Senior Regulatory Counsel

0910-AG38 201510 The Regulatory Plan and the Unified Agenda of Federal Regulatory and Deregulatory Actions 0910 Food and Drug Administration FDA 0900 Department of Health and Human Services HHS "Tobacco Products" Subject to the Federal Food, Drug, and Cosmetic Act, as Amended by the Family Smoking Prevention and Tobacco Control Act

The Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) provides the Food and Drug Administration (FDA) authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. This rule would deem additional products meeting the statutory definition of "tobacco product" to be subject to the FD&C Act, and would specify additional restrictions.

]]> Economically Significant Previously Published in The Unified Agenda Final Rule Stage Yes Private Sector Not Yet Determined 21 U.S.C. 301 et seq The Federal Food, Drug, and Cosmetic Act Pub. L. 111-31 The Family Smoking Prevention and Tobacco Control Act Yes

Currently, the Tobacco Control Act provides FDA with immediate authority to regulate cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco. The Tobacco Control Act also permits FDA to issue regulations deeming other tobacco products that meet the statutory definition of "tobacco product" to also be subject to the FD&C Act. This regulation is necessary to afford FDA the authority to regulate additional products which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products.

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Section 901 of the FD&C Act, as amended by the Tobacco Control Act, permits FDA to issue regulations deeming other tobacco products to be subject to the FD&C Act. Section 906(d) provides FDA with the authority to propose restrictions on the sale and distribution of tobacco products, including restrictions on the access to, and the advertising and promotion of, tobacco products if FDA determines that such regulation would be appropriate for the protection of the public health.

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In addition to the benefits and costs of both options for the proposed rule, FDA assessed the benefits and costs of several alternatives to the proposed rule: e.g., deeming only, but exempt newly deemed products from certain requirements; exempt certain classes of products from certain requirements; deeming only, with no additional provisions; and changes to the compliance periods.

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The proposed rule consists of two co-proposals, option 1 and option 2. The proposed option 1 deems all products meeting the statutory definition of "tobacco product" except accessories of a proposed deemed tobacco product to be subject to chapter IX of the FD&C Act. Option 1 also proposes additional provisions that would apply to proposed deemed products as well as to certain other tobacco products. Option 2 is the same as option 1 except that it exempts premium cigars. We expect that asserting our authority over these tobacco products will enable us to take further regulatory action in the future as appropriate; those actions will have their own costs and benefits. The proposed rule would generate some direct benefits by providing information to consumers about the risks and characteristics of tobacco products which may result in consumers reducing their use of cigars and other tobacco products. Other potential benefits follow from premarket requirements which could prevent more harmful products from appearing on the market and worsening the health effects of tobacco product use. The proposed rule would impose costs in the form of registration submission labeling and other requirements; other likely costs are not quantifiable based on current data.

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Adolescence is the peak time for tobacco use initiation and experimentation. In recent years, new and emerging tobacco products, sometimes referred to as "novel tobacco products," have been developed and are becoming an increasing concern to public health due, in part, to their appeal to youth and young adults. Non-regulated tobacco products come in many forms, including electronic cigarettes, nicotine gels, and certain dissolvable tobacco products (i.e., those dissolvable products that do not currently meet the definition of smokeless tobacco under 21 U.S.C. 387(18) because they do not contain cut, ground, powdered, or leaf tobacco, and instead contain nicotine extracted from tobacco), and these products are widely available. This deeming rule is necessary to provide FDA with authority to regulate these products (e.g., registration, product and ingredient listing, user fees for certain products, premarket requirements, and adulteration and misbranding provisions). In addition, the additonal restrictions that FDA seeks to promulgate for the proposed deemed products will protect youth by restricting minors' access to these products and will increase consumer understanding of the impact of these products on public health. This rule is consistent with other approaches that the Agency has taken to address the tobacco epidemic and is particularly necessary, given that consumer use may be gravitating to the proposed deemed products.

]]> NPRM 04/25/2014 79 FR 23142 NPRM Comment Period End 07/09/2014 NPRM Comment Period Extended 06/24/2014 79 FR 35711 NPRM Comment Period End 08/08/2014 Final Action 11/00/2015 Yes Businesses Undetermined Undetermined Yes Yes Gerie Voss Senior Regulatory Counsel 0910 Food and Drug Administration FDA 877 287-1373 ctpregulations@fda.hhs.gov HFS-32, Center for Tobacco Products, 10903 New Hampshire Avenue, Document Control Center, Building 71, Room G335, Silver Spring MD 20993