[Federal Register Volume 62, Number 33 (Wednesday, February 19, 1997)]
[Proposed Rules]
[Pages 7390-7395]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 97-4045]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES
21 CFR Part 808

[Docket No. 96N-0249]
RIN 0910-AB03


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: Proposed rule.

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SUMMARY: The Federal Food, Drug, and Cosmetic Act (the act) preempts 
State and local device requirements that are different from, or in 
addition to, Federal requirements under the act. The act also provides 
that the Food and Drug Administration (FDA) may, by regulation, exempt 
State and local device requirements from preemption. FDA is responding 
to applications for exemption submitted by the States of Alabama, 
Alaska, Utah, and Washington. FDA is proposing to grant exemptions from 
Federal preemption for certain cigarette and smokeless tobacco 
requirements in the States of Alabama, Alaska, and Utah. The 
requirements in the State of Washington are not preempted, and 
therefore no exemption needs to be granted. Elsewhere in this issue of 
the Federal Register, FDA is announcing an opportunity for interested 
persons to request a public hearing on the proposed regulation.

DATES: Written comments by March 21, 1997. FDA proposes that any final 
rule that may be issued based on this proposal become effective 30 days 
after the date of its publication in the Federal Register.

ADDRESSES: Written comments to the Dockets Management Branch (HFA-305), 
Food and Drug Administration, 12420 Parklawn Dr., rm. 1-23, Rockville, 
MD 20857.

FOR FURTHER INFORMATION CONTACT: Anne M. Kirchner, Office of Policy 
(HF-23), Food and Drug Administration,

[[Page 7391]]

5600 Fishers Lane, Rockville, MD 20857, 301-827-5321.

SUPPLEMENTARY INFORMATION: 

I. Background

    In the Federal Register of August 28, 1996 (61 FR 44396), FDA 
published a final rule (the tobacco rule) restricting the sale and 
distribution of nicotine-containing cigarettes and smokeless tobacco in 
order to protect children and adolescents. The tobacco rule included 
provisions prohibiting retailers from selling nicotine-containing 
cigarettes or smokeless tobacco to any person younger than 18 years of 
age (see Sec. 897.14(a) (21 CFR 897.14(a))) and requiring retailers to 
verify, by means of photographic identification containing the bearer's 
date of birth, that no person purchasing cigarettes or smokeless 
tobacco is younger than 18 years of age (see Sec. 897.14(b)). The age 
verification requirement applies except where the purchaser is over age 
26.
    Section 521(a) of the act (21 U.S.C. 360k(a)) provides that,
    [a]fter May 28, 1976, no State or political subdivision of a 
State may establish or continue in effect, with respect to a device 
intended for human use, any requirement having the force and effect 
of law (whether established by statute, ordinance, regulation, or 
court decision), which is different from, or in addition to, any 
requirement applicable to such device under any provision of the act 
and which relates to the device's safety or effectiveness, or to any 
other matter included in a requirement applicable under the act 
(Sec. 808.1(b)(21 CFR 808.1(b))).
Because FDA is regulating cigarettes and smokeless tobacco as nicotine-
delivery devices under the act, any State or local cigarette or 
smokeless tobacco requirement that is different from, or in addition 
to, the specific requirements for cigarettes and smokeless tobacco 
established under the tobacco rule is preempted under section 521(a) of 
the act.
    In implementing section 521(a) of the act, FDA has historically 
interpreted that provision narrowly and 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. Consistent 
with this narrow scope of preemption under section 521(a) of the act, a 
State or local requirement that is narrower in coverage than the 
Federal requirement is not preempted to the extent that it is similar 
to the Federal requirement.
    Examples of such similar, yet narrower, coverage by State or local 
requirements include additional statutory elements or defenses in 
conjunction with minimum age restrictions on sales of cigarettes and 
smokeless tobacco. For instance, numerous States have statutes that 
prohibit retailers from ``negligently'' or ``knowingly'' selling 
cigarettes or smokeless tobacco to persons under the age of 18. Other 
States have fashioned their age prohibition statutes such that 
retailers can assert as a defense to any penalties that they properly 
checked and relied upon an identification presented by an underage 
purchaser.
    Such statutes are narrower in scope than the strict liability 
provision of the tobacco rule because they require proving a retailer's 
negligence or knowledge in an underage sale. However, because these 
statutes are similar to the tobacco rule's prohibition of sales to 
persons under the age of 18, they are not preempted merely because of 
their narrower coverage. A State or local government clearly could 
choose to have no statute whatsoever in effect regarding age 
restrictions. FDA believes it logically follows that a State or local 
government may enact a statutory level of enforcement that falls 
somewhere between the level of no enforcement and the level implemented 
in the tobacco rule.
    The narrow preemption in these situations is based on the Supreme 
Court's recent decision in Medtronic, Inc. v. Lohr, 116 S. Ct. 2240 
(1996). The Court held that common law tort claims that are similar to, 
but narrower than, FDA requirements are not preempted under section 521 
of the act. (See Lohr, 116 S. Ct. at 2255.) In so holding, the Court 
reasoned as follows:
    Nothing in [section 521] denies [a State] the right to provide a 
traditional damages remedy for violations of common-law duties when 
those duties parallel federal requirements. Even if it may be 
necessary as a matter of [State] law to prove that those violations 
were the result of negligent conduct, or that they created an 
unreasonable hazard for users of the product, such additional 
elements of the state-law cause of action would make the state 
requirements narrower, not broader, than the federal requirement. 
While such a narrower requirement might be ``different from'' the 
federal rules in a literal sense, such a difference would surely 
provide a strange reason for finding pre-emption of a state rule 
insofar as it duplicates the federal rule.
Id.
    Section 521(b) of the act provides that FDA may, upon application 
by a State or political subdivision, and by regulation issued after 
notice and an opportunity for an oral hearing, exempt a State or local 
device requirement from preemption under such conditions as FDA may 
prescribe if the requirement is: (1) More stringent than an FDA 
requirement applicable to the device, or (2) required by compelling 
local conditions, and compliance with it would not cause the device to 
be in violation of any applicable requirement under the act.
    In the Federal Register of November 7, 1996 (61 FR 57685), FDA 
published a notice (the exemption notice) inviting State and local 
governments to file applications for exemption from preemption for 
cigarette and smokeless tobacco requirements. In order to facilitate 
and expedite review of submitted applications, FDA is considering the 
applications in two separate groups, which are based on the effective 
dates for different requirements under the tobacco rule. This proposed 
rule covers those applications, designated in the exemption notice as 
Group 1, which are for State and local requirements that are different 
from, or in addition to, FDA requirements under Sec. 897.14(a) and (b) 
of the tobacco rule. (See 61 FR 57685 at 57686.) Applications for other 
State and local requirements pertaining to cigarettes and smokeless 
tobacco will be considered in another proposed rule which will be 
published in the future.

II. Descriptions of the Requests for Exemption from Preemption

A. State of Alabama

    On October 28, 1996, the State of Alabama applied for exemption 
from preemption for section 13A-12-3 of the Alabama Code. The provision 
reads as follows:
    Sec. 13A-12-3. Selling cigarettes to minors.
    Any person who sells, barters, exchanges or gives to any minor 
any cigarettes, cigarette tobacco or cigarette paper, or any 
substitute for either of them shall, on conviction, be fined not 
less that $10.00 nor more than $50.00 and may also be imprisoned in 
the county jail or sentenced to hard labor for the county for not 
more than 30 days.
    Section 26-1-1 of the Alabama Code establishes age 19 as the age of 
majority.\1\ Consequently, section 13A-

[[Page 7392]]

 12-3 of Alabama Code, when interpreted in light of section 26-1-1 of 
Alabama Code, prohibits, in part, any person from selling, bartering, 
exchanging, or giving cigarettes, cigarette tobacco or cigarette paper, 
or any substitute to persons under 19 years of age in Alabama.
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    \1\ The text of section 26-1-1 of the Alabama Code is as 
follows:
    Sec. 26-1-1. Age of majority designated as 19 years.
    (a) Any person in this state, at the arrival at the age of 19 
years, shall be relieved of his disabilities of minority and 
thereafter shall have the same legal rights and abilities as persons 
over 21 years of age. No law of this state shall discriminate for or 
against any person between and including the ages of 19 and 21 years 
solely on the basis of age.
    (b) This section shall also apply to any person who arrived at 
the age of 19 and 20 years before July 22, 1975, but shall not 
abrogate any defense or abridge any remedy available to him prior to 
such date.
    (c) All laws or parts of laws which read ``under the age of 21 
years'' hereafter shall read ``under the age of 19 years.'' Wherever 
the words ``under the age of 21 years'' appear in any law limiting 
the legal rights and abilities of persons under such age, such words 
shall be construed to mean under the age of 19 years.
    (d) Notwithstanding the provisions of subsection (c) of this 
section, nothing in this section shall be deemed to repeal any 
provision of Chapter 19 of Title 15 of this Code.
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    The prohibition under section 13A-12-3 of the Alabama Code against 
selling, bartering, or exchanging tobacco products to anyone under 19 
years of age is different from the age restriction contained in the 
tobacco rule at Sec. 897.14(a), which prohibits sales of cigarettes and 
smokeless tobacco to anyone under age 18.\2\ FDA believes, however, 
that Alabama's higher minimum age for the sale, barter, and exchange of 
cigarette and smokeless tobacco will provide increased public health 
benefits and will not impose a significant burden on retailers. 
Therefore, to the extent that the age restriction on the sale, barter, 
and exchange of tobacco products found in section 13A-12-3 of the 
Alabama Code is preempted, FDA is proposing to grant an exemption from 
preemption.
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    \2\ Under Sec. 897.14(a), ``[n]o retailer may sell cigarettes or 
smokeless tobacco to any person younger than 18 years of age.'' This 
prohibition on ``selling'' cigarettes or smokeless tobacco extends 
to transactions involving ``bartering'' or ``exchanging'' these 
products for other items that ultimately have some value.
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    In addition, section 13A-12-3 of the Alabama Code prohibits giving 
cigarettes, cigarette tobacco or cigarette paper, or any substitute to 
anyone under the age of 19. Because the restriction on distribution of 
tobacco products found in section 13A-12-3 of the Alabama Code does not 
prohibit the distribution of free samples of cigarettes and smokeless 
tobacco to persons over the age of 19, section 13A-12-3 of the Alabama 
Code is narrower in scope than the complete prohibition against 
distribution of free samples of cigarettes and smokeless tobacco 
established in the tobacco rule under Sec. 897.16(d) (21 CFR 
897.16(d)).\3\ Despite its narrower scope of coverage, this portion of 
the statute is not preempted because it is similar to the tobacco 
rule's restrictions on the distribution of free samples of cigarette 
and smokeless tobacco. FDA notes, however, that the narrower scope of 
coverage at the State level in Alabama as established under section 
13A-12-3 of the Alabama Code in no way narrows or limits the scope of 
coverage of Federal requirements contained in the tobacco rule.
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    \3\ Although the focus of this proposed rule is upon requests 
for exemption from preemption with respect to the requirements of 
Sec. 897.14(a) (involving retail sales) and Sec. 897.14(b) 
(involving verification of purchaser's age), section 13A-12-3 of the 
Alabama Code also contains distribution restrictions that are 
analogous to those restrictions found in Sec. 897.16(d) (involving 
free distribution). For reasons of expediency, FDA will address the 
issue of preemption of section 13A-12-3 of the Alabama Code, in that 
section's entirety, in this rulemaking.
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    Finally, to the extent that section 13A-12-3 of the Alabama Code 
applies to products other than cigarettes or smokeless tobacco, the 
statute is not preempted by the tobacco rule because the tobacco rule 
does not establish ``specific counterpart regulations'' or other 
specific requirements with respect to products other than cigarettes or 
smokeless tobacco.

B. State of Alaska

    On November 27, 1996, the State of Alaska applied for an exemption 
from preemption for sections 11.76.100 and 11.76.105 of the Alaska 
Statutes. The request, in part, concerned Alaska's prohibition against 
selling, exchanging, or giving cigarettes, cigars, tobacco, or tobacco-
containing products to persons under age 19, as well as its prohibition 
against the possession of cigarettes, cigars, tobacco, or tobacco-
containing products by persons under age 19. The relevant provisions of 
section 11.76.100 of the Alaska Statutes read as follows:
    Sec. 11.76.100. Selling or giving tobacco to a minor.
    (a) A person commits the offense of selling or giving tobacco to 
a minor if the person is 19 years of age or older and
    (1) negligently sells, exchanges, or gives a cigarette, a cigar, 
tobacco, or a product containing tobacco to a person under 19 years 
of age;
* * * * * \4\
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    \4\ The remaining portions of section 11.76.100 of the Alaska 
Statutes for which Alaska seeks exemption from preemption concern 
vending machine sales. FDA will address the vending machine sales 
portions of section 11.76.100 of the Alaska Statutes in a future 
proposed rulemaking.
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    (f) The provisions of (a) of this section do not apply to a 
person who sells or gives tobacco to a minor if the minor is a 
prisoner at an adult correctional facility.
    The prohibition under section 11.76.100(a) of the Alaska Statutes 
against selling or exchanging tobacco to anyone under 19 years of age 
is different from the age restriction contained in Sec. 897.14(a), 
which prohibits sales of cigarettes and smokeless tobacco to anyone 
under age 18.\5\ FDA believes, however, that Alaska's higher minimum 
age for the sale and exchange of cigarettes and smokeless tobacco will 
provide increased public health benefits and will not impose a 
significant burden on retailers. Therefore, to the extent that the age 
restriction on the sale and exchange of cigarettes and smokeless 
tobacco found in section 11.76.100(a) of the Alaska Statutes is 
preempted, FDA is proposing to grant an exemption from preemption.
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    \5\ Under Sec. 897.14(a), ``[n]o retailer may sell cigarettes or 
smokeless tobacco to any person younger than 18 years of age.'' This 
prohibition on ``selling'' cigarettes or smokeless tobacco extends 
to transactions involving ``exchanging'' these products for other 
items that ultimately have some value.
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    Section 11.76.100(a) of the Alaska Statutes also prohibits giving 
tobacco products to anyone under the age of 19. Because the restriction 
on distribution of tobacco products found in section 11.76.100(a) of 
the Alaska Statutes does not prohibit the distribution of free samples 
of cigarettes and smokeless tobacco to persons over the age of 19, 
section 11.76.100(a) of the Alaska Statutes is narrower in scope than 
the complete prohibition against distribution of free samples of 
cigarettes and smokeless tobacco established under Sec. 897.16(d) of 
the tobacco rule.\6\ Although section 11.76.100(a) of the Alaska 
Statutes has a narrower scope of coverage than the tobacco rule with 
regard to distribution of tobacco products, this portion of the statute 
is not preempted because it is similar to the tobacco rule's 
restrictions on cigarette and smokeless tobacco distribution. FDA 
notes, however, that the narrower scope of coverage at the State level 
in Alaska as established under section 11.76.100(a) of the Alaska 
Statutes does not narrow or limit the scope of coverage of Federal 
requirements contained in the tobacco rule.
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    \6\ Despite the focus of this proposed rule upon State and local 
requirements regarding retail sales of cigarettes and smokeless 
tobacco, and verification of purchaser's age, FDA will also address 
the issue of preemption of the age restrictions on distribution of 
tobacco products found in section 11.76.100(a) of the Alaska 
Statutes.
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    Because section 11.76.100(a) of the Alaska Statutes prohibits the 
``negligent'' selling or giving of tobacco to a minor, that section is 
narrower in scope than the strict liability provisions found in the 
tobacco rule. However, because section 11.76.100(a) of the Alaska 
Statutes is similar to the tobacco rule's restrictions on cigarette and 
smokeless tobacco sales and distribution, the statute is not preempted 
merely because of its narrower coverage. As stated above, the narrower 
coverage of section 11.76.100(a) of the Alaska Statutes does not narrow 
or limit the scope of Federal coverage under the tobacco rule.
    To the extent that section 11.76.100(a) of the Alaska Statutes 
applies to

[[Page 7393]]

products other than cigarettes or smokeless tobacco, the statute is not 
preempted by the tobacco rule because the tobacco rule does not 
establish ``specific counterpart regulations'' or other specific 
requirements with respect to products other than cigarettes or 
smokeless tobacco.
    Section 11.76.100(f) of the Alaska Statutes is not preempted by 
section 521 of the act. Section 11.76.100(f) of the Alaska Statutes 
provides an exception to the State's prohibition of underage sales and 
distribution of tobacco products. Under this exception a person may 
``sell[ ] or give[ ] tobacco to a minor if the minor is a prisoner at 
an adult correctional facility.''
    This exception is narrower in scope of coverage than the Federal 
prohibitions found in Secs. 897.14(a) and 897.16(d). Clearly, the 
Alaskan State legislature could have chosen not to enact any 
prohibitions whatsoever regarding underage sales and distribution of 
tobacco products. The level of prohibition actually enacted, however, 
falls between a no-prohibition level and the level of enforcement at 
the Federal level under the tobacco rule.
    Despite the narrower scope of section 11.76.100(f) of the Alaska 
Statutes, the statute is not preempted because the State's prohibition 
of underage sales and distribution of tobacco products is similar to 
the tobacco rule's restrictions on cigarette and smokeless tobacco 
sales and distribution. However, the narrower coverage of section 
11.76.100(f) of the Alaska Statutes does not narrow or limit the scope 
of Federal coverage under the tobacco rule; thus, for example, the sale 
of cigarettes or smokeless tobacco to any person under the age of 18, 
including such a person who is a prisoner at an adult correctional 
facility, would violate the prohibitions contained in the tobacco rule.
    The State of Alaska has also applied for exemption from preemption 
for section 11.76.105 of the Alaska Statutes. The relevant provisions 
of section 11.76.105 of the Alaska Statutes read as follows:
    Sec. 11.76.105. Possession of tobacco by a minor.
    (a) A person under 19 years of age may not knowingly possess a 
cigarette, a cigar, tobacco, or a product containing tobacco in this 
state. This subsection does not apply to a person who is a prisoner 
at an adult correctional facility.
    Because FDA has not established any specific counterpart regulation 
regarding underage possession of tobacco products, section 11.76.105 of 
the Alaska Statutes is not preempted. Consequently, an exemption from 
preemption for this section is not necessary.

C. State of Utah

    In December 1996, the State of Utah applied for an exemption from 
preemption for section 76-10-104 of the Utah Code Annotated.\7\ The 
provision reads as follows:
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    \7\ The original request sought an exemption from preemption for 
section 76-10-105 of the Utah Code Annotated. That provision states 
that any person under age 19 who buys, accepts, or has in his 
possession any cigar, cigarette, or tobacco in any form is guilty of 
a class C misdemeanor. The provision also discusses the jurisdiction 
of the juvenile court for such offenses and the authority of a 
compliance officer to issue citations. However, the request was 
later amended after FDA noted that this provision in the Utah Code 
Annotated is not preempted (because there is no specific FDA 
counterpart regulation concerning underage persons who buy, accept, 
or possess tobacco products), but that section 76-10-104 might be 
preempted absent an exemption from preemption.
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    76-10-104. Furnishing cigars, cigarettes, or tobacco to minors--
Penalties.
    Any person who sells, gives, or furnishes any cigar, cigarette, 
or tobacco in any form, to any person under 19 years of age, is 
guilty of a class C misdemeanor on the first offense, a class B 
misdemeanor on the second offense, and a class A misdemeanor on 
subsequent offenses.
    The age restriction on ``sell[ing] * * * any cigar, cigarette, or 
tobacco in any form, to any person under 19 years of age'' that is 
found in section 76-10-104 of the Utah Code Annotated differs from the 
requirement in Sec. 897.14(a), which prohibits the sale of cigarettes 
and smokeless tobacco to anyone under age 18. FDA believes, however, 
that Utah's higher minimum age for cigarette and smokeless tobacco 
sales will provide increased public health benefits and will not impose 
a significant burden on retailers. Therefore, to the extent that the 
age restriction on sales of cigarettes and smokeless tobacco found in 
section 76-10-104 of the Utah Code Annotated is preempted, FDA is 
proposing to grant an exemption from preemption.
    Section 76-10-104 of the Utah Code Annotated also prohibits, in 
part, a person from giving or furnishing cigarettes or smokeless 
tobacco to persons under age 19. Because this restriction on 
distribution of tobacco products does not prohibit the distribution of 
free samples of cigarettes and smokeless tobacco to persons over the 
age of 19, section 76-10-104 of the Utah Code Annotated is narrower in 
scope than the complete prohibition against distribution of free 
samples of cigarettes and smokeless tobacco established under 
Sec. 897.16(d).\8\ Although section 76-10-104 of the Utah Code 
Annotated has a narrower scope of coverage than the tobacco rule with 
regard to distribution of tobacco products, this portion of the statute 
is not preempted because it is similar to the tobacco rule's 
restrictions on cigarette and smokeless tobacco distribution. FDA 
notes, however, that the narrower scope of coverage at the State level 
in Utah as established under section 76-10-104 of the Utah Code 
Annotated does not narrow or limit the scope of coverage of Federal 
requirements contained in the tobacco rule.
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    \8\ Despite the focus of this proposed rule upon State and local 
requirements regarding retail sales of cigarettes and smokeless 
tobacco as well as verification of purchaser's age, FDA will address 
the issue of preemption of the age restrictions on distribution of 
tobacco products found in section 76-10-104 of the Utah Code 
Annotated.
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    Finally, to the extent that section 76-10-104 of the Utah Code 
Annotated applies to products other than cigarettes or smokeless 
tobacco, the statute is not preempted by the tobacco rule because the 
tobacco rule does not establish ``specific counterpart regulations'' or 
other specific requirements with respect to products other than 
cigarettes or smokeless tobacco. (See Sec. 808.1(d).)

D. State of Washington

    On December 6, 1996, the State of Washington applied for an 
exemption from preemption for section 26.28.080 of the Revised Code of 
Washington (RCW) (a State law) and section 314-10-050 of the Washington 
Administrative Code (WAC) (a State administrative regulation). RCW 
26.28.080 contains a prohibition against underage sales and 
distribution of certain enumerated tobacco products. WAC 314-10-050 
contains a similar prohibition, but also establishes a requirement that 
purchasers of tobacco products provide proof of age, and lists 
acceptable forms of identification. The relevant provisions read as 
follows:
    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.
    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 a tobacco 
licensee or

[[Page 7394]]

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 a 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.
    RCW 26.28.080 prohibits, in part, a person from giving ``to any 
person under the age of eighteen years any cigar, cigarette, cigarette 
paper or wrapper, or tobacco in any form.'' Similarly, WAC 314-10-
050(1) prohibits, in part, a person from ``giv[ing] or in any way 
provid[ing] tobacco products to any person under 18 years of age.'' 
Because these restrictions on distribution of tobacco products do not 
prohibit the distribution of free samples of cigarettes and smokeless 
tobacco to persons over the age of 18, RCW 26.28.080 and WAC 314-10-
050(1) are narrower in scope than the complete prohibition against 
distribution of free samples of cigarettes and smokeless tobacco 
established under Sec. 897.16(d).\9\ Although RCW 26.28.080 and WAC 
314-10-050(1) have a narrower scope of coverage than the tobacco rule 
with regard to distribution of tobacco products, these portions of the 
statute and the regulation are not preempted because they are similar 
to the tobacco rule's restrictions on cigarette and smokeless tobacco 
distribution. FDA notes, however, that the narrower scope of coverage 
at the State level in Washington as established under RCW 26.28.080 and 
WAC 314-10-050(1) does not narrow or limit the scope of coverage of 
Federal requirements contained in the tobacco rule.
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    \9\ Despite the focus of this proposed rule upon State and local 
requirements regarding retail sales of cigarettes and smokeless 
tobacco as well as verification of purchaser's age, FDA will address 
the issue of preemption of the age restrictions on distribution of 
tobacco products found in RCW 26.28.080 and WAC 314-10-050(1).
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    To the extent that RCW 26.28.080 and WAC 314-10-050(1) apply to 
products other than cigarettes or smokeless tobacco, they are not 
preempted by the tobacco rule because the tobacco rule does not 
establish ``specific counterpart regulations'' or other specific 
requirements with respect to products other than cigarettes or 
smokeless tobacco. (See Sec. 808.1(d).)
    WAC 314-10-050(2) requires any person attempting to purchase 
tobacco products to present identification to establish the purchaser's 
age, and WAC 314-10-050(3) specifies requirements for the types of 
identification that the purchaser must present. FDA has not established 
any specific counterpart regulation that places an affirmative duty 
upon the purchaser to present identification as proof of age. Rather, 
Sec. 897.14(b) requires the retailer to ``verify by means of 
photographic identification * * * that no person purchasing the product 
is younger than 18 years of age.'' Because there is no specific 
counterpart regulation under the act, neither WAC 314-10-050(2) nor WAC 
314-10-050(3) is preempted.
    In conclusion, RCW 26.28.080 and WAC 314-10-050 are not preempted. 
Thus, no exemption is necessary for either provision.

E. The Notice of Opportunity for Hearing

    FDA's regulation in 21 CFR 808.25(c) provides that, when the agency 
issues in the Federal Register a proposed rule either granting or 
denying requests for exemption from preemption, the agency will also 
issue in the Federal Register a notice of opportunity for interested 
persons to request an oral hearing before FDA to present views on the 
applications and the proposed rule. Elsewhere in this issue of the 
Federal Register, FDA is issuing such a notice.

III. Environmental Impact

    The agency has determined under 21 CFR 25.24(e)(8) that this action 
is of a type that does not individually or cumulatively have a 
significant effect on the human environment. Therefore, neither an 
environmental assessment nor an environmental impact statement is 
required.

IV. Analysis of Impacts

    FDA has examined the impacts of the proposed rule under Executive 
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612). 
Executive Order 12866 directs agencies to assess all costs and benefits 
of available regulatory alternatives and, when regulation is necessary, 
to select regulatory approaches that maximize net benefits (including 
potential economic, environmental, public health and safety, and other 
advantages; distributive impacts; and equity). The agency believes that 
this proposed rule is consistent with the regulatory philosophy and 
principles identified in the Executive Order. In addition, this 
document has been reviewed by the Office of Management and Budget as a 
significant regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. Because the proposed rule would exempt certain pre-
existing statutory or regulatory provisions in Alabama, Alaska, and 
Utah from preemption, the Commissioner of Food and Drugs certifies that 
the proposed rule will not have a significant economic impact on a 
substantial number of small entities. Therefore, under the Regulatory 
Flexibility Act, no further analysis is required.
    Interested persons may, on or before March 21, 1997, submit to the 
Dockets Management Branch (address above) written comments regarding 
this proposal. Two copies of any comments are to be submitted, except 
that individuals may submit one copy. Comments are to be identified 
with the docket number found in brackets in the heading of this 
document. Received comments may be seen in the office above between 9 
a.m. and 4 p.m., Monday through Friday.

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, it is 
proposed that 21 CFR part 808 be 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: Secs. 521, 701 of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 360k, 371).

    2. New Sec. 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. New Sec. 808.52 is added to subpart C to read as follows:


[[Page 7395]]




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. New Sec. 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: February 7, 1997.
William B. Schultz,
Deputy Commissioner for Policy.
[FR Doc. 97-4045 Filed 2-13-97; 2:19 pm]
BILLING CODE 4160-01-F