By Patricia K. Ruiz, J.D.
E-cigarettes, cigars, hookah tobacco, pipe tobacco, and all other tobacco products now fall under the authority of the FDA and the federal Food, Drug, and Cosmetic Act (FDC Act) (21 USC §387 et seq.). A new Final rule extends the FDA’s authority to all categories of products that meet the statutory definition of “tobacco product” in the FDC Act, including components and parts of such products, but not accessories. The Final rule prohibits the sale of “covered tobacco products” to individuals under the age of 18 and requires the display of health warnings on cigarette tobacco, roll-your-own tobacco, and covered tobacco product packages, and in advertisements. It will publish in the Federal Register on May 10, 2016.
Authority. Cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco were immediately covered by the FDA’s authority under the FDC Act when the Family Smoking Prevention and Tobacco Control Act (P.L. 111-31) went into effect. For other products, the statute gives the FDA the ability to issue regulations “deeming” them to be subject to its authority and to put in place restrictions on the sale and distribution of the product. Deeming all “tobacco products” (including components and parts but excluding accessories of such products) subject to the FDC Act is intended to result in significant benefits for the public health.
Restrictions on covered products. The FDA established three restrictions for covered tobacco products: (1) requirement for a minimum age of purchase; (2) requirement for health warnings for product packages and advertisements (also applying to cigarette tobacco and roll-your-own tobacco); and (3) prohibition of vending machine sales of such products unless the vending machine is located in a facility where the retailer ensures that individuals under the age of 18 are prohibited from entering at any time. Prior to this Final rule, there was no federal law prohibiting retailers from selling e-cigarettes, hookah tobacco, or cigars to people under 18. The Final rule includes provisions including prohibiting sale to persons under the age of 18 in person and online and requiring age verification by photo ID. The rule also disallows the distribution of free samples.
Components and parts versus accessories. Under the Final rule, “component or part” means “any software or assembly of materials intended ore reasonably expected: (1) to alter or affect the tobacco product’s performance, composition, constituents, or characteristics; or (2) to be used with or for the human consumption of a tobacco product.” Components include e-liquids, atomizers, flavors, and cartomizers (atomizers plus replaceable fluid-filled cartridge). “Accessories” that are not regulated under the Final rule include ashtrays, hookah tongs, and cigar clips, as they do not contain tobacco, are not derived from tobacco, and do not affect or alter the performance, composition, constituents, or characteristics of a tobacco product.
Effective dates. The deeming provisions, minimum age and identification provisions, and vending machine restrictions are effective 90 days from the date of publication. Health warning requirements are effective 24 months from the date of publication of the Final rule, with an additional 30-day period in which the manufacturer may continue to introduce into interstate commerce existing inventory manufactured before the effective date if the product does not contain the required warning statements. This Final rule was previously released as a Proposed rule (see E-cigarette regulations would ban sales to minors, require health warnings, April 25, 2014).
User fees. The FDA concurrently released a Final rule requiring domestic manufacturers and importers of cigars and pipe tobacco to submit information needed to calculate the amount of user fees assessed under the FDC Act, as required under the new rule deeming these products to be under FDA authority.
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