View Rule

Statement of Need: Currently, the Family Smoking Prevention and Tobacco Control Act (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 Food Drug & Cosmetic Act (FD&C Act). This regulation is necessary to afford FDA the authority to regulate these products which include hookah, electronic cigarettes, cigars, pipe tobacco, other novel tobacco products, and future tobacco products.

Summary of the Legal Basis: 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.

Alternatives: In addition to the benefits and costs of the proposed rule, FDA has estimated the benefits and costs of several alternatives to the proposed rule: 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.

Anticipated Costs and Benefits: The proposed rule has two parts: one part deems all tobacco products to be subject to the FD&C Act; the other part proposes additional provisions that would apply to newly-deemed products as well as to other covered tobacco products. The proposed deeming action differs from most public health regulations in that it is an enabling regulation. In other words, in addition to directly subjecting newly-deemed "tobacco products" to the substantive requirements of Chapter IX of the FD&C Act, it enables FDA to issue further public health regulations related to such products. Thus, almost all the potential benefits and most of the costs that flow from the proposed deeming action would be realized in stages over the long term. The proposed rule would generate some immediate quantifiable benefits by dissuading smokers of small and large cigars, thereby improving health and longevity; it would impose costs in the form of registration, submission, labeling, and other requirements.

Risks: 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 additional restrictions that FDA seeks to promulgate for the proposed deemed products would reduce initiation and increase cessation (particularly among youth). 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.