[Federal Register Volume 62, Number 229 (Friday, November 28, 1997)]
[Rules and Regulations]
[Pages 63271-63274]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-31213]


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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