[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
