[Federal Register Volume 89, Number 169 (Friday, August 30, 2024)]
[Rules and Regulations]
[Pages 70483-70486]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2024-19481]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 1140

[Docket No. FDA-2020-N-1395]
RIN 0910-AI51


Prohibition of Sale of Tobacco Products to Persons Younger Than 
21 Years of Age

AGENCY: Food and Drug Administration, HHS.

ACTION: Final rule.

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SUMMARY: The Food and Drug Administration is issuing a final rule to 
make conforming changes as required by the Further Consolidated 
Appropriations Act, 2020 (Appropriations Act), which established a new 
Federal minimum age of sale for tobacco products. These conforming 
changes include increasing the minimum age of sale for cigarettes, 
smokeless tobacco, and covered tobacco products from 18 to 21 years of 
age; increasing the minimum age for age verification by means of 
photographic identification for cigarettes, smokeless tobacco, and 
covered tobacco products from under the age of 27 to under the age of 
30; increasing the minimum age of individuals who may be present or 
permitted to enter facilities that maintain vending machines to sell 
cigarettes, smokeless tobacco, or covered tobacco products from 18 to 
21 years of age; and increasing the minimum age of individuals who may 
be present or permitted to enter facilities that maintain self-service 
displays that sell cigarettes or smokeless tobacco from 18 to 21 years 
of age.

DATES: This rule is effective September 30, 2024.

ADDRESSES: For access to the docket to read background documents, go to 
https://www.regulations.gov and insert the docket number found in 
brackets in the heading of this final rule into the ``Search'' box and 
follow the prompts, and/or go to the Dockets Management Staff, 5630 
Fishers Lane, Rm. 1061, Rockville, MD 20852, 240-402-7500.

FOR FURTHER INFORMATION CONTACT: Beth Buckler, Center for Tobacco 
Products, Food and Drug Administration, Document Control Center, 10903 
New Hampshire Ave., Bldg. 71, Rm. G335, Silver Spring, MD 20993-0002, 
877-287-1373, [email protected].

SUPPLEMENTARY INFORMATION:

Table of Contents

I. Purpose of the Regulatory Action
II. Background
    A. The Tobacco Control Act
    B. The Deeming Rule and Covered Tobacco Products
    C. Further Consolidated Appropriations Act, 2020
III. Legal Authority
IV. Description of the Final Rule
V. Economic Analysis of Impacts
    A. Introduction
    B. Benefits, Costs, and Transfers
VI. Paperwork Reduction Act of 1995
VII. Federalism
VIII. Consultation and Coordination With Indian Tribal Governments

I. Purpose of the Regulatory Action

    The Appropriations Act, enacted on December 20, 2019, established 
and made immediately effective \1\ a new Federal minimum age for the 
sale of tobacco products (Pub. L. 116-94, div. N, tit. I, subt. F, sec. 
603, 133 Stat. 2534, 3123-24). Specifically, the Appropriations Act 
amended section 906(d) of the Federal Food, Drug, and Cosmetic Act (21 
U.S.C. 387f(d)) (FD&C Act) to make it unlawful for any retailer to sell 
a tobacco product to any person younger than 21 years of age. The 
Appropriations Act also directed the Food and Drug Administration (FDA, 
the Agency, or we) to issue a final rule to amend its regulations to 
update the minimum age-related requirements in subpart B of part 1140 
(21 CFR part 1140).
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    \1\ Because the Appropriations Act did not provide a later 
effective date, the new provision became effective immediately.
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    As required by the Appropriations Act, FDA is issuing this final 
rule to make conforming changes to its regulations to: (1) reflect the 
increased minimum age of sale for cigarettes,\2\ smokeless tobacco, and 
covered tobacco products from 18 to 21 years of age; (2) increase the 
minimum age for verification by means of photographic identification 
for cigarettes, smokeless tobacco, and covered tobacco products from 
under the age of 27 to under the age of 30; (3) increase the minimum 
age of persons who may be present or permitted to enter at any time for 
facilities that maintain vending machines to sell cigarettes, smokeless 
tobacco, or covered tobacco products from 18 to 21 years of age; and 
(4) increase the minimum age of persons who may be present or permitted 
to enter at any time for facilities that maintain self-service displays 
to sell cigarettes or smokeless tobacco from 18 to 21 years of age. 
This final rule ensures FDA's regulations align with

[[Page 70484]]

current Federal law as it pertains to age restrictions and tobacco 
products, reducing youth access to such products and providing clarity 
to consumers, retailers, and manufacturers.
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    \2\ As discussed in section II.A of this document, unless 
otherwise stated, the restrictions in part 1140 that are applicable 
to cigarettes also apply to cigarette tobacco.
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II. Background

    FDA is amending part 1140 to apply the new Federal minimum age 
requirements for the sale of tobacco products to cigarettes, smokeless 
tobacco, and covered tobacco products.

A. The Tobacco Control Act

    The Family Smoking Prevention and Tobacco Control Act (Tobacco 
Control Act) was enacted on June 22, 2009, amending the FD&C Act and 
providing FDA with the authority to regulate tobacco products (Pub. L. 
111-31, 123 Stat. 1776). In enacting the Tobacco Control Act, Congress 
found, among other things, that the use of tobacco products is a 
pediatric disease, virtually all new users of tobacco products are 
under 18 years of age, and that tobacco company documents indicate that 
young people are an important and often crucial segment of the tobacco 
market (section 2(1), (4), (20), (23), (24) of the Tobacco Control Act) 
(21 U.S.C. 387 note). Accordingly, Congress directed FDA to reissue, 
among others, provisions contained in its 1996 final rule (61 FR 44396, 
August 28, 1996) that restricted youth access to tobacco products 
(section 102 of the Tobacco Control Act) (21 U.S.C. 387a-1).
    Specifically, section 102 of the Tobacco Control Act required FDA 
to publish a final rule regarding cigarettes and smokeless tobacco 
identical in its provisions to FDA's 1996 final rule (61 FR 44396), 
with certain specified exceptions. Consistent with section 102 of the 
Tobacco Control Act, FDA published a final rule adding a new part 1140 
to title 21, that established restrictions on the sale and distribution 
of cigarettes and smokeless tobacco (75 FR 13225, March 19, 2010).
    Among other things, the rule prohibited the sale of cigarettes and 
smokeless tobacco to any person younger than 18 years of age (Sec.  
1140.14(a)); required retailers to verify by means of photographic 
identification that no person purchasing cigarettes or smokeless 
tobacco was younger than 18 years of age (Sec.  1140.14(b)(1)), but did 
not require such verification for any person over the age of 26 (Sec.  
1140.14(b)(2)); and prohibited the sale of cigarettes and smokeless 
tobacco through vending machines and self-service displays, except in 
facilities where individuals younger than 18 years of age were not 
present or permitted at any time (Sec.  1140.16(c)).
    The final rule also set out definitions for ``cigarette,'' 
``cigarette tobacco,'' and ``smokeless tobacco'' that mirrored those 
definitions set out at section 900 of the FD&C Act (21 U.S.C. 387). 
These terms were (and continue to be) defined in Sec.  1140.3 as 
follows:
     Cigarette means a product that is a tobacco product; and 
meets the definition of the term ``cigarette'' in section 3(1) of the 
Federal Cigarette Labeling and Advertising Act; and includes tobacco, 
in any form, that is functional in the product, which, because of its 
appearance, the type of tobacco used in the filler, or its packaging 
and labeling, is likely to be offered to, or purchased by, consumers as 
a cigarette or as roll-your-own tobacco.
     Cigarette tobacco means any product that consists of loose 
tobacco that is intended for use by consumers in a cigarette. Unless 
otherwise stated, the requirements applicable to cigarettes under this 
chapter shall also apply to cigarette tobacco.
     Smokeless tobacco means any tobacco product that consists 
of cut, ground, powdered, or leaf tobacco and that is intended to be 
placed in the oral or nasal cavity.
    Products that meet these definitions are generally subject to the 
restrictions in part 1140.

B. The Deeming Rule and Covered Tobacco Products

    On May 10, 2016, FDA issued a final rule deeming all products 
meeting the statutory definition of ``tobacco product,'' excluding 
accessories of newly deemed tobacco products, to be subject to chapter 
IX of the FD&C Act and its implementing regulations (Deeming Rule) (81 
FR 28974; codified at 21 CFR part 1100). Under section 906(d) of the 
FD&C Act (21 U.S.C. 387f(d)), the Deeming Rule also established age and 
identification restrictions for ``covered tobacco products,'' defined 
as any tobacco product deemed to be subject to the FD&C Act under Sec.  
1100.2 (21 CFR 1100.2), but excluding any component or part that is not 
made or derived from tobacco (81 FR 28974 at 29103, codified at 21 CFR 
1140.3).\3\ Specifically, the Deeming Rule amended Sec.  1140.14 to 
add, among others, provisions prohibiting retailers from selling 
covered tobacco products to any person younger than 18 years of age, 
requiring age verification by means of photographic identification for 
any person purchasing covered tobacco products under the age of 27, and 
prohibiting vending machine sales of covered tobacco products in 
facilities where persons younger than 18 years of age were present or 
permitted to enter at any time.
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    \3\ The following is a nonexhaustive list of covered tobacco 
products subject to the minimum age and identification restrictions 
described in the Deeming Rule and this final rule: cigars, liquid 
nicotine, e-liquids and e-cigarettes containing nicotine, hookah/
waterpipe tobacco, and pipe tobacco. In contrast, the following is a 
nonexhaustive list of components, parts, and accessories that do not 
meet the definition of a covered tobacco product and therefore are 
not subject to such restrictions: atomizers, batteries, waterpipe 
hose cooling attachments, flavored waterpipe charcoals, waterpipe 
tongs, lanyards, matches, and lighters. For more information, please 
visit the FDA website at https://www.fda.gov/tobacco-products/rules-regulations-and-guidance/fdas-deeming-regulations-e-cigarettes-cigars-and-all-other-tobacco-products.
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C. Further Consolidated Appropriations Act, 2020

    Section 603(a) of the Appropriations Act amended chapter IX of the 
FD&C Act and established a new Federal minimum age of 21 years for the 
sale of tobacco products. Specifically, section 603(a) of the 
Appropriations Act added a new provision, that became effective 
immediately, to section 906(d) of the FD&C Act to make it unlawful for 
any retailer to sell a tobacco product to any person younger than 21 
years of age.\4\
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    \4\ Separately, the Consolidated Appropriations Act, 2022 (Pub. 
L. 117-103, 136 Stat. 49) was enacted on March 15, 2022. Among other 
things, the Consolidated Appropriations Act amended the definition 
of ``tobacco product'' in section 201(rr) of the FD&C Act (21 U.S.C. 
321(rr)) to include products that contain nicotine from any source 
(Pub. L. 117-103, div. P, tit. I, subt. B, sec. 111(a), 136 Stat. at 
789). This amendment took effect on April 14, 2022 (id., sec. 
111(c), 136 Stat. at 789). As a result, it is unlawful for any 
retailer to sell a tobacco product containing nicotine from any 
source, including a non-tobacco nicotine product, to any person 
younger than 21 years of age.
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    While section 603(a) of the Appropriations Act refers to tobacco 
products in general, section 603(b) does not. As a result, this rule 
does not expand the scope of the products subject to the age-related 
restrictions, and instead simply increases the age thresholds for those 
restrictions. Section 603(b) of the Appropriations Act directed FDA to 
issue ``a final rule to update the regulations issued under chapter IX 
of the [FD&C] Act (21 U.S.C. 387 et seq.) as appropriate'' to (and only 
to) ``carry out the amendments made by subsection (a).'' The provision 
specified that such updates included updating all references to persons 
younger than 18 years of age in part 1140, subpart B and updating the 
relevant age verification requirements in part 1140 to require age 
verification for individuals under the

[[Page 70485]]

age of 30. Thus, the regulations Congress directed FDA to update are 
the minimum age of sale restrictions in part 1140, subpart B and the 
related age verification restrictions in part 1140, all of which solely 
apply to cigarettes, smokeless tobacco, and covered tobacco products. 
FDA understands section 603(b) to direct FDA only to increase these age 
restrictions and not simultaneously to extend part 1140's age 
restrictions to apply to additional tobacco products. Section 603(b) 
identified two specific conforming changes; both called upon FDA to 
modify particular age restrictions within part 1140--age restrictions 
that, as noted, apply only to cigarettes, smokeless tobacco, and 
covered tobacco products. In contrast to section 603(a) of the 
Appropriations Act, section 603(b) did not use the term ``tobacco 
product,'' and neither of the age-related conforming changes identified 
in section 603(b) suggested that Congress expected FDA to apply the 
identified restrictions to all tobacco products. The legislative 
history of the Appropriations Act does not address section 603, and 
thus does not support a different conclusion. As such, this rule makes 
corresponding amendments to the relevant age restrictions in part 1140 
but does not expand the range of products subject to such restrictions.

III. Legal Authority

    Section 603 of the Appropriations Act amends section 906(d) of the 
FD&C Act to make it unlawful for any retailer to sell a tobacco product 
to any person younger than 21 years of age. Section 603 directs the 
Secretary to issue a final rule to update the regulations issued under 
chapter IX of the FD&C Act, including updating all references to 
persons younger than 18 years of age in part 1140, subpart B and 
updating relevant age verification requirements under part 1140 to 
require age verification for individuals under the age of 30. Under 
section 603(b)(1)(B), this final rule is deemed to be in compliance 
with all applicable provisions of chapter 5 of title 5, U.S. Code and 
all other provisions of law relating to rulemaking procedures. A 
proposed rule under 5 U.S.C. 553(b) is therefore neither required nor 
necessary.

IV. Description of the Final Rule

    Consistent with the requirements of section 603 of the 
Appropriations Act, this rule updates part 1140 to: (1) increase the 
minimum age of sale for cigarettes, smokeless tobacco, and covered 
tobacco products from 18 to 21 years of age; (2) increase the minimum 
age for verification by means of photographic identification for 
cigarettes, smokeless tobacco, and covered tobacco products from under 
the age of 27 to under the age of 30; (3) increase the minimum age of 
persons who may be present or permitted to enter at any time for 
facilities that maintain vending machines to sell cigarettes, smokeless 
tobacco, or covered tobacco products from 18 to 21 years of age; and 
(4) increase the minimum age of persons who may be present or permitted 
to enter at any time for facilities that maintain self-service displays 
to sell cigarettes or smokeless tobacco from 18 to 21 years of age.
    Specifically, in this final rule, FDA is revising the regulations 
as follows:
     In the heading to subpart B, by replacing the number 
``18'' with the number ``21'';
     In Sec.  1140.14(a)(1), (a)(2)(i), (b)(1), (b)(2)(i), and 
(b)(3), by replacing the number ``18'' with the number ``21'';
     In Sec.  1140.14(a)(2)(ii) and (b)(2)(ii), by replacing 
the number ``26'' with the number ``29''; and
     In Sec.  1140.16(c)(2)(ii), by replacing the number ``18'' 
with the number ``21''.

V. Economic Analysis of Impacts

A. Introduction

    We have examined the impacts of the final rule under Executive 
Order (E.O.) 12866, E.O. 13563, E.O. 14094, which direct us to assess 
all benefits, costs, and transfers 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). Rules are ``significant'' under E.O. 12866 section 3(f)(1) 
(as amended by E.O. 14094) if they ``have an annual effect on the 
economy of $200 million or more (adjusted every 3 years by the 
Administrator of [the Office of Information and Regulatory Affairs 
(OIRA)] for changes in gross domestic product); or adversely affect in 
a material way the economy, a sector of the economy, productivity, 
competition, jobs, the environment, public health or safety, or State, 
local, territorial, or tribal governments or communities.'' OIRA has 
determined that this final rule is a significant regulatory action 
under E.O. 12866.
    As directed by the Further Consolidated Appropriations Act, 2020, 
this final rule issued under section 603(b)(1)(B) is ``deemed to be in 
compliance with all applicable provisions of chapter 5 of title 5, 
United States Code and all other provisions of law relating to 
rulemaking procedures.'' This exempts this rulemaking from such 
provisions of law as the Unfunded Mandates Reform Act of 1995 (2 U.S.C. 
1501 et seq., Pub. L. 104-4), the Congressional Review Act/Small 
Business Regulatory Enforcement Fairness Act (5 U.S.C. 801, Pub. L. 
104-121), and Regulatory Flexibility Act (5 U.S.C. 601-612).

B. Benefits, Costs, and Transfers

    In cases where the relevant statutory provisions are entirely self-
implementing even in the absence of the regulation, or the regulatory 
action is one ``over which an agency clearly has essentially no 
regulatory discretion'', OMB's Circular A-4 allows for the use of a 
``with-statute'' baseline. A with-statute baseline means that an Agency 
is only tasked to assess the impacts of the rule that are up to its 
discretion. Section 603(b) of the Appropriation Act charges FDA with 
publishing ``in the Federal Register a final rule to update the 
regulations issued under chapter IX of the Federal Food, Drug, and 
Cosmetic Act (21 U.S.C. 387 et seq.)'' to make edits to conform the 
regulations to the statutory changes. As FDA ``clearly has essentially 
no regulatory discretion'' over any of the provisions of this rule, we 
do not assess costs, benefits, or transfers for this final rule.

VI. Paperwork Reduction Act of 1995

    This final rule contains no collection of information. Therefore, 
clearance by the Office of Management and Budget under the Paperwork 
Reduction Act of 1995 is not required.

VII. Federalism

    We have analyzed this final rule in accordance with the principles 
set forth in E.O. 13132. We have determined that the rule does not 
contain policies that have substantial direct effects on the States, on 
the relationship between the National Government and the States, or on 
the distribution of power and responsibilities among the various levels 
of government. Accordingly, we conclude that the rule does not contain 
policies that have federalism implications as defined in the E.O. and, 
consequently, a federalism summary impact statement is not required.

VIII. Consultation and Coordination With Indian Tribal Governments

    We have analyzed this final rule in accordance with the principles 
set forth in E.O. 13175. FDA received a request for Tribal 
consultation, but the Agency did not consider consultation on this 
regulation to be practicable. As previously discussed, the

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Appropriations Act established and made immediately effective a new 
Federal minimum age of 21 for the sale of tobacco products. The 
Appropriations Act also directed FDA to issue this final rule to make 
conforming changes to its regulations. Accordingly, a Tribal summary 
impact statement is not required.

List of Subjects in 21 CFR Part 1140

    Advertising, Labeling, Smoking, Tobacco.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
1140 is amended as follows:

PART 1140--CIGARETTES, SMOKELESS TOBACCO, AND COVERED TOBACCO 
PRODUCTS

0
1. The authority citation for part 1140 is revised to read as follows:

    Authority:  21 U.S.C. 301 et seq.; 21 U.S.C. 387a-1; Pub. L. 
116-94, div. N, tit. I, subt. F, sec. 603, 133 Stat. 2534, 3123; 
Pub. L. 117-103, div. P, tit. I, subt. B, sec. 111(a), 136 Stat. 49, 
789.

0
2. Revise the heading for subpart B to read as follows:

Subpart B--Prohibition of Sale and Distribution to Persons Younger 
Than 21 Years of Age


Sec.  1140.14  [Amended]

0
3. Amend Sec.  1140.14 by:
0
a. Removing the number ``18'', wherever it appears, and adding in its 
place the number ``21''; and
0
b. Removing the number ``26'', wherever it appears, and adding in its 
place the number ``29''.


Sec.  1140.16  [Amended]

0
4. Amend Sec.  1140.16, in paragraph (c)(2)(ii), by removing the number 
``18'' and adding in its place the number ``21''.

    Dated: August 15, 2024.
Robert M. Califf,
Commissioner of Food and Drugs.
[FR Doc. 2024-19481 Filed 8-29-24; 8:45 am]
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