2026), https://no-smoke.org/wp-content/uploads/pdf/EffectivePopulationList.pdf

[https://perma.cc/XLF6-7BK9].

401 See R.J. Reynolds Tobacco Co. v. Cnty. of Los Angeles, 29 F.4th 542, 549 (9th Cir. 2022); see also State Laws on

Tobacco Control—United States, 1998, CTRS. FOR DISEASE CONTROL & PREVENTION, MMWR (June 25, 1999),

https://www.cdc.gov/mmwr/preview/mmwrhtml/ss4803a2.htm [https://perma.cc/CRT7-WDC2] (providing an

overview of state laws on tobacco control as of 1998).

402 State Laws on Tobacco Control—United States, 1998, supra note 401.

403 21 U.S.C. § 387p.

404 See, e.g., R.J. Reynolds Tobacco Co. v. City of Edina, 60 F.4th 1170 (8th Cir. 2023) (“To achieve national

uniformity while still respecting States’ police power, the [TCA] has three sections relating to preemption: the

Preservation Clause, the Preemption Clause, and the Savings Clause.”).

405 21 U.S.C. § 387p(a)(1).

406 Id. § 387p(a)(1).

407 Id. § 387p(a)(2)(A).

408 Id.

409

Id. § 387p(a)(2)(B).

410 Id.

411 Id. § 387p(b).

Congressional Research Service

39

Preemption and the Federal Food, Drug, and Cosmetic Act (FD&C Act)

Case Law on the Preemptive Scope of FD&C Act Section 916

As states and localities continue to play a role in the regulation of tobacco products, lower courts

have considered the preemptive scope of FD&C Act section 916 on several occasions, primarily

in the context of e-cigarette regulation. Sweet-flavored e-cigarettes have been widely available,412

even though FDA, until May 2026, had not authorized the lawful marketing of any such

products.413 To address the availability of unauthorized flavored e-cigarettes, some states and

localities have, for instance, restricted or banned the sale

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