Petition for Writ of Certiorari — Moose Jooce, et al., Petitioners v. Food and Drug Administration, et al.

Appendix A-1

UNITED STATES COURT OF APPEALS

FOR THE DISTRICT OF COLUMBIA CIRCUIT

________

Argued Sept. 23, 2020

Decided Dec. 1, 2020

No. 20-5048

MOOSE JOOCE, ET AL.,

APPELLANTS

v.

FOOD & DRUG ADMINISTRATION, ET AL.,

APPELLEES

________

Consolidated with 20-5049, 20-5050

________

Appeals from the United States District Court

for the District of Columbia

(No. 1:18-cv-00203)

(No. 1:18-cv-01615)

(No. 1:19-cv-00372)

________

Jonathan Wood argued the cause for appellants.

With him on the briefs were Damien M. Schiff and

Oliver Dunford.

Lindsey Powell, Attorney, U.S. Department of

Justice, argued the cause for appellees. With her on

the brief were Mark B. Stern and Joshua Revesz,

Attorneys, Robert P. Charrow, General Counsel, U.S.

Department of Health and Human Services, and

Peter G. Dickos, Associate Chief Counsel, Food and

Drug Administration.

Appendix A-2

Before: ROGERS and PILLARD, Circuit Judges, and

SENTELLE, Senior Circuit Judge.

Opinion of the Court by Circuit Judge ROGERS.

ROGERS, Circuit Judge: Less than a year ago, the

court rejected three challenges by an e-cigarette

manufacturer and distributor, and an e-cigarette

industry group to a rule deeming e-cigarettes to be

“tobacco products” subject to regulation under the

Family Smoking Prevention and Tobacco Control Act,

Pub. L. No. 111-31, 123 Stat. 1776 (2009) (“the Act”).

In Nicopure Labs, LLC v. FDA, 944 F.3d 267, 271

(D.C. Cir. 2019), the court held that it was “entirely

rational and nonarbitrary [for the Food and Drug

Administration (“FDA”)] to apply to e-cigarettes the

Act’s baseline requirement that, before any new

tobacco product may be marketed, its manufacturer

show the FDA that selling it is consistent with the

public health.” The court also rejected First

Amendment objections to the Act’s barring of claims

that e-cigarettes are safer than existing products

absent such a demonstration and ban on the

distribution of free e-cigarette samples. Id. at 272.

Now other e-cigarette manufacturers and retailers,

and a nonprofit organization focused on tobacco harm

reduction raise two constitutional challenges to the

rule. Under this court’s precedents, their

Appointments Clause challenge lacks merit and their

First Amendment challenge is foreclosed. Accordingly,

we affirm the grant of summary judgment to the FDA.

I.

The Act authorizes the Secretary of the

Department of Health and Human Services to

regulate the manufacture, sale, and distribution of

Appendix A-3

tobacco products. It permits the Secretary to deem

products to be “tobacco products” subject to the Act’s

requirements. 21 U.S.C. § 387a(b) (2018). One such

requirement is the preclearance pathway for

manufacturers seeking to market a “modified risk

tobacco product,” defined as “any tobacco product that

is sold or distributed for use to reduce harm or the risk

of

tobacco-related

disease

associated

with

commercially marketed tobacco products.” Id.

§ 387k(b)(1). Under the Act, a modified risk tobacco

product may be commercially marketed only if the

Secretary determines that the manufacturer has

demonstrated that the product, as actually used by

consumers, meets two requirements. Id. § 387k(g)(1).

First, the product will “significantly reduce harm and

the risk of tobacco-related disease to individual

tobacco users.” Id. § 387k(g)(1)(A). Second, it will

“benefit the health of the population as a whole taking

into account both users of tobacco products and

persons who do not currently use tobacco products.”

Id. § 387k(g)(1)(B).

The Secretary of the Department delegated

rulemaking authority to the FDA Commissioner. See,

e.g., FDA Staff Manual Guide § 1410.10 (Aug. 26,

2016); id. § 1410.10 (Nov. 17, 2015). The FDA

Commissioner, in turn, redelegated rulemaking

authority to the FDA Associate Commissioner for

Policy. See id. § 1410.21(1)(G) (July 5, 2012).

According to the 2012 FDA Staff Manual Guide, the

Associate Commissioner for Policy had the authority

to “perform any of the functions of the Commissioner

with respect to the issuance of [Federal Register]

notices and proposed and final regulations of the Food

and Drug Administration.” Id.

Appendix A-4

In April 2014, the FDA published a proposed rule

to deem e-cigarettes, among other items, “tobacco

products” under the Act. See 79 Fed. Reg. 23,142,

23,143 (Apr. 25, 2014). The comment period was

extended until August 8, 2014. See id. at 35,711

(June 24, 2014). After considering comments, FDA

Associate Commissioner for Policy Leslie Kux

promulgated a rule in May 2016 that deemed ecigarettes to be “tobacco products” subject to the Act’s

requirements. See Deeming Products To Be Subject to

the Federal Food, Drug, and Cosmetic Act, as

Amended by the Family Smoking Prevention and

Tobacco Control Act, 81 Fed. Reg. 28,974, 28,976

(May 10, 2016) (codified at 21 C.F.R. §§ 1100, 1140,

1143) (“Deeming Rule”).

On January 30, 2018, appellants sued the FDA

challenging the Deeming Rule under the

Appointments Clause and the First Amendment of the

Constitution. The district court, exercising its

discretion to consider the Appointments Clause

challenge even though it was not raised during the

rulemaking, granted summary judgment to the FDA.

Appellants appeal, and our review is de novo, see Mayo

v. Reynolds, 875 F.3d 11, 19 (D.C. Cir. 2017).

II.

The Appointments Clause requires that “all . . .

Officers of the United States” be appointed by the

President “by and with the Advice and Consent of the

Senate.” U.S. CONST. art. II, § 2, cl. 2. “This

requirement is the ‘default manner of appointment,’

Edmond v. United States, 520 U.S. 651, 660, 117 S. Ct.

1573, 137 L.Ed.2d 917 (1997), with the only exception

being that Congress may vest the appointment of

‘inferior Officers’ in ‘the President alone,’ ‘Courts of

Appendix A-5

Law,’ and ‘the Heads of Departments,’ U.S. CONST.

art. II, § 2, cl. 2.” Guedes v. Bureau of Alcohol, Tobacco,

Firearms & Explosives, 920 F.3d 1, 11 (D.C. Cir. 2019).

Appellants contend that the position of Associate

Commissioner for Policy may be filled by only a

properly appointed officer of the United States, and

that Kux was not appointed as either an inferior or

principal officer. They maintain that Kux’s issuance of

the Deeming Rule was consequently in violation of the

Appointments Clause and void ab initio. See

Appellants’ Br. 49–60. The FDA rejects the challenge

to Kux’s authority and points further to ratifications

of the Deeming Rule by FDA Commissioners Robert

Califf and Scott Gottlieb. Either ratification, it

maintains, suffices to render the Rule constitutional.

See Appellees’ Br. 16–27, 31–38.

“Ratification occurs when a principal sanctions

the prior actions of its purported agent.” Doolin Sec.

Sav. Bank, F.S.B. v. Office of Thrift Supervision, 139

F.3d 203, 212 (D.C. Cir. 1998) (citing RESTATEMENT

(SECOND) OF AGENCY § 82 (1958)), superseded by

statute on other grounds, Federal Vacancies Reform

Act of 1998, Pub. L. No. 105-277, 112 Stat. 2681 (1998)

(codified at 5 U.S.C. §§ 3345 to 3349d), as this court

recognized in Guedes, 920 F.3d at 13. This court has

repeatedly recognized that ratification can remedy a

defect arising from the decision of an improperly

appointed official, such as the alleged defect arising

from the issuance of the Deeming Rule by Associate

Commissioner for Policy Kux. Wilkes-Barre Hosp. Co.,

LLC v. NLRB, 857 F.3d 364, 371 (D.C. Cir. 2017)

(citing Intercollegiate Broad. Sys., Inc. v. Copyright

Royalty Bd., 796 F.3d 111, 117–21, 124 (D.C. Cir.

2015)). Even assuming for purposes of argument, as

Appendix A-6

appellants object, that Kux’s issuance of the Deeming

Rule violated the Appointments Clause and that

Commissioner Califf’s general ratification of prior

actions by the FDA as part of an agency

reorganization was invalid, Commissioner Gottlieb’s

ratification cured any Appointments Clause defect.

A.

On April 3, 2019, noting that the “authority under

which the Deeming Rule was issued has been

questioned in litigation,” then-FDA Commissioner

Scott Gottlieb stated: “To resolve these questions, I

hereby affirm and ratify the Deeming Rule as of the

date it was published in the Federal Register on

May 10, 2016, including all regulatory analysis

certifications contained therein.” Ratification of the

Deeming Rule, 81 Fed. Reg. 28,974 (May 10, 2016)

(signed by Scott Gottlieb, M.D., on Apr. 3, 2019). He

specified: “I undertake this action based on my careful

review of the rule, my knowledge of its provisions, and

my close involvement in policy matters relating to this

rule and its implementation, as well as its public

health importance.” Id.

Appellants’ challenges to the effectiveness of

Commissioner Gottlieb’s ratification fail. They

maintain that Commissioner Gottlieb lacked the

authority to ratify the Deeming Rule after they filed

suit in federal district court. Even assuming this

challenge is not forfeited by their failure to raise it in

the district court, see Salazar ex rel. Salazar v. District

of Columbia, 602 F.3d 431, 437 (D.C. Cir. 2010),

appellants fail to distinguish FEC v. Legi-Tech, Inc.,

75 F.3d 704, 707–09 (D.C. Cir. 1996), where the court

held that the Federal Election Commission effectively

ratified its prior actions even though its ratification

Appendix A-7

occurred after Legi-Tech alleged an Appointments

Clause violation.

Appellants further maintain that “Commissioner

Gottlieb lacked the power to issue the Deeming Rule

in April 2019 because to do so would have been

arbitrary and capricious.” Appellants’ Br. 28. In

appellants’ view, for ratification to be effective, a

ratifying party “should be able not merely to do the act

ratified at the time the act was done, but also at the

time the ratification was made.” Id. (quoting FEC v.

NRA Political Victory Fund, 513 U.S. 88, 98 (1994)).

Relying on Butte County v. Hogen, 613 F.3d 190 (D.C.

Cir. 2010), for the proposition that administrative

officials must consider new evidence in order to make

non-arbitrary, reasoned decisions, appellants note

that during the nearly three years between the

Deeming Rule’s issuance and Commissioner Gottlieb’s

ratification, “dozens of public comments submitted to

FDA had pointed the Commissioner to a wealth of new

evidence regarding the benefits of vaping to public

health.” Appellants’ Br. 30. Butte County does not

advance appellants’ position. In that case, the agency

failed to consider a report that was submitted while

the “issue was still pending before the Secretary.”

Butte County, 613 F.3d at 195. Here, the rulemaking

record closed in 2016 and consequently Commissioner

Gottlieb had no such obligation to consider new

evidence in 2019. Therefore, it was not arbitrary and

capricious for him to ratify the Deeming Rule without

considering the new evidence that appellants

reference.

Furthermore, nothing in the record indicates that

Commissioner Gottlieb, when he ratified the Deeming

Rule, failed “to conduct an independent evaluation of

Appendix A-8

the merits,” Intercollegiate Broadcasting, 796 F.3d at

117, or to make “a detached and considered

judgment,” Doolin Sec., 139 F.3d at 213. Nor do

appellants suggest that Commissioner Gottlieb was

“actually biased.” Legi-Tech, 75 F.3d at 709.

Because Commissioner Gottlieb effectively

ratified the Deeming Rule, the court need not consider

appellants’ Appointments Clause objections to

Commissioner Califf’s ratification or to Associate

Commissioner for Policy Kux’s issuance of the Rule.

Given that the Act does not mandate administrative

exhaustion as a prerequisite to judicial review, the

court also need not address the FDA’s alternative

contention

that

appellants

forfeited

their

Appointments Clause claim by failing to raise it before

the agency. See Darby v. Cisneros, 509 U.S. 137, 147

(1993); 21 U.S.C. § 387l (2018).

B.

Notwithstanding

Commissioner

Gottlieb’s

effective ratification, appellants contend that

Appointments Clause violations are per se harmful,

not curable by ratification, and so the court should

consider the merits of their challenge to the Deeming

Rule and the asserted “continuing prejudice” they

suffer. Appellants’ Br. 41–46. They suggest that a

different notice-and-comment process might “affect

the contents or even the existence of a new Deeming

Rule” in view of the “new evidence accumulated since

the Deeming Rule’s issuance” and the “FDA’s postpromulgation guidances . . . [that] have effectively,

though only informally, eased some of the original

Deeming Rule’s effects.” Id. at 42–45. In Legi-Tech, 75

F.3d at 708–09, this court rejected the view that

prejudice must be presumed for Appointments Clause

Appendix A-9

violations.

Subsequently,

in

Intercollegiate

Broadcasting, 796 F.3d at 124, the court emphasized

that “not every possible kind of taint is fatal” and that

“speculative taint” such as the possibility that an

invalid action was subsequently affirmed “simply out

of agency solidarity” is insufficient.

Appellants

demonstrate

no

“continuing

prejudice.” In the preamble to the Rule, the FDA

acknowledged that there was uncertainty about the

health effects of e-cigarettes, but concluded that the

regulation of e-cigarettes “will still benefit public

health” even if e-cigarettes “may eventually be shown

to have a net benefit on or harm to public health at the

population level.” Deeming Rule, 81 Fed. Reg. 28,974,

28,984 (May 10, 2016). Absent record evidence of

continuing

prejudice,

the

court

will

take

Commissioner Gottlieb’s ratification “at face value

and treat it as an adequate remedy.” Wilkes-Barre

Hosp., 857 F.3d at 372 (quoting Legi-Tech, 75 F.3d at

709).

Contrary to appellants’ suggestion that

ratification of an action “merely moots an

Appointments Clause claim, and the voluntary

cessation exception to mootness applies,” Appellants’

Br. 46, this court has “repeatedly held that a properly

appointed official’s ratification of an allegedly

improper official’s prior action, rather than mooting

the claim, resolves the claim on the merits by

‘remedy[ing] [the] defect’ (if any) from the initial

appointment.” Guedes, 920 F.3d at 13 (quoting WilkesBarre Hosp., 857 F.3d at 371). Commissioner

Gottlieb’s ratification, for the reasons discussed, cured

any potential Appointments Clause defect arising

Appendix A-10

from Associate Commissioner for Policy

issuance of the Deeming Rule.

Kux’s

II.

Appellants

further

challenge

the

Act’s

preclearance pathway for modified risk tobacco

products, which the Deeming Rule makes applicable

to e-cigarettes, as violative of the First Amendment.

This challenge is foreclosed by Nicopure Labs, LLC,

944 F.3d 267. There, the court found unpersuasive the

objection that appellants make now, namely that the

Deeming Rule violates the First Amendment because

it places the burden on manufacturers to show that

certain of their marketing claims are truthful and not

misleading before they make them. See id. at 282–90;

Appellants’ Br. 60–64. The court sustained the

preclearance pathway even when applied to modifiedrisk statements that manufacturers insist are

“accurate” — such as claims that e-cigarettes contain

less of or are free of specified ingredients — because

“modified risk claims that might be technically

accurate if viewed in isolation are in fact often

misunderstood by consumers.” Id. at 287.

Accordingly, we affirm the grant of summary

judgment to the FDA.

Appendix B-1

Filed 02/11/2020

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

MOOSE JOOCE, et al.,

Plaintiffs,

v.

FOOD AND DRUG

ADMINISTRATION,

et al.,

Case No. 18-cv-203

(CRC)

Defendants.

RAVE SALON, INC.

d/b/a JOOSIE VAPES,

Plaintiff,

v.

FOOD AND DRUG

ADMINISTRATION,

et al.,

Case No. 18-cv-1615

(CRC)

Defendants.

JEN HOBAN

d/b/a MASTERPIECE

VAPORS, et al.,

Plaintiffs,

v.

FOOD AND DRUG

ADMINISTRATION,

et al.,

Defendants.

Case No. 19-cv-372

(CRC)

Appendix B-2

MEMORANDUM OPINION

Responding to the public health risks posed by

dramatic increases in vaping, especially among teens,

the Food and Drug Administration in 2016 exercised

its statutory authority to regulate electronic

cigarettes.1 It did so by issuing a final rule that

deemed e-cigarettes to be “tobacco products” subject to

regulation under the Family Smoking Prevention and

Tobacco Control Act, Pub. L. No. 111-31, 123 Stat.

1776 (2009) (“Tobacco Control Act”). As a result of this

“Deeming Rule,” e-cigarettes are now subject to all the

same types of regulations as traditional cigarettes,

including restrictions on advertising, a ban on sales to

minors, and requirements for nicotine warnings on

packaging and advertisements.

In these consolidated cases, a collection of ecigarette manufacturers and retailers challenge the

Deeming Rule under the Appointments Clause and

the First Amendment of the U.S. Constitution. First,

they contend that the rule violates the Appointments

Clause because the FDA official who signed it was

neither a Senate-confirmed “principal officer” nor a

duly appointed and supervised “inferior officer.” The

Court will reject Plaintiffs’ challenge. Since the

Deeming Rule was issued, two Senate-confirmed FDA

Commissioners have ratified it. These ratifications

were effective and cured any potential Appointments

1 This Opinion uses the term “e-cigarettes” to refer to all

electronic nicotine delivery systems (ENDS) deemed to be

tobacco products by the FDA, such as e-cigars, e-hookah, vape

pens, personal vaporizers, and electronic pipes. See 81 Fed. Reg.

28,974, 29,028 (May 10, 2016); APP 306. These products include

both “cigalikes,” which mimic traditional cigarettes, and

electronic devices that resemble everyday objects like flash

drives.

Appendix B-3

Clause defect in the rule’s issuance. Because it

upholds the ratifications, the Court need not decide

the merits of Plaintiffs’ constitutional argument.

Second, Plaintiffs argue that a pre-clearance

requirement in the Tobacco Control Act now

applicable to e-cigarettes violates the First

Amendment because it places the burden on

manufacturers to show that certain of their marketing

claims are truthful and not misleading before they

may make them. Since this case was filed, the D.C.

Circuit issued an opinion in Nicopure Labs, LLC v.

FDA, 944 F.3d 267 (D.C. Cir. 2019), on a substantially

similar claim. The Court finds that Nicopure Labs

directly controls the question raised here and requires

dismissal of Plaintiff’s First Amendment challenge.

I.

Background

The Tobacco Control Act gives the Secretary of

Health and Human Services authority to regulate four

enumerated categories of tobacco products—namely

“all cigarettes, cigarette tobacco, roll-your-own

tobacco, and smokeless tobacco”—as well as “any

other tobacco products that the Secretary by

regulation deems to be subject to this subchapter.” 21

U.S.C. § 387a(b). The HHS Secretary delegated this

ability to “deem” tobacco products subject to the Act to

the FDA Commissioner, who then sub-delegated that

authority to the FDA’s Assistant Commissioner for

Policy (“ACP”).2 See 21 U. S.C. § 393(d)(2)(E)

2 The

position has since been renamed the Associate

Commissioner for Policy as a part of an agency reorganization.

This Opinion will use “ACP” to refer to both the Assistant

Commissioner and the Associate Commissioner as those

positions had the same relevant responsibility, namely to

promulgate rules for the FDA under the Tobacco Control Act.

Appendix B-4

(permitting the HHS Secretary to delegate “such other

functions as the Secretary may prescribe”); 2015 FDA

Staff Manual Guide (“SMG”) § 1410.10(1)(A)(14), J.A.

20 (delegation of authority to Commissioner); 2015

SMG § 1410.l0(l)(A), J.A. 19 (delegation of authority

to ACP). The HHS Secretary expressly “reserve[d] the

authority to approve regulations of the FDA” that

“establish procedural rules applicable to a general

class” or “present highly significant public issues.”

2015 SMG § 1410.10(2)(A), J.A. 20. The FDA

Commissioner, in turn, reserved the power to

“continue to exercise all delegated authority.” 2012

SMG § 1410.21(1)(G)(l), J.A. 43; id. § 1410.21(1)(A),

J.A. 40.

In 2014, the FDA issued a Notice of Proposed

Rulemaking, signed by the ACP, seeking comments on

its plan to deem all tobacco products, including ecigarettes, subject to regulation under the Tobacco

Control Act. 80 Fed. Reg. 23,141 (Apr. 25, 2014), J.A.

141. At least one of the Plaintiffs here submitted a

comment to the FDA, arguing that the proposed rule

did not take into account the positive benefits of ecigarette use (or “vaping”) and did not appropriately

tailor the regulations to the retail vaping industry in

light of those benefits. Dennisa Moore, Joosie Vapes

Inc., Comment Letter on Proposed Rule Deeming

Tobacco Products to be Subject to the FDCA as

amended by the Family Smoking Prevention and

Tobacco Control Act (Aug. 6, 2014), J.A. FDA 12527274. None of the more than 135,000 commenters

challenged the ACP’s authority to sign the proposed

or final rule.

The final Deeming Rule, also signed by the ACP,

was issued two years later. 81 Fed. Reg. at 28,973-

Appendix B-5

29,106, J.A. 252-384. In response to comments

received on the proposed rule, the FDA considered “a

robust body of scientific evidence about the uses and

risks of e-cigarettes,” Nicopure Labs, 944 F.3d at 273.

This evidence included studies showing that ecigarettes have the potential ability to help adults quit

smoking conventional cigarettes, as well as studies

indicating that young people who vape are more likely

to begin smoking cigarettes. 81 Fed. Reg. at 29,03641, J.A. 314-19. Balancing all the evidence, the FDA

decided that risks of nicotine addiction for nonsmoking youth outweighed the purported (and

disputed) benefits of smoking cessation for adults. Id.

The Deeming Rule subjects e-cigarettes to the

Tobacco Control Act and regulates their distribution,

marketing, and labeling in two general ways: first, to

reduce youth access, it bans sales to people under 18,

requires ID checks for people under 26, and bans

vending machine sales except in adult-only facilities,

81 Fed. Reg. at 29,057, J.A. 335; second, to inform

consumers of the consequences of using the product, it

requires packages and advertisements to contain a

warning about the addictive nature of nicotine, 81

Fed. Reg. at 29,060, J.A. 338. In addition, several

provisions in the Tobacco Control Act and its

implementing regulations automatically applied to ecigarettes upon issuance of the final rule, such as

regulations on misbranding, ingredient lists, and free

samples. 81 Fed. Reg. at 29,051, J.A. 329. One

provision now applicable to e-cigarettes specifically

challenged here is the Tobacco Control Act’s preclearance requirement for “modified risk products.”

The Act places the burden on a manufacture to show

that a tobacco product “is safer than other tobacco

products” before it may market it as such. The Act

Appendix B-6

requires manufacturers “to substantiate such claims

with evidence of their overall public health effects in

advance of marketing, and to show that the proposed

product as marketed will not mislead consumers as to

its safety.” Nicopure Labs, 944 F.3d at 284.

Since its issuance, the Deeming Rule has been

ratified

by

two

Senate-confirmed

FDA

Commissioners.

In

September

2016,

FDA

Commissioner Robert Califf ratified all of the agency’s

prior actions—including the Deeming Rule—as a part

of a broad agency reorganization. J.A. 144. And after

this litigation began, Commissioner Scott Gottlieb

specifically ratified the Deeming Rule in April 2019.

J.A. 231. He wrote:

I hereby affirm and ratify the Deeming Rule

as of the date it was published in the Federal

Register on May 10, 2016, including all

regulatory analysis certifications contained

therein. I undertake this action based on my

careful review of the rule, my knowledge of its

provisions, and my close involvement in policy

matters relating to this rule and its

implementation, as well as its public health

importance.

Id.

According to Plaintiffs, between the time of the

Rule’s promulgation and the Commissioners’

ratifications, several additional studies showed that ecigarettes may help adults quit smoking cigarettes

and reduce the adverse health effects of cigarettes. See

Pls.’ Opening Br. at 31-33 (citing studies). Other

studies, Plaintiffs say, showed that certain

regulations, which result in higher e-cigarette prices,

Appendix B-7

have the effect of increasing the number of young

people who smoke conventional cigarettes. Id. at 34.

Also during this interim period, the FDA issued

guidance documents that have adjusted some of the

compliance deadlines in the final rule. Id.

Three sets of plaintiffs filed suit against the FDA

alleging that the ACP was not appointed consistent

with the Appointments Clause and, therefore, that

her execution of the notice of proposed rulemaking

and the final rule requires the court to “set aside” the

Deeming Rule. See, e.g., Moose Jooce Compl. ¶¶ 50-52

(quoting APA § 706(2)(A)). The parties have filed

cross-motions for summary judgment on that issue.

The Court held a hearing on October 22, 2019.

Plaintiffs also challenge the premarket review

requirement for “modified risk tobacco products”

under the First Amendment. See, e.g., Moose Jooce

Compl. ¶¶ 54-57. The Court stayed briefing on that

issue to await the D.C. Circuit’s ruling on a

substantially similar issue in Nicopure Labs. See

Minute Order, June 8, 2018. After the D.C. Circuit

decided that case in early December 2019, the Court

asked the parties whether additional briefing was

required. Plaintiffs responded that further briefing is

necessary because the issue decided by the Circuit is

distinguishable from the issues raised here, while the

FDA maintained that the Circuit’s opinion clearly

forecloses Plaintiffs’ First Amendment claim. See

Joint Status Report (“JSR”) (Dec. 17, 2019), ECF 42.

II. Legal Standards

Summary judgment may be granted when “there

is no genuine issue as to any material fact and the

movant is entitled to judgment as a matter of law.”

Appendix B-8

Fed. R. Civ. P. 56(a). Whether an agency action

violates the Appointments Clause is a pure question

of law that is properly decided by summary judgment.

See, e.g., Estes v. U.S. Dep’t of the Treasury, 219 F.

Supp. 3d 17, 38-39 (D.D.C. 2016); see also 5 U.S.C.

§ 706(2)(A) (requiring courts to “hold unlawful and set

aside agency action, findings, and conclusions found

to be . . . arbitrary, capricious, an abuse of discretion,

or otherwise not in accordance with law”).

III. Analysis

A. The Appointments Clause

1. Forfeiture

As a threshold matter, the FDA contends that

Plaintiffs forfeited their Appointments Clause

challenge by not raising it during the rule’s noticeand-comment period. Gov’t’s Cross-Mot. for Partial

Summ. J. 18-20. They agency is correct that generally

“a party must initially present its comments to the

[relevant] agency during the rulemaking in order for

the court to consider the issue,” Tex Tin Corp. v. EPA,

935 F.2d 1321, 1323 (D.C. Cir. 1991), and that

“[s]imple fairness . . . requires as a general rule that

courts should not topple over administrative decisions

unless the administrative body . . . has erred against

objection made at the time” of its decision, Advocates

for Highway & Auto Safety v. Fed. Motor Carrier

Safety Admin., 429 F.3d 1136, 1150 (D.C. Cir. 2005)

(quoting United States v. L.A. Tucker Truck Lines,

Inc., 344 U.S. 33, 37 (1952)). Appointments Clause

claims are not immune from forfeiture. See, e.g.,

Intercollegiate Broad. Sys., Inc. v. Copyright Royalty

Bd., 574 F.3d 748, 755-56 (D.C. Cir. 2009)

(“Intercollegiate I”) (declining to consider an

Appendix B-9

Appointments Clause challenge not raised in opening

appellate brief).

But courts have discretion to consider an untimely

objection in “rare cases.” Freytag, 501 U.S. at 879

(explaining, in the context of an agency adjudication,

that avoiding “the disruption to sound appellate

process entailed by entertaining objections not raised

below does not always overcome what Justice Harlan

called ‘the strong interest of the federal judiciary in

maintaining the constitutional plan of separation of

powers.’” (quoting Glidden Co. v. Zdanok, 370 U.S.

530, 535-536 (1962) (Harlan, J., plurality opinion))).

The Court chooses it exercise its discretion here.

Unlike the appellant in Intercollegiate I, Plaintiffs

have offered a reason to “depart from [the] normal

forfeiture rule” and have offered a strong “justification

for its delay.” 574 F.3d at 756. Rulemaking is different

from adjudication. See Citizens Coal Council v. EPA,

447 F.3d 879, 904 n.25 (6th Cir. 2006) (noting that

forfeiture rules “should not be applied freely in both”

rulemaking and adjudication contexts, “given the

fundamental differences between the two endeavors”).

Even though the forfeiture rules may apply in both

contexts, Styrene Info. & Research Ctr. v. Sebelius, 994

F. Supp. 2d 71, 79 (D.D.C. 2013), and parties surely

can forfeit arguments not made before the agency

during a comment period, see, e.g., Advocates for

Highway & Auto Safety, 429 F.3d at 1150, the

differences between rulemaking and adjudication

counsel for a more lenient rule for unrepresented

commenters who later wish to raise a separation-ofpowers argument. Interested parties who are not

attorneys or represented by counsel will naturally

submit comments focusing on the rule’s potential

impact on them. It would be unfair to require them to

Appendix B-10

raise esoteric legal arguments with the agency or else

be prevented later from arguing them to a court,

especially when those arguments relate to important

separation-of-powers issues. Compare Intercollegiate

I, 574 F.3d at 755-56 (applying forfeiture rules to a

represented party who failed to raise its Appointments

Clause challenge in an agency adjudication or its

opening brief in federal court). Any prejudice to the

agency pales in comparison to the unfairness to

Plaintiffs, particularly considering the FDA can

rectify any Appointments Clause problem through an

effective ratification after litigation is commenced, see

Part III.B., supra.

In the absence of any indication that Plaintiffs

were represented during the comment period, see Mot.

Hr’g Tr. 27:11-15 (Oct. 22, 2019) (rough), the Court

will exercise its discretion to consider their

Appointments Clause claim.

2. Ratification

a. Merits

Plaintiffs contend that the Deeming Rule is

invalid because it was promulgated by an FDA

employee who had not been properly appointed as an

officer of the United States and therefore lacked

authority under the Appointments Clause to issue

binding agency rules. But the Deeming Rule was

ratified by two different FDA Commissioners after its

publication in May 2016, and the D.C. Circuit has

repeatedly held that an agency’s ratification of a prior

decision or action cures any potential Appointments

Clause violation if “a properly appointed official has

the power to conduct an independent evaluation of the

merits and does so.” Intercollegiate Broad. Sys. v.

Appendix B-11

Copyright Royalty Bd., 796 F.3d 111, 117 (D.C. Cir.

2015) (“Intercollegiate III”) (citing FEC v. Legi-Tech,

Inc., 75 F.3d 704 (D.C. Cir. 1996) and Doolin Security

Savings Bank v. Office of Thrift Supervision, 139 F.3d

203 (D.C. Cir. 1998)); see also Wilkes-Barre Hospital

Co. v. NLRB, 857 F.3d 364, 371 (D.C. Cir. 2017). It is

the Plaintiffs’ burden to present evidence—beyond the

mere fact of ratification—“to suggest that the [agency]

failed to conduct an independent evaluation of the

merits or make a detached and considered judgment.”

Wilkes Barre, 857 F.3d at 371 (internal quotation

marks omitted). An “independent judgment” does not

require the ratifier to “return to square one” of the

administrative process. Rather, “the better course” for

courts is to take the ratification “at face value and

treat it as an adequate remedy” for an Appointments

Clause violation. Legi-Tech, 75 F.3d at 708-09

(refusing to “forc[e] the [agency] to start at the

beginning of the administrative process”). The test is

akin to “harmless error” under the APA. Doolin, 139

F.3d at 212-13 (explaining that the test for whether

ratification is an adequate remedy “echoes the

harmless error analysis” that “stems from the last

sentence of § 706 of the Administrative Procedure Act:

on judicial review of agency action, ‘due account shall

be taken of the rule of prejudicial error’”). Under this

test, Plaintiffs bear the burden of providing evidence

that the results of redoing the notice-and-comment

process would yield a different result. Id.

In making that determination, the D.C. Circuit

has instructed district courts not to look behind the

ratification “notwithstanding the possibility” that it is

merely a “rubberstamp” of the prior decision.

Intercollegiate III, 796 F.3d at 118 n.1; see also Doolin,

at 213 (holding that courts should find a ratification

Appendix B-12

effective even if it has “misgivings” about whether

there was a “real fresh deliberation”). To succeed,

Plaintiffs must provide evidence of “continuing

prejudice” of the alleged error after the ratification,

“and whether that degree of prejudice—if it exists—

requires dismissal.” Legi-Tech, 75 F.3d at 708; see

Intercollegiate III, 796 F.3d at 124 (“[T]he subsequent

proceeding is constitutionally suspect only if there is

sufficient continuing taint arising from the first.”).

The Circuit has also cautioned against examining

internal agency deliberations regarding the

ratification “absent a contention” that the ratifier was

“actually biased.” Legi-Tech, 75 F.3d at 709.

Plaintiffs argue that the highly deferential

standard of review that the Circuit established for

agency ratifications in the cases cited above, all of

which involved enforcement actions or adjudications,

does not apply in the context of rulemakings like the

one at issue here. Pls.’ Reply/Opp’n 19-22.

Rulemakings should be treated differently, Plaintiffs

say, because the APA’s procedural rulemaking

requirements, including notice and opportunity for

comment, continue until the moment of ratification.

Id. The Court is not persuaded. Plaintiffs offer no

reason—other than the existence of APA procedures—

for differentiating between ratifications of rules and

ratifications of enforcement decisions or agency

adjudications. Adjudications are also covered by a

host of APA procedures, yet the Circuit has applied its

ratification doctrine to agency adjudications as well.

See Intercollegiate III, 796 F.3d at 119. Up to that

point, the Circuit had only approved ratifications in

the enforcement context, but it rejected the notion

that the type of agency proceeding mattered. Id. And

it has since implied—though did not outright decide—

Appendix B-13

that rulemaking ratifications should be treated the

same way. See Guedes v. Bureau of Alcohol, Tobacco,

Firearms and Explosives, 920 F.3d 1, 12 (D.C. Cir.

2019) (accepting the parties’ agreement that the

ratification was effective to cure an Appointments

Clause problem with a rulemaking).

Further, all the district courts in this District that

have confronted the issue have applied the Circuit’s

ratification doctrine to rulemakings and have not

required agencies to undergo the entire APA noticeand-comment processes anew before upholding

otherwise effective ratifications. These courts have

consistently held that a rulemaking “that would

otherwise be unlawful due to procedural or technical

defects . . . can be cured through a subsequent lawful

ratification of that action.” Alfa Int’l Seafood v. Ross,

No. 17-cv-31, 2017 WL 3738397, at *1 (D.D.C.

June 22, 2017) (Mehta, J.) (explaining that the court

would accept a general post-litigation “statement

[from the agency] acknowledging that [it] would repromulgate the Rule in the same manner, even if it

were required to re-start the notice and comment

process”); see also State Nat’l Bank of Big Spring v.

Lew, 197 F. Supp. 3d 177, 179-80 (D.D.C. 2016)

(Huvelle, J.) (rejecting the notion that a ratification of

a rulemaking requires the agency to redo the full

APA’s notice-and-comment procedures because,

“regardless of the type of administrative action, [D.C.

Circuit] decisions have consistently declined to impose

formalistic procedural requirements before a

ratification is deemed to be effective”); Huntco Pawn

Holdings, LCC v. U.S. Dep’t of Defense, 240 F. Supp.

3d 206, 232 (D.D.C. 2016) (Kollar-Kotelly, J.) (holding

that that a ratification submitted to the court by a

properly appointed official settles “any serious dispute

Appendix B-14

that the Final Rule, as published, reflects the

decisions of the agency with authority to promulgate

it”).

Here, the ratifications by both Commissioner

Califf and Commissioner Gottlieb cured any potential

Appointments Clause issue with the promulgation of

the Deeming Rule.

First, both ratifying Commissioners made “a

detached and considered judgment” of the Deeming

Rule. See Wilkes-Barre, 857 F.3d at 371.

Commissioner Gottlieb ratified the Deeming Rule

explicitly “based on [his] careful review of the rule,

[his] knowledge of its provisions, and [his] close

involvement in policy matters relating to this rule and

its implementation.” J.A. 231. He stated that he made

a detached and considered judgment, and Plaintiffs

have not provided any evidence to the contrary. The

Court must therefore take Commissioner Gottlieb’s

ratification “at face value.” Legi-Tech, 75 F.3d at 709.

And while perhaps a closer question, Commissioner

Califf s blanket ratification also meets the standards

set by the D.C. Circuit. In Wilkes-Barre, the Circuit

approved of a ratification of all “the actions taken

during the period in which the Board lacked a valid

quorum,” 857 F.3d at 271, which is substantially

similar to Commissioner Califf’s ratification of “any

actions taken . . . which in effect involved the

authorities delegated herein prior to the effective date

of this delegation,” J.A. 144. Plaintiffs’ counsel

correctly noted at the hearing that the inference of

“independent judgment” was stronger in Wilkes-Barre

because the ratifier was the same person—though

now validly appointed—who took the original actions.

See Mot. Hr’g Tr. 5:17-6:3 (Oct. 22, 2019) (rough). But

Appendix B-15

again, the Circuit instructs that the independent

judgment of the ratifiers should be taken “at face

value,” unless a plaintiff provides contrary evidence.

Legi-Tech, 75 F.3d at 709. That evidence must be

something more than the mere fact that the decision

is being ratified. As Plaintiffs have not met that

burden, the Court will not look behind

Commissioner’s Califf’s blanket ratification either.

Second, Plaintiffs have not met their burden to

show that any Appointments Clause violation was

prejudicial in the sense that redoing the

administrative process would yield a different result.3

Plaintiffs’ primary contention of error is that neither

of the ratifying Commissioners discussed certain

studies that were published between the issuance of

the Deeming Rule and the later ratifications. Pls.’

MSJ 30-37. By failing to acknowledge these

intervening

studies,

Plaintiffs

argue,

the

Commissioners violated the basic APA rule requiring

3 Citing Legi-Tech, Plaintiffs assert that a court must find that it

is “virtually inconceivable” that a new administrative process

would yield a different result before it could accept a ratification.

Pls.’ Mot. for Partial Summ. J. 30-31 (“Pls.’ MSJ”); Pls.’

Reply/Opp’n 25-27. But the Circuit did not create such a

stringent test in Legi-Tech. In explaining why requiring an

agency to redo the administrative process is not the correct

remedy, the Circuit merely noted that “[e]ven were the

Commission” to do so in that case, “it is virtually inconceivable

that its decisions would differ in any way the second time from

that which occurred the first time.” Legi-Tech, 75 F.3d at 708

(citing cases that explain that “remand to the agency is an

unnecessary formality where the outcome is clear”). The panel

was merely explaining why, in light of “human nature,” it would

not generally be the case that the result of a redo of the

administrative process would be different. Id. at 709. Based on

that understanding, the Circuit held that “return[ing] to square

one” is not required for an effective ratification. Id. at 708.

Appendix B-16

agencies to consider important aspects of the problem

before them. But Plaintiffs conflate ratification

doctrine with APA requirements prior to agency

action. This explains why their principal reliance on

Butte County v. Hogen, 613 F.3d 190, 194 (D.C. Cir.

2010), is misplaced. There, the Secretary of Interior

issued a final decision to take into trust land on which

an Indian tribe wished to conduct gaming operations

based on a years-old legal opinion by the Department’s

Solicitor, while ignoring more recent evidence offered

by the plaintiffs. The Circuit found that the Secretary

had violated the APA by not considering relevant

information before issuing his decision. See id. at 19495. Butte County says little about the effectiveness of

a ratification, however. Agency ratifications, which by

definition come after a final action has been taken, are

not governed by standard APA rules. As discussed,

“regardless of the type of administrative action,

[Circuit] decisions have consistently declined to

impose formalistic procedural requirements before a

ratification is deemed to be effective.” State Nat’l

Bank, 197 F. Supp. 3d at 184.

It bears noting that the effective ratification of the

Deeming Rule does not prevent Plaintiffs from

petitioning the FDA to repeal or amend the rule in

light of the intervening studies. See 5 U.S.C. § 553(e)

(“Each agency shall give an interested person the

right to petition for the issuance, amendment, or

repeal of a rule.”); cf. CTS Corp. v. EPA, 759 F.3d 52,

65 (D.C. Cir. 2014) (denying review based on the

inability to comment on post-promulgation studies

being added to the final record because plaintiff “could

have petitioned the EPA for either reconsideration or

a new rulemaking, or to reopen the notice-andcomment period.”). If Plaintiffs are not satisfied with

Appendix B-17

the agency’s response, they can seek judicial review.

See id. §§ 702, 706; see also Shipbuilders Council of

Am. v. United States, 868 F.2d 452, 456 (D.C. Cir.

1989) (“The denial of . . . a [section 553(e)] petition is

subject to judicial review, provided that the petitioner

can establish the requisite article III standing.”).

In any case, the studies cited by Plaintiffs do not

give the Court pause about whether a new notice-andcomment period would have yielded different results.

See Doolin, 139 F.3d at 212-13.4 The FDA considered

studies that purported to show that e-cigarettes may

be effective as smoking cessation devices and

healthier in some respects than conventional

cigarettes. But it nevertheless concluded that ecigarettes “clearly have the potential to increase

tobacco use and net health costs for the public as a

whole.” Nicopure Labs, 944 F.3d at 275 (citing 81 Fed.

Reg. at 29,038). It is that ultimate conclusion which

led the FDA to deem e-cigarettes subject to the

Tobacco Control Act. Though the new studies

Plaintiffs raise here may add to the quantum of

evidence, there is no indication whatsoever that they

alone would have upset the balance struck by the

agency.

Finally, Plaintiffs have failed to show any

“‘continuing prejudice’ from the [alleged] violations.”

Wilkes-Barre, 857 F.3d at 372 (quoting Legi-Tech, 75

F.3d at 708-09). The Court will not presume that any

4 Plaintiffs also cite the FDA’s adjustment of compliance dates as

evidence that a new rulemaking would yield a different result.

Pls.’ Reply/Opp’n 26-27. But while the Court does not discount

the importance of compliance deadlines to the industry, that the

FDA has extended them says little about whether it would

reissue the substantive aspects of the rule.

Appendix B-18

taint from the alleged Appointments Clause violation

continued after the rule was ratified. Legi-Tech, 75

F.3d at 708. And there is no indication that either of

the ratifiers were “biased” by the alleged improper

promulgation of the rule. See Legi-Tech, 75 F.3d at

709; Wilkes-Barre, 857 F.3d at 372. Without such a

showing, the Court may not look behind the decisionmaking process that led to the ratifications. It must

take them “at face value and treat [them] as an

adequate remedy” for any potential Appointments

Clause violation. Legi-Tech, 75 F.3d at 709.

The Court therefore finds the ratifications

effective.

b. Ratification is Resolution on the Merits

Plaintiffs contend that their Appointments

Clause challenge survives even if the ratifications

were effective. They argue that ratifications in actions

challenging a rulemaking merely moot the case

(rather than operate as a decision on the merits) and

that the voluntary-cessation exception to mootness

applies to the ratifications here. Pls.’ MSJ 37-40.

Plaintiffs maintain that because there is no guarantee

that the FDA will not simply continue its purportedly

illegal practice of having the ACP sign final rules, the

Court retains jurisdiction notwithstanding the

effectiveness of the ratifications.

Again, Plaintiffs run headlong into D.C. Circuit

precedent. The Circuit has “repeatedly held that a

properly appointed official’s ratification of an

allegedly improper official’s prior action, rather than

mooting a claim, resolves the claim on the merits by

remedying the defect (if any) from the initial

appointment.” Guedes v. Bureau of Alcohol, Tobacco,

Appendix B-19

Firearms and Explosives, 920 F.3d 1, 13 (D.C. Cir.

2019) (cleaned up); see e.g., Wilkes-Barre, 857 F.3d at

371 (reaffirming that “[r]atification can remedy

defects arising from the decisions of improperly

appointed officials”). That rule make sense. Whether

the FDA issues future rules through an improperly

appointed officer is irrelevant to whether the Deeming

Rule—the only rule challenged here—is valid. It is

valid because it was ratified. Yet to be promulgated

rules, that may or may not pose Appointments Clause

concerns and may or may not affect these Plaintiffs,

must await a different case. A challenge to them is too

speculative in nature to be considered in this suit.

Plaintiffs can (and should) raise potential

Appointments Clause violations to the agency during

such future rules’ notice-and-comment periods to give

the FDA the chance to confront any problems before

they materialize.

Plaintiffs attempt to distinguish the wellestablished principle that ratification resolves

Appointments Clause issues on the merits by

highlighting that the relevant D.C. Circuit opinions

all involved defenses to enforcement actions as

opposed to independent, pre-enforcement challenges.

Pls.’ MSJ 37-38. That difference, to Plaintiffs,

warrants rejecting the general rule and finding that

the ratifications here merely moot their claim. Id.

Plaintiffs primarily rely on the Guedes panel’s

discussion of ratification and mootness, id. (quoting

Guedes, 920 F.3d at 12-17), but they read Guedes too

far. That case involved President Trump’s

appointment of Acting Attorney General Whitaker

under the Federal Vacancies Reform Act, after

Attorney General Sessions resigned and before

Attorney General Barr was nominated and confirmed.

Appendix B-20

Guedes, 920 F.3d at 9. Although most of the

rulemaking process at issue took place under General

Sessions, it was Acting General Whitaker who signed

the final rule. After General Barr was confirmed, he

announced—similar to Commissioner Gottlieb here—

that he had “independently reevaluate[d]” the rule

and the “underlying rulemaking record” and that he

“personally c[a]me to the conclusion that it is

appropriate to ratify and affirm the final rule.” Id. at

9. The Guedes plaintiffs conceded that the ratification

was effective, and the Circuit held—on appeal of a

denial of preliminary injunctive relief—that “with

th[e] act of ratification and the concession, [the

plaintiff’s] likelihood of success on the merits of his

challenge to the rule based on Acting Attorney

General Whitaker’s role in its promulgation reduces to

zero.” Id. at 12 (emphasis added). The ratification

meant that the plaintiffs would be unable to succeed

on the merits because the ratification resolved the

merits of their pre-enforcement Appointments Clause

challenge. Full stop. Admittedly, the panel went on to

address in dicta why the claim still lacked a likelihood

of success even if they were to adopt the proposed

analytical approach that ratification merely moots a

claim. Id. at 14-17. But the panel assuredly did not

adopt that approach, and its belt-and-suspenders

mootness discussion does nothing to alter or

undermine its fundamental holding, which this Court

is bound to apply: Ratification resolves potential

Appointments Clause errors on the merits. Id. at 13.

B. The First Amendment

Plaintiffs also challenge the rule under the First

Amendment. E.g. Moose Jooce Compl. ¶¶ 54-57. They

argue that the FDA’s premarket review of e-cigarettes

Appendix B-21

that purport to reduce harm or the risk of disease is

an impermissible restriction on commercial speech

because it puts the burden on speakers (i.e., ecigarette manufacturers) to prove that their

marketing materials are truthful and not misleading.

E.g. Moose Jooce Compl. ¶¶ 55-56. The Court stayed

the briefing on the First Amendment arguments

pending the D.C. Circuits ruling in a case raising

almost identically arguments. Once the Circuit issued

that ruling in early December 2019, see Nicopure

Labs, 944 F.3d 267 (D.C. Cir. 2019), the Court sought

the views of the parties on whether Plaintiffs’

arguments were now foreclosed or required further

briefing. The parties disagreed on how to proceed:

Plaintiffs argued that further briefing is required,

while Defendants argued that Nicopure Labs resolved

Plaintiffs’ arguments.

The Court concludes that Nicopure Labs

forecloses Plaintiffs’ First Amendment claim.

Plaintiffs maintain that Nicopure Labs is

distinguishable because it merely “give[s] FDA the

power to prohibit truthful, non-misleading speech if

such speech is determined not to significantly reduce

harm or to benefit the general public health” but does

not “address[] at all the constitutionality of the Act’s

placement of the burden of proof entirely on the

manufacturer-speaker, which is the focus of Plaintiffs’

First Amendment claim.” JSR, at 5. The Court

disagrees. The Circuit expressly held that “[p]lacing

an obligation on a manufacturer to demonstrate that

an e-cigarette is in fact safer before it may market it

as such easily” passes First Amendment scrutiny.

Nicopure Labs, 944 F.3d at 284; see also id. at 288

(rejecting several industry arguments that it claimed

FDA did not adequately considered because “[e]ach of

Appendix B-22

those suggestions seeks to place the onus on the

government, rather than the manufacturers”). The

Circuit quite clearly held that placing the burden on

manufacturers to substantiate their marketing claims

does not violate the First Amendment. Bound by that

precedent, the Court holds that the Tobacco Control

Act’s premarket review provisions do not

impermissibly burden speech.

IV. Conclusion

For the foregoing reasons, the Court will deny

Plaintiff’s Motion for Partial Summary Judgement

and grant the FDA’s Cross-Motion for Partial

Summary Judgment on the Appointments Clause

claim. The Court will also, sua sponte, grant Summary

Judgment for the FDA on Plaintiffs’ First Amendment

Claim. A separate Order shall accompany this

memorandum opinion.

s/ Christopher R. Cooper

CHRISTOPHER R. COOPER

United States District Judge

Date: February 11, 2020

Appendix C-1

Filed 02/11/2020

UNITED STATES DISTRICT COURT

FOR THE DISTRICT OF COLUMBIA

MOOSE JOOCE, et al.,

Plaintiffs,

v.

FOOD AND DRUG

ADMINISTRATION,

et al.,

Case No. 18-cv-203

(CRC)

Defendants.

RAVE SALON, INC.

d/b/a JOOSIE VAPES,

Plaintiff,

v.

FOOD AND DRUG

ADMINISTRATION,

et al.,

Case No. 18-cv-1615

(CRC)

Defendants.

JEN HOBAN

d/b/a MASTERPIECE

VAPORS, et al.,

Plaintiffs,

v.

FOOD AND DRUG

ADMINISTRATION,

et al.,

Defendants.

Case No. 19-cv-372

(CRC)

Appendix C-2

ORDER

For the reasons stated in the accompanying

Memorandum Opinion, it is hereby

ORDERED that [26] Plaintiffs’ Motion for

Partial Summary Judgment is DENIED. It is further

ORDERED that [28] Defendants’ Cross-Motion

for Partial Summary Judgment is GRANTED on the

Appointments Clause Claim. It is further

ORDERED that Partial Summary Judgment is

GRANTED, sua sponte, for Defendants on the First

Amendment Claim.

This is a final appealable Order.

SO ORDERED.

s/ Christopher R. Cooper

CHRISTOPHER R. COOPER

United States District Judge

Date: February 11, 2020

Appendix D-1

U.S Const. art. II, § 2, cl. 2

He shall have Power, by and with the Advice and

Consent of the Senate, to make Treaties, provided two

thirds of the Senators present concur; and he shall

nominate, and by and with the Advice and Consent of

the Senate, shall appoint Ambassadors, other public

Ministers and Consuls, Judges of the supreme Court,

and all other Officers of the United States, whose

Appointments are not herein otherwise provided for,

and which shall be established by Law: but the

Congress may by Law vest the Appointment of such

inferior Officers, as they think proper, in the

President alone, in the Courts of Law, or in the Heads

of Departments.

21 U.S.C. § 387a(b)

(b) Applicability

This subchapter shall apply to all cigarettes,

cigarette tobacco, roll-your-own tobacco, and

smokeless tobacco and to any other tobacco products

that the Secretary by regulation deems to be subject

to this subchapter.

21 U.S.C. § 387j(a)(2)

(a) In general

*

*

*

*

*

(2) Premarket review required

(A) New products

An order under subsection (c)(1)(A)(i) for a new

tobacco product is required unless—

Appendix D-2

(i) the manufacturer has submitted a report

under section 387e(j) of this title; and the Secretary

has issued an order that the tobacco product—

(I) is substantially equivalent to a

tobacco product commercially marketed (other than

for test marketing) in the United States as of

February 15, 2007; and

(II) is in compliance with the requirements of this chapter; or

(ii) the tobacco product is exempt from the

requirements of section 387e(j) of this title pursuant

to a regulation issued under section 387e(j)(3) of this

title.

(B) Application to certain post-February 15, 2007,

products

Subparagraph (A) shall not apply to a tobacco

product—

(i) that was first introduced or delivered for

introduction into interstate commerce for commercial

distribution in the United States after February 15,

2007, and prior to the date that is 21 months after

June 22, 2009; and

(ii) for which a report was submitted under

section 387e(j) of this title within such 21-month

period,

except that subparagraph (A) shall apply to the

tobacco product if the Secretary issues an order that

the tobacco product is not substantially equivalent.

Appendix D-3

21 U.S.C. § 387k(b)(2)(A)

(b) Definitions

*

*

*

*

*

(2) Sold or distributed

(A) In general

With respect to a tobacco product, the term “sold or

distributed for use to reduce harm or the risk of

tobacco-related disease associated with commercially

marketed tobacco products” means a tobacco

product—

(i) the label, labeling, or advertising of

which represents explicitly or implicitly that—

(I) the tobacco product presents a

lower risk of tobacco-related disease or is less harmful

than one or more other commercially marketed

tobacco products;

(II) the tobacco product or its smoke

contains a reduced level of a substance or presents a

reduced exposure to a substance; or

(III) the tobacco product or its smoke

does not contain or is free of a substance;

(ii) the label, labeling, or advertising of

which uses the descriptors “light”, “mild”, or “low” or

similar descriptors; or

(iii) the tobacco product manufacturer of

which has taken any action directed to consumers

through the media or otherwise, other than by means

of the tobacco product’s label, labeling, or advertising,

after June 22, 2009, respecting the product that would

be reasonably expected to result in consumers

Appendix D-4

believing that the tobacco product or its smoke may

present a lower risk of disease or is less harmful than

one or more commercially marketed tobacco products,

or presents a reduced exposure to, or does not contain

or is free of, a substance or substances.

21 C.F.R. § 1100.1

In addition to FDA’s authority over cigarettes,

cigarette tobacco, roll-your-own tobacco, and

smokeless tobacco, FDA deems all other products

meeting the definition of tobacco product under

section 201(rr) of the Federal Food, Drug, and

Cosmetic Act, except accessories of such other tobacco

products, to be subject to the Federal Food, Drug, and

Cosmetic Act.

21 C.F.R. § 1100.2

Cigarettes, cigarette tobacco, roll-your-own

tobacco, smokeless tobacco are subject to chapter IX of

the Federal Food, Drug, and Cosmetic Act and its

implementing regulations. FDA has deemed all other

tobacco products, except accessories of such other

tobacco products, subject to chapter IX of the Federal

Food, Drug, and Cosmetic Act and its implementing

regulations.

Appendix E-1

81 FR 28973-01, 81 FR 28973-01,

2016 WL 2625201(F.R.)

RULES and REGULATIONS

DEPARTMENT OF HEALTH

AND HUMAN SERVICES

Food and Drug Administration

21 CFR Parts 1100, 1140, and 1143

[Docket No. FDA-2014-N-0189]

RIN 0910-AG38

Deeming Tobacco Products To Be Subject to the

Federal Food, Drug, and Cosmetic Act, as

Amended by the Family Smoking Prevention and

Tobacco Control Act; Restrictions on the Sale and

Distribution of Tobacco Products and Required

Warning Statements for Tobacco Products

Tuesday, May 10, 2016

AGENCY: Food and Drug Administration, HHS.

*28974 ACTION: Final rule.

SUMMARY: The Food and Drug Administration

(FDA) is issuing this final rule to deem products

meeting the statutory definition of “tobacco product,”

except accessories of the newly deemed tobacco

products, to be subject to the Federal Food, Drug, and

Cosmetic Act (the FD&C Act), as amended by the

Family Smoking Prevention and Tobacco Control Act

(Tobacco Control Act). The Tobacco Control Act

provides FDA authority to regulate cigarettes,

cigarette tobacco, roll-your-own tobacco, smokeless

tobacco, and any other tobacco products that the

Agency by regulation deems to be subject to the law.

With this final rule, FDA is extending the Agency’s

“tobacco product” authorities in the FD&C Act to all

other categories of products that meet the statutory

Appendix E-2

definition of “tobacco product” in the FD&C Act,

except accessories of such newly deemed tobacco

products. This final rule also prohibits the sale of

“covered tobacco products” to individuals under the

age of 18 and requires the display of health warnings

on cigarette tobacco, roll-your own tobacco, and

covered tobacco product packages and in

advertisements. FDA is taking this action to reduce

the death and disease from tobacco products. In

accordance with the Tobacco Control Act, we consider

and intend the extension of our authorities over

tobacco products and the various requirements and

prohibitions established by this rule to be severable.

DATES: This rule is effective August 8, 2016. See

section IV of this document regarding compliance

dates for certain provisions.

*

*

*

*

*

Dated: May 3, 2016.

Leslie Kux,

Associate Commissioner for Policy.

[FR Doc. 2016-10685 Filed 5-5-16; 8:45 am]

Appendix F-1

U.S. FOOD & DRUG

ADMINISTRATION

April 3, 2019

On May 10, 2016, the Food and Drug Administration

published in the Federal Register a final rule entitled

“Deeming Tobacco Products To Be Subject to the

Federal Food, Drug, and Cosmetic Act, as Amended by

the Family Smoking Prevention and Tobacco Control

Act; Restrictions on the Sale and Distribution of

Tobacco Products and Required Warning Statements

for Tobacco Products,” 81 Fed. Reg. 28,974 (the

“Deeming Rule”). The authority under which the

Deeming Rule was issued has been questioned in

litigation. To resolve these questions, I hereby affirm

and ratify the Deeming Rule as of the date it was

published in the Federal Register on May 10, 2016,

including all regulatory analysis certifications

contained therein. I undertake this action based on

my careful review of the rule, my knowledge of its

provisions, and my close involvement in policy

matters relating to this rule and its implementation,

as well as its public health importance. This action is

not intended to suggest any legal defect or infirmity in

the promulgation of the Deeming Rule.

s/ Scott Gottlieb MD

Scott Gottlieb, M.D.

Commissioner of Food and Drugs

Appendix F-2

State of Maryland

Montgomery County

On this 3rd day of April Scott Gottlieb personally

appeared before me and acknowledged that he/she

executed the foregoing instrument.

s/ Marguerite Constable

Notary Public

My commission expires: Jan. 10, 2021

U.S. Food & Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993

Appendix G-1

DEPARTMENT OF HEALTH AND HUMAN

SERVICES

Public Health Service

Food and Drug Administration

Silver Spring, MD 20993

DATE:

21 September 2016

TO:

See Recipient List

FROM:

Commissioner of Food and Drugs

SUBJECT: Delegation of Authority for General

Redelegations of Authority from the

Commissioner to Other Officers of the

Food

and

Drug

Administration

(referenced in SMG 1410.21)

I am approving this delegation to amend the

previous version.

1. AUTHORITIES DELEGATED

WHOM DELEGATED.

AND

TO

A. Final authority of the Commissioner of Food

and Drugs (Commissioner) is redelegated as

referenced in the 1410 series of the Agency’s

Staff

Manual

Guides

(SMGs).

The

Commissioner may continue to exercise all

delegated authority referenced in these SMGs

B. The following officials are authorized to

perform all delegable functions of the

Commissioner. These officials may not further

redelegate this authority, or any part of this

authority, except as elsewhere specified:

1) Deputy Commissioner for Medical Products

and Tobacco, Office of Medical Products and

Tobacco (OMPT).

Appendix G-2

2) Chief of Staff, Office of the Commissioner

(OC)

3) Deputy Commissioner for Operations and

Chief Operating Officer, Office of Operations

(OO)

4) Deputy Commissioner for Policy, Planning,

Legislation and Analysis, Office of Policy,

Planning, Legislation and Analysis (OPPLA)

5) Deputy Commissioner for Foods and

Veterinary Medicine, Office of Foods and

Veterinary Medicine (OFVM)

6) Deputy Commissioner for Global Regulatory

Operations and Policy, Office of Global

Regulatory Operations and Policy (OGROP)

7) Chief Scientist, Office of the Chief Scientist

(OCS), OC

8) Associate Commissioner for Regulatory

Affairs, Office of Regulatory Affairs (ORA),

OGROP.

C. The Federal Vacancies Reform Act of 1998

(Vacancies Reform Act) applies if the

Commissioner dies, resigns, or is otherwise

unable to perform the functions and duties of

the Office of the Commissioner.

1) During an absence of the Commissioner that

does not trigger the requirements of the

Vacancies Reform Act, the first official in the

following order who is available, or the official

in the following list who has been designated

by the Commissioner, to act shall lead the

Agency (specific delegations provided below

do not limit the general delegations provided

Appendix G-3

by this section to the designated officials who

are authorized to perform all of -the delegable

functions of the Commissioner):

a. Deputy Commissioner for

Veterinary Medicine, OFVM.

Foods

and

b. Deputy Commissioner for Medical Products

and Tobacco, (OMPT).

c. Chief of Staff, OC.

d. Deputy Commissioner for Operations and

Chief Operating Officer, OO.

e. Deputy Commissioner for Policy, Planning,

Legislation and Analysis, OPPLA.

f. Deputy Commissioner for Global Regulatory

Operations and Policy, OGROP.

g. Chief Scientist, OCS, OC.

h. Associate Commissioner for Regulatory

Affairs, ORA, OGROP.

i. Director, Center for Drug Evaluation and

Research (CDER), OMPT.

2) When the Vacancies Reform Act applies, the

Deputy Commissioner for Foods and

Veterinary Medicine, OFVM, shall act as

Commissioner

unless

the

Deputy

Commissioner for Foods and Veterinary

Medicine, OFVM, does not meet the

requirements of the Vacancies Reform Act or

the President has directed someone else to act

as Commissioner pursuant to the Vacancies

Reform Act.

Appendix G-4

D. Authority delegated to a position by title may

be exercised by a person officially designated to

serve in that position in an acting capacity or

on a temporary basis, unless prohibited by a

restriction in the document designating them

as “acting” or unless not legally permissible.

E. The following officials are authorized to

perform all the functions of the officials under

them in their respective offices and they may

not further redelegate this authority:

1) Deputy Commissioner for Medical Products

and Tobacco, OMPT.

2) Deputy Commissioner for Operations and

Chief Operating Officer, OO.

3) Chief Scientist, OCS, OC.

4) Deputy Commissioner for

Veterinary Medicine, OFVM.

Foods

and

5) Deputy Commissioner for Global Regulatory

Operations and Policy, OGROP.

6) Associate Commissioner

Affairs, ORA, OGROP.

for

Regulatory

7) Chief Counsel, Office of the Chief Counsel.

8) Deputy Commissioner for Policy, Planning,

Legislation and Analysis, OPPLA.

F. The Deputy Commissioner for Medical

Products and Tobacco, OMPT is authorized:

1) To make determinations that advisory

committee meetings are concerned with

matters listed in 5 U.S.C. 552(b) and therefore

may be closed to the public in accordance with

Appendix G-5

Title 21, Code of Federal Regulations (21

CFR) 14.27.

2) To perform other associated advisory

committee functions, e.g., establishing

technical and scientific review groups

(advisory committees); appointing and paying

members; approving waivers to appoint

members to established advisory committees;

renewing and rechartering of established

advisory committees; amending charters of

established

advisory

committees;

and

terminating established advisory committees.

3) To approve conflict of interest waivers for

Special Government Employees (SGEs) and

regular government employees serving on

advisory committees in accordance with 21

U.S.C. 379d-1 and 18 U.S.C. 208(b)1 and

208(b)(3), as amended.

4) To select temporary members to advisory

committees if such voting members are

serving on an advisory committee managed by

another Center.

5) To issue Federal Register (FR) Notices

relating to advisory committee activities.

6) To further redelegate the authorities in

paragraphs F.1-F.5 above to the Associate

Commissioner for Special Medical Programs,

Office of Special Medical Programs (OSMP),

OMPT. In addition, in the event of absence or

a vacancy in the position, the Deputy

Commissioner

for

Policy,

Planning,

Legislation and Analysis, OPPLA, is

Appendix G-6

designated to perform the functions in

paragraphs F.1.-F.5 above.

7) Under Section 503(g)(4)(E)(ii) of the Federal,

Food, Drug and Cosmetic Act (FFDCA), as

added by Section 204 of the Medical Device

User Fee Modernization Act of 2002

(MDUFMA), with respect to combination

products the following: “During the review

process, any dispute regarding the substance

of premarket review may be presented to the

Commissioner of Food and Drugs after first

being considered by the Agency Center with

primary jurisdiction of the premarket review,

under the scientific dispute resolution

procedures

for

such

Center.

The

Commissioner of Food and Drugs shall

consult with the Director of the Office of

Combination Products, OSMP, OMPT in

resolving the substantive dispute.”

G. The Deputy Commissioner for Policy, Planning,

Legislation and Analysis, OPPLA, the

Associate Commissioner for Policy, Office of

Policy (OP), OPPLA, and the Associate

Commissioner for Public Health Strategy and

Analysis, Office of Public Health Strategy and

Analysis (OPHSA), OPPLA, are authorized:

1) To perform any of the functions of the

Commissioner with respect to the issuance of

FR notices and proposed and final regulations

of the Food and Drug Administration. This

authority may not be further redelegated.

2) To issue responses to the following matters

under part 10 of 21 CFR as follows and these

Appendix G-7

officials may not further redelegate this

authority:

a. Requests for waiver, suspension, or

modification of procedural requirements

under Section 10.19 of 21 CFR.

b. Citizen petitions under Section 10.30 of 21

CFR.

c. Petitions for reconsideration under Section

10.33 of 21 CFR.

d. Petitions for stay under Section 10.35 of 21

CFR.

e. Requests for advisory

Section 10.85 of 21 CFR.

opinions

under

3) With respect to any matter delegated to the

Deputy Commissioner for Policy, Planning,

Legislation and Analysis, OPPLA, the

Associate Commissioner for Policy, OP,

OPPLA, and the Associate Commissioner for

Public Health Strategy and Analysis,

OPHSA, OPPLA, under this paragraph, the

Deputy Commissioner for Policy, Planning,

Legislation and Analysis, OPPLA, the

Associate Commissioner for Policy, OP,

OPPLA, and the Associate Commissioner for

Public Health Strategy and Analysis,

OPHSA, OPPLA, are authorized to perform

the functions of the Commissioner under

Section 10.40, 10.45, 10.50, 10.55, 10.60,

10.65, 10.80, 10.90, and 10.95 of 21 CFR and

of a Deputy Commissioner under Section

10.206(g) and (h) of 21 CFR. These authorities

may not be further redelegated.

Appendix G-8

4) Under the Regulatory Flexibility Act (5

U.S.C. 605(b)) to certify that a proposed or

final rule, if issued, will not have a significant

economic impact on a substantial number of

small entities. The Deputy Commissioner for

Policy, Planning, Legislation and Analysis,

OPPLA, the Associate Commissioner for

Policy, OP, OPPLA, and the Associate

Commissioner for Public Health Strategy and

Analysis, OPHSA, OPPLA, may further

redelegate this authority.

5) To make all determinations and findings

under 21 CFR Part 15, and to waive, suspend,

or modify any procedural requirements

related to Part 15 under Section 10.19 of 21

CFR.

H. The Associate Director for Policy, Office of

Policy,

CDER,

OMPT,

is

Regulatory

authorized:

1) To waive or reduce prescription drug user fees

in situations where he or she finds that such

a waiver or reduction: (1) is necessary to

protect the public health under Section

736(d)(1)(A) of the FFDCA (21 U.S.C.

379h(d)(1)(A)), as amended; (2) is necessary

because the fee would present a significant

barrier to innovation under Section

736(d)(1)(B) of the FFDCA (21 U.S.C.

379h(d)(1)(a)), as amended; or (3) is

appropriate under Section 736(d)(1)(D) of the

FFDCA (21 U.S.C. 379h(d)(1)(D)), as

amended because the applicant involved is a

small business submitting its first human

Appendix G-9

drug application. These authorities may not

be further redelegated.

2) To act upon requests for consideration of any

user fee decisions under Section 735 of the

FFDCA (21 U.S.C. 379h), other than decisions

on fee-exceed-the ·cost waiver requests, made

by such officers and the former Deputy User

Fee Waiver Officer prior to July 1, 1999.

These authorities may not be further

redelegated.

I.

The Director, Policy and Regulations Staff,

Office of the Center Director, Center for

Veterinary Medicine (CVM), OFVM is

authorized:

1) To waive or reduce animal drug user fees in

situations where he or she finds that such a

waiver or reduction: (1) is necessary because

the fee would present a significant barrier to

innovation under Section 740(d)(1)(A) of the

FFDCA (21 U.S.C. 379j-12(d)(1)(A)), as

amended; (2) is necessary because the drug

application or supplemental application is

intended solely for use of the animal drug in

medicated feeds under Section 740(d)(1)(C) of

the FFDCA (21 U.S.C. 379j-12(d)(1)(C)), as

amended; (3) is necessary because the animal

drug application or supplemental animal

drug application is intended solely to provide

for minor use or minor species indications

under Section 740(d)(1)(D) of the FFDCA (21

U.S.C. 379j-12(d)(1)(0)), as amended; or (4) is

appropriate under Section 740(d)(1)(E) of the

FFDCA (21 U.S.C. 379h(d)(1)(E)), as

amended because the applicant involved is a

Appendix G-10

small business submitting its first animal

drug application. This authority may not be

redelegated.

2) To waive or reduce generic animal drug user

fees in situations where he or she finds that

such a waiver or reduction is necessary

because the animal drug application or

supplemental animal drug application is

intended solely to provide for minor use or

minor species indications under Section

741(d) of the FFDCA (21 U.S.C. 379j-21(d)), as

amended.

3) Under any of the above cited provisions of

Section 740 and 741 of the FFDCA, to act

upon requests for reconsideration of decisions

made. This authority may not be redelegated.

J.

The Associate Director for Policy and

Communications, Office of the Director, CVM,

OFVM, is authorized to act upon requests for

reconsideration of decisions made under any

provision of Sections 740 and 741 of the

FFDCA, except for those decisions that pertain

to fee-exceed-the cost waiver requests. This

authority may not be further redelegated.

K. The Deputy Commissioner for Operations and

Chief Operating Officer, OO, is authorized to

perform the functions of the Commissioner

under:

1) Section 736(d)(1)(c) of the FFDCA (21 U.S.C.

379h(d)(1)(C)), as amended, to waive or

reduce prescription drug user fees in

situations where he or she finds that “the fees

will exceed the anticipated present and future

Appendix G-11

costs.” The Deputy Commissioner for

Operations and Chief Operating Officer, OO,

may further redelegate the authority in this

paragraph in whole or in part to the Associate

Commissioner for Finance, Budget and

Acquisitions, Office of Finance, Budget and

Acquisitions (OFBA), OO.

2) Section 740(d)(1)(B) of the FFDCA, to waive

or reduce animal drug user fees, for waiver or

reduction requests made on the basis that the

fees assessed exceed the costs to FDA for

reviewing

applications.

The

Deputy

Commissioner for Operations and Chief

Operating Officer, OO, may further

redelegate the authority in this paragraph in

whole or in part to the Associate

Commissioner for Finance, Budge [sic] and

Acquisitions, OFBA, OO.

3) Section 736(c)(4) of the FFDCA, as amended

by the Prescription Drug User Fee Act

Amendments

of

2002,

to

establish

application, product, and establishment fees

under Section 736(a), based on the revenue

amounts established under Section 736(b)

and the adjustments under 736(c). The

Deputy Commissioner for Operations and

Chief Operating Officer, OO, may further

redelegate the authority in this paragraph in

whole or in part to the Associate

Commissioner for Finance, Budget and

Acquisitions, OFBA, OO.

4) Section 738 of the FFDCA, as added by the

MDUFMA, to adjust and set fee rates for

medical device applications each year. The

Appendix G-12

Deputy Commissioner for Operations and

Chief Operating Officer, OO, may further

redelegate the authority in this paragraph in

whole or in part to the Associate

Commissioner for Finance, Budget and

Acquisitions, OFBA, OO.

5) Section 740(c)(4) of the FFDCA, to adjust and

set new and supplemental animal drug

application fees, animal drug sponsor fees,

animal drug product fees, and animal drug

establishment

fees.

The

Deputy

Commissioner for Operations and Chief

Operating Officer, OO, may further

redelegate the authority in this paragraph in

whole or in part to the Associate

Commissioner for Finance, Budget and

Acquisitions, OFBA, OO.

6) Section 741(c)(3) of the FFDCA, to adjust and

set abbreviated application fees, generic new

animal drug sponsor fees, and generic new

animal drug product fees. The Deputy

Commissioner for Operations and Chief

Operating Officer, OO, may further

redelegate the authority in this paragraph in

whole or in part to the Associate

Commissioner for Finance, Budget and

Acquisitions, OFBA, OO.

7) Section 919(b)(6)) [sic] of the FFDCA (21

U.S.C.

387s(c)(6)),

to

notify

each

manufacturer and importer of tobacco

products subject to this Section of the amount

of the quarterly assessment due for such

products. The Deputy Commissioner for

Operations and Chief Operating Officer, OO,

Appendix G-13

may further redelegate the authority in this

paragraph in whole or in part to the Associate

Commissioner for Finance, Budget and

Acquisitions, OFBA, OO.

8) Under any fees-exceed-cost user fee waiver or

reduction sections of the FFDCA noted above,

act upon requests for reconsideration of

decisions made by such officers. This

authority may not be redelegated.

L. The Chief Scientist, OCS, OC, is designated as

the User Fee Appeals Officer. The User Fee

Appeals Officer is authorized to hear and decide

user fee waiver appeals. The decision of the

User Fee Appeals Officer will constitute final

agency action on such matters. The User Fee

Appeals Officer may not further redelegate this

authority.

M. The Deputy Commissioner for Operations and

Chief Operating Officer, OO, is authorized to

perform all of the administrative authorities

(i.e.,

financial,

personnel,

facilities

management, property management, etc.) of

the Commissioner. These authorities may be

further redelegated, except when specifically

prohibited.

N. The following officials are authorized to deny a

request to issue an emergency use

authorization (EUA) under Section 564 of the

FFDCA, and to consult under Section 564(c) of

the FFDCA, requiring “consultation with the

Director of the National Institutes of Health

and the Director of the Centers for Disease

Control and Prevention (to the extent feasible

Appendix G-14

and appropriate given the circumstances of the

emergency involved)” prior to issuing an EUA:

1) Chief Scientist, OCS, OC.

2) Deputy Commissioner for Medical Products

and Tobacco, OMPT.

3) Director, Center for Biologics Evaluation and

Research (CBER), OMPT.

4) Director, Center for Drug Evaluation and

Research (CDER), OMPT.

5) Director, Center for Devices and Radiological

Health (CDRH), OMPT.

O. The following officials are authorized to issue

the final decision regarding the disqualification

of a clinical investigator, i.e., the investigator’s

eligibility to receive investigational articles

under 21 CFR 312.70(b), 511.1(c)(2), or

812.119(b):

1) Deputy Commissioner for Medical Products

and Tobacco, OMPT.

2) Chief Scientist, OCS, OC.

3) Associate Commissioner for Special Medical

Programs, OMPT.

P. The following officials are authorized to sign a

consent agreement between the FDA and a

clinical

investigator

regarding

the

disqualification of the clinical investigator,

resulting in the clinical investigator’s

ineligibility to receive investigational articles

under 21 CFR 312.70(b), 511.1(c)(2), or

812.119(b) and containing a binding provision

that disqualification pursuant to the consent

Appendix G-15

agreement has the same legal effect as being

disqualified pursuant to the relevant regulation

after a Part 16 Hearing. These officials may not

further redelegate this authority.

1) Director, CBER, OMPT.

2) Director and Deputy Director, Office of

Compliance and Biologics Quality (OCBQ),

CBER, OMPT.

3) Director, CDER, OMPT.

4) Director and Deputy Director, Office of

Compliance (OC), CDER, OMPT.

5) Director and Deputy Director, Division of

Scientific Investigations (DSI), OC, CDER,

OMPT.

6) Director, CVM, OFVM.

7) Director and Deputy Director, Office of

Surveillance and Compliance (OSC), CVM,

OFVM.

8) Director, Division of Compliance, OSC, CVM,

OFVM.

9) Director, CDRH, OMPT.

10) Deputy Director for Science, CDRH, OMPT.

11) Director, Office of Compliance (OC), CDRH,

OMPT.

12) Deputy Director for Medical Affairs, OC,

CDRH, OPMT.

2. RE-DELEGATION.

Except as otherwise provided, these Officials may

not further redelegate these authorities.

Appendix G-16

3. EFFECTIVE DATE.

A. These delegations become effective upon date of

signature.

B. In addition, I hereby ratify and affirm any

actions taken by you or your subordinate(s),

which in effect involved the exercise of the

authorities delegated herein prior to the

effective date of this delegation.

s/ Robert M. Califf

Robert M. Califf, M.D.

Commissioner of Food and Drugs

Recipients:

• Chief Counsel, OCC, OC

• Chief Scientist, OCS, OC

• Deputy Commissioner for Foods and Veterinary

Medicine, OFVM

• Deputy Commissioner for Global

Operations and Policy, OGROP

Regulatory

• Deputy Commissioner for Medical Products and

Tobacco, OMPT

• Deputy Commissioner for Operations and Chief

Operating Officer, OO

• Deputy Commissioner for Policy,

Legislation and Analysis, OPPLA

Planning,

• Associate Commissioner for Regulatory Affairs,

ORA, OGROP

• Associate Commissioner

Programs, OMPT

for

Special

Medical

Appendix G-17

• Associate Commissioner for External Affairs, OEA,

OC

• Center Directors

• Center Executive Officers

• Component Delegation Control Officers

• Principal Delegation Control Officer