Exemption From Preemption of State and Local Cigarette and Smokeless Tobacco Requirements; Applications for Exemption Submitted by Various State Governments

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 808

[Docket No. 96N-0249]

RIN 0910-AB19

Exemption From Preemption of State and Local Cigarette and

Smokeless Tobacco Requirements; Applications for Exemption Submitted by

Various State Governments

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is granting exemptions

from Federal preemption for certain cigarette and smokeless tobacco

requirements in Alabama, Alaska, and Utah. These exemptions will permit

those States to continue to enforce certain restrictions on the sale

and distribution of cigarettes and smokeless tobacco that are more

stringent than FDA counterpart restrictions under its regulations.

EFFECTIVE DATE: December 29, 1997.

FOR FURTHER INFORMATION CONTACT: Anne M. Kirchner, Office of Policy

(HF-11), Food and Drug Administration, 5600 Fishers Lane, Rockville, MD

20857, 301-827-5321.

SUPPLEMENTARY INFORMATION:

I. Background

Under section 521(a) of the Federal Food, Drug, and Cosmetic Act

(the act) (21 U.S.C. 360k(a)), any State or local requirement

applicable to a device is preempted if such requirement: (1) Is

different from, or in addition to, any requirement applicable under the

act to the device; and (2) relates to the safety or effectiveness of

the device or any

[[Page 63272]]

other matter included in a requirement applicable to the device under

the act.

In implementing section 521 of the act, FDA historically has

interpreted that provision narrowly and has found it to have preemptive

effect only for those State and local requirements that, in fact,

clearly impose specific requirements with respect to specific devices

that are manifestly in addition to analogous Federal requirements (see

Sec. 808.1(d) (21 CFR 808.1(d)). In addition, section 521 of the act

``does not preempt State or local requirements that are equal to, or

substantially identical to, requirements imposed by or under the act''

(Sec. 808.1(d)(2)).

Section 521(b) of the act and its implementing regulations provide

that by regulation issued after notice and an opportunity for an oral

hearing, FDA may exempt a State or local requirement from preemption

under such conditions as the agency may prescribe if the requirement

is: (1) More stringent than a requirement under the act that would be

applicable to the device if an exemption were not in effect; or (2)

required by compelling local conditions and compliance with the State

or local requirement would not cause the device to be in violation of

any requirement applicable under the act.

In the Federal Register of November 7, 1996 (61 FR 57685), FDA

invited all State and local governments to submit applications for

exemptions from preemption for those State and local requirements

pertaining to cigarettes and smokeless tobacco that are preempted by

the agency's final rule at part 897 (21 CFR part 897) restricting the

sale and distribution of cigarettes and smokeless tobacco to protect

children and adolescents, and that meet the exemption criteria. In

order to facilitate and expedite review, FDA stated that it would

consider applications in two groups. Group 1 applications are those

seeking exemptions from Federal preemption of State and local age and

identification requirements. Group 2 applications are those seeking

exemptions from Federal preemption of State and local access, labeling,

and advertising requirements.

This final rule responds to Group 1 applications for exemptions

from preemption for State and local requirements governing the sale and

distribution of cigarettes and smokeless tobacco that are different

from, or in addition to, FDA requirements under Sec. 897.14(a) and (b).

Section 897.14(a) prohibits the sale of cigarettes or smokeless tobacco

to any person under age 18. Section 897.14(b) requires that retailers

verify, by means of photographic identification containing the bearer's

birth date, that the person purchasing the product is at least 18 years

of age. No such verification is required for persons over the age of

26.

The November 1996, Federal Register notice stated that Group 1

applications should be submitted by December 9, 1996, and that Group 2

applications, for exemption from preemption from any of the

requirements under part 897 other than Sec. 897.14(a) and (b), should

be submitted by May 6, 1997 (61 FR 57685 at 57686).

In the Federal Register of February 19, 1997 (62 FR 7390), FDA

issued a proposed rule responding to Group 1 applications submitted by

the States of Alabama, Alaska, Utah, and Washington. The proposal gave

the public 30 days to submit written comments. The comment period later

was reopened for an additional 2 weeks (see 61 FR 11349, March 20,

1996).

FDA proposed to grant exemptions from Federal preemption for

requirements in the States of Alabama, Alaska, and Utah. Washington

State requirements were not preempted and, therefore, no exemption

needed to be granted. The Alabama Code, the Alaska Statutes, and the

Utah Code Annotated prohibit the sale of cigarettes or smokeless

tobacco to any person under the age of 19. The proposed rule explained

that these requirements are different from the age restriction

contained in the tobacco rule at Sec. 897.14(a), which prohibits sales

of cigarettes or smokeless tobacco to anyone under age 18. However, the

proposal stated FDA's tentative conclusion that the higher minimum age

for sale of these products will provide increased health benefits and

will not impose significant burdens on retailers. Therefore, to the

extent that these State requirements are preempted, FDA proposed to

grant them exemptions from preemption.

II. Request for a Hearing

FDA received one request for a hearing. Section 521(b) of the act

requires that FDA offer an opportunity for an oral hearing to present

evidence that the agency should consider before granting or denying

exemptions from preemption. The request for a hearing submitted under

this rulemaking raised only legal and policy issues that may be

addressed adequately without holding an oral hearing. Consequently,

consistent with FDA's regulation at 21 CFR 12.24(b), FDA is denying the

request. The legal and policy issues raised in the request for a

hearing are addressed in section III of this document.

III. Discussion of Comments

FDA received no comments about the agency's action concerning the

application submitted by the State of Washington for exemption from

Federal preemption for: (1) Section 26.28.080 of the Revised Code of

Washington (RCW)\1\, a State law prohibiting any person from selling or

giving tobacco products to persons younger than 18 years of age, and

(2) section 314-10-050 of the Washington Administrative Code (WAC)\2\,

a State regulation requiring that purchasers of tobacco products

provide proof of age by providing certain Government-issued forms of

identification. As discussed in the proposal (62 FR 7390 at 7393), FDA

determined that portions of the State of Washington statute and

regulations are narrower in scope than the tobacco rule and therefore

are not preempted. Because neither RCW 26.28.080 nor WAC 314-10-050

prohibits the distribution of free samples of cigarettes and smokeless

tobacco to persons 18 years or older, these provisions are less

stringent than the total prohibition against free samples in the

tobacco rule at Sec. 897.16(d). In addition, to the extent that the RCW

26.28.080 and WAC 314-10-050 apply to products other than cigarettes

and smokeless tobacco, they are not preempted by the tobacco rule

because the tobacco rule does not establish ``specific counterpart

[[Page 63273]]

regulations'' or other requirements with respect to products other than

cigarettes or smokeless tobacco (see Sec. 808.1(d)). Finally, WAC 314-

10-050 requires purchasers to present identification establishing the

purchaser's age and specifies requirements for the type of

identification that the purchaser must present. Because FDA has not

established any specific counterpart regulations that place an

affirmative duty on the purchaser to present identification or that

require a specific type of photographic identification containing the

bearer's birth date, WAC 314-10-050 is not preempted. Therefore,

because RCW 26.28.080 and WAC 314-10-050 are not preempted, no

exemption is necessary.

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\1\ RCW 26.28.080 Selling or giving tobacco to minor--Belief of

representative capacity, no defense--Penalty.

Every person who sells or gives, or permits to be sold or given

to any person under the age of eighteen years any cigar, cigarette,

cigarette paper or wrapper, or tobacco in any form is guilty of a

gross misdemeanor.

It shall be no defense to a prosecution for a violation of this

section that the person acted, or was believed by the defendant to

act, as agent or representative of another.

\2\ WAC 314-10-050 Sales to persons under 18 years of age.

(1) No person may sell or give or in any way provide tobacco

products to any person under 18 years of age.

(2) Any person attempting to purchase tobacco products must

present identification to show he/she is at least 18 years of age

upon the request of any tobacco licensee, employee of tobacco

licensee or enforcement officer as defined by RCW 7.8.040.

(3) All identification used to prove age must be officially

issued and contain the bearer's age, signature and photograph. The

only forms of identification which are acceptable as proof of age

for the purchase of tobacco products are:

(a) A liquor control authority card of identification issued by

a state of the United States or province of Canada,

(b) A driver's license, instruction permit or identification

card issued by a state of the United States or a province of Canada,

(c) A United States military identification card,

(d) A passport, or

(e) A merchant marine identification card issued by the United

States Coast Guard.

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FDA received 15 comments on the proposed rule. Notably, none of the

comments argued that FDA should deny the applications for exemption

from preemption submitted by Alabama, Alaska, or Utah. In fact, several

comments specifically urged that FDA grant these applications because

active enforcement of the higher minimum age for sale in the three

States has resulted in a decline in illegal sales of tobacco products

to underage youths.

The remaining comments, while supporting FDA's proposal to grant

exemptions from preemption for the Alabama, Alaska, and Utah

requirements, argued that FDA misinterpreted the scope of preemption

under 521(a) of the act by failing to find that all State and local

requirements that are less stringent than Federal counterpart

requirements are preempted. These comments urged FDA to reconsider its

analysis of the Supreme Court decision in Medtronic, Inc. v. Lohr, 116

S. Ct. 2240 (1996), in light of Papike v. Tambrands, 107 F.3d 737

(1997), and argued that the agency's interpretation of the narrow scope

of preemption under section 521(a) of the act would undermine State and

local efforts to promote public health. A few comments stated that more

stringent State or local restrictions should not be preempted because

they safeguard the public health more than Federal counterpart

restrictions do. Several comments argued that Medtronic is not

dispositive of the extent to which 521(a) of the act preempts State or

local tobacco control laws because the Medtronic Court determined

whether 521(a) preempts general common law duties, not whether 521(a)

would preempt a specific enactment of State or local law. Comments

noted that, because State tobacco statutes are positive enactments of

State law, they are precisely the type of requirement that is normally

preempted by specific FDA requirements.

Comments relied on the recent Ninth Circuit decision, Papike, to

support their interpretation of Medtronic and the scope of preemption

under 521(a) of the act. The Papike court held that section 521(a) of

the act preempts a State common law cause of action for failure to warn

because FDA has established specific counterpart labeling regulations

mandating the substantive content of the warning for the particular

device and disease at issue in that case. The Papike court

distinguished the case before it, which involved specific Federal

requirements applicable to a specific device, from Medtronic, which

involved general Federal requirements (good manufacturing practices and

labeling requirements). (See Papike at 740.) Applying the reasoning in

Papike, comments argued that specific Federal tobacco requirements

preempt specific, and less stringent, State or local counterpart

requirements.

FDA is not persuaded that it erred in its determination that 521(a)

of the act preempts more restrictive, but not less restrictive, State

or local counterpart requirements. First, FDA believes that the Supreme

Court in Medtronic has addressed the very issue of whether less

restrictive State or local requirements are preempted under section

521(a) of the act. As the agency stated in the proposed rule (62 FR

7390 at 7391), the Medtronic Court held that State requirements that

are similar to, but narrower than, FDA requirements are not preempted

under section 521 of the act. The Court reasoned that, while narrower

State restrictions might be ``different from'' their more stringent

Federal counterpart restrictions, ``* * * such a difference would

surely provide a strange reason for finding a pre-emption of a state

rule insofar as it duplicates the federal rule'' (Medtronic, 116 S.Ct.

at 2255). Accordingly, FDA concludes that section 521(a) of the act

does not preempt State or local restrictions to the extent that they

are similar to, but narrower or less stringent than, counterpart FDA

restrictions.

FDA disagrees with the comments' analysis of and reliance on

Papike. The agency agrees that a determination of whether a State or

Federal requirement is general or specific in nature is essential to

any analysis of preemption under section 521(a) of the act. That

determination, however, is not dispositive as to whether a particular

State or local requirement is preempted. Rather, if there are specific

Federal and State requirements applicable to the specific device at

issue, the next question is whether the State requirement is different

from, or in addition to, the Federal requirement. The Court in

Medtronic concluded that a State or local requirement that is narrower

than, or duplicative of, a counterpart Federal requirement, is not

``different from'' the Federal requirement and, consequently, is not

preempted under section 521(a) of the act.

Several comments argued that FDA weakened the standard by which a

narrower State or local requirement is found to be preempted. Medtronic

held that State requirements are not preempted if they parallel Federal

requirements or insofar as they duplicate Federal requirements (Id.).

In the proposed rule (62 FR 7390 at 7391), FDA paraphrased this holding

in stating that State or local requirements that are similar to, but

narrower than, counterpart Federal requirements are not preempted. FDA

believes that it has not weakened the Medtronic standard and that its

application of the standard articulated by the Supreme Court in

Medtronic is required by the Court's interpretation of the scope of

preemption under section 521 of the act.

Other comments argued that, as a matter of policy, the finding that

less stringent State or local requirements are not preempted weakens

FDA's tobacco rule and undermines State and local public health

initiatives to reduce tobacco use by children and adolescents.

First, the act clearly requires that a State or local enactment be

``different from,'' or ``in addition to'' a counterpart FDA requirement

to be preempted, and FDA regulations enumerate the types of evidence or

information that the agency will consider in determining whether to

grant an exemption from preemption (see 21 CFR part 808). While the

agency is always open to receiving information regarding its decisions,

including evidence that a State or local requirement impairs the

agency's ability to enforce its regulations, preemption does not occur

under section 521 of the act absent a showing that such a requirement

is ``different from,'' or ``in addition to,'' a specific counterpart

FDA requirement. Second, as a matter of policy, FDA believes that

States and localities are able to determine whether, in light of the

Supreme Court's interpretation of the scope of Federal preemption under

521(a) of the act, additional or new legislation is warranted. If

narrower or less stringent State or local requirements were preempted,

as comments suggest, those States and localities would be left with no

State or local requirements at all. Therefore, contrary to the concern

[[Page 63274]]

expressed by comments, the public health protection in those

jurisdictions would be diminished, not enhanced.

A few comments urged that, rather than preempt more stringent State

or local requirements, FDA should leave them intact. In that case,

exemptions from preemption would not be required. Section 521 of the

act clearly states that State or local restrictions that are

``different from'' or ``in addition to'' FDA restrictions are

preempted. However, FDA will continue to consider applications for

exemptions from preemption for more stringent State or local

requirements that provide greater public health protection without

imposing significant burdens on interstate commerce.

One comment urged FDA to refrain from issuing general

determinations concerning whether a certain type of State or local

requirement is preempted. Specifically, the comment disagreed with

FDA's using as an example of a narrower restriction in the proposed

rule State or local laws that hold retailers to a standard lower than

strict liability for selling cigarettes or smokeless tobacco to persons

under 18. This comment argued that, while as a general rule Medtronic

holds that narrower State or local laws are not preempted under section

521(a) of the act, FDA should accept evidence that a specific State or

local requirement, although narrower, is nonetheless ``different'' from

the FDA requirement and preempted under the act.

FDA believes that it is important to provide States and localities

with examples of how to apply the agency's interpretation of the scope

of preemption under section 521 of the act, especially because the

agency refined its interpretation of Medtronic. By providing an example

FDA intends to assist States and localities in determining whether they

need to apply for an exemption. FDA agrees with the comment that the

agency must determine whether a particular requirement is preempted on

a case-by-case basis considering, among other factors, the statutory,

regulatory or other language, any judicial or administrative

interpretations, and any information regarding implementation or

enforcement of the requirement. Therefore, FDA remains open to

receiving specific information regarding a particular State or local

requirement and would consider the information in determining whether

the requirement were preempted under section 521(a) of the act.

Several comments suggested that FDA preempt certain types of

requirements, including State laws that hold retailers to a standard

lower than strict liability for illegally selling tobacco products to

minors, and State laws that prohibit using minors to aid in the

inspection of tobacco retailers\3\. Comments argued that these types of

requirements should be preempted because they frustrate the purpose of

the tobacco rule by making it difficult for FDA to enforce the Federal

requirements.

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\3\ To ensure that retailers are complying with the tobacco rule

and refusing to sell cigarettes or smokeless tobacco to persons

under age 18, FDA will conduct compliance checks, wherein an

adolescent, accompanied by a State commissioned officer, will

attempt to purchase cigarettes or smokeless tobacco.

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First, FDA continues to believe that under Medtronic State or local

requirements holding retailers liable for knowingly or negligently

selling cigarettes or smokeless tobacco to persons under age 18 are not

preempted. As explained in the proposal (62 FR 7390 at 7391), State or

local statutes that require proving a retailer's negligence or

knowledge in an underage sale are similar to counterpart Federal

requirements holding retailers strictly liable for illegally selling

cigarettes or smokeless tobacco to minors, but they are narrower in

scope than the tobacco rule's prohibition of sales to persons under age

18 and therefore are not preempted. Second, because FDA does not have

before it a positive enactment to consider, the agency declines to

issue an opinion on the preemptive effect of section 521 of the act on

the types of requirements that prohibit the use of minors in

inspections. Without a specific State or local enactment before the

agency, including any legislative, administrative, judicial or

enforcement history, the agency cannot determine the effect of either

section 521(a) of the act or more general principles of Federal

preemption.

Therefore, in response to applications received, FDA is granting

exemptions from Federal preemption for certain State requirements in

Alabama, Alaska, and Utah relating to cigarettes or smokeless tobacco.

List of Subjects in 21 CFR Part 808

Intergovernmental relations, Medical devices.

Therefore, under the Federal Food, Drug, and Cosmetic Act and under

authority delegated to the Commissioner of Food and Drugs, 21 CFR part

808 is amended as follows:

PART 808--EXEMPTIONS FROM FEDERAL PREEMPTION OF STATE AND LOCAL

MEDICAL DEVICE REQUIREMENTS

1. The authority citation for 21 CFR part 808 continues to read as

follows:

Authority: 21 U.S.C. 360j, 360k, 371.

2. Section 808.51 is added to subpart C to read as follows:

Sec. 808.51 Alabama.

To the extent that the age restriction on the sale, barter, and

exchange of cigarettes and smokeless tobacco found in Alabama Code,

section 13A-12-3, is preempted under section 521(a) of the act, the

Food and Drug Administration has exempted it from preemption under

section 521(b) of the act.

3. Section 808.52 is added to subpart C to read as follows:

Sec. 808.52 Alaska.

To the extent that the age restriction on the sale and exchange of

cigarettes and smokeless tobacco found in Alaska Statutes, sections

11.76.100(a), is preempted under section 521(a) of the act, the Food

and Drug Administration has exempted it from preemption under section

521(b) of the act.

4. Section 808.94 is added to subpart C to read as follows:

Sec. 808.94 Utah.

To the extent that the age restriction on sales of cigarettes and

smokeless tobacco found in the Utah Code Annotated, section 76-10-104,

is preempted under section 521(a) of the act, the Food and Drug

Administration has exempted it from preemption under section 521(b) of

the act.

Dated: November 18, 1997.

William B. Schultz,

Deputy Commissioner for Policy.

[FR Doc. 97-31213 Filed 11-26-97; 8:45 am]

BILLING CODE 4160-01-F