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

<RULE> DEPARTMENT OF HEALTH AND HUMAN SERVICES <SUBAGY>Food and Drug Administration</SUBAGY> <CFR>21 CFR Part 1140</CFR> <DEPDOC>[Docket No. FDA-2020-N-1395]</DEPDOC> <RIN>RIN 0910-AI51</RIN> <SUBJECT>Prohibition of Sale of Tobacco Products to Persons Younger Than 21 Years of Age</SUBJECT> <HD SOURCE="HED">AGENCY:</HD> Food and Drug Administration, HHS. <HD SOURCE="HED">ACTION:</HD> Final rule. <SUM> <HD SOURCE="HED">SUMMARY:</HD> 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. </SUM> <EFFDATE> <HD SOURCE="HED">DATES:</HD> This rule is effective September 30, 2024. </EFFDATE> <HD SOURCE="HED">ADDRESSES:</HD> For access to the docket to read background documents, go to <E T="03">https://www.regulations.gov</E> 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. <FURINF> <HD SOURCE="HED">FOR FURTHER INFORMATION CONTACT:</HD> 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, <E T="03">AskCTP@fda.hhs.gov.</E> </FURINF> <SUPLINF> <HD SOURCE="HED">SUPPLEMENTARY INFORMATION:</HD> <HD SOURCE="HD1">Table of Contents</HD> <EXTRACT> <FP SOURCE="FP-2">I. Purpose of the Regulatory Action</FP> <FP SOURCE="FP-2">II. Background</FP> <FP SOURCE="FP1-2">A. The Tobacco Control Act</FP> <FP SOURCE="FP1-2">B. The Deeming Rule and Covered Tobacco Products</FP> <FP SOURCE="FP1-2">C. Further Consolidated Appropriations Act, 2020</FP> <FP SOURCE="FP-2">III. Legal Authority</FP> <FP SOURCE="FP-2">IV. Description of the Final Rule</FP> <FP SOURCE="FP-2">V. Economic Analysis of Impacts</FP> <FP SOURCE="FP1-2">A. Introduction</FP> <FP SOURCE="FP1-2">B. Benefits, Costs, and Transfers</FP> <FP SOURCE="FP-2">VI. Paperwork Reduction Act of 1995</FP> <FP SOURCE="FP-2">VII. Federalism</FP> <FP SOURCE="FP-2">VIII. Consultation and Coordination With Indian Tribal Governments</FP> </EXTRACT> <HD SOURCE="HD1">I. Purpose of the Regulatory Action</HD> The Appropriations Act, enacted on December 20, 2019, established and made immediately effective  <SU>1</SU> <FTREF/> 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). <FTNT> <SU>1</SU>  Because the Appropriations Act did not provide a later effective date, the new provision became effective immediately. </FTNT> 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, <SU>2</SU> <FTREF/> 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 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. <FTNT> <SU>2</SU>  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. </FTNT> <HD SOURCE="HD1">II. Background</HD> 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. <HD SOURCE="HD2">A. The Tobacco Control Act</HD> 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 (§ 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 (§ 1140.14(b)(1)), but did not require such verification for any person over the age of 26 (§ 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 (§ 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 § 1140.3 as follows: • <E T="03">Cigarette</E> 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. • <E T="03">Cigarette tobacco</E> 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. • <E T="03">Smokeless tobacco</E> 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. <HD SOURCE="HD2">B. The Deeming Rule and Covered Tobacco Products</HD> 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 § 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). <SU>3</SU> <FTREF/> Specifically, the Deeming Rule amended § 1140.14 to add, among others, provisions prohibiting retailers from selling covered tobacco p ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━ Preview showing 10k of 23k characters. Full document text is stored and available for version comparison. ━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━━