- FDA has the authority to regulate various tobacco products (cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco) under the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act of 2009 (Tobacco Control Act). A “new tobacco product” is defined, in pertinent part, as any tobacco product that was not commercially marketed in the United States as of February 15, 2007 (i.e., is not grandfathered); or any modification (including a change in any design, component, part, constituent, including a smoke constituent, or in the content, delivery or form of nicotine, or any other additive or ingredient) of a tobacco product where the modified product was commercially marketed in the U.S. after the February 15, 2007 grandfather date.
- There are three distinct methods by which manufacturers may obtain marketing authorization to introduce new tobacco products into interstate commerce: (1) submission of a Premarket Tobacco Product Application (PMTA); (2) submission of a Substantial Equivalence (SE) Report comparing the new product to a valid grandfathered (predicate) product; and (3) submission of a request for an exemption from SE requirements for minor modifications.
- Under the more onerous PMTA pathway, manufacturers must demonstrate (among other things) that the marketing of the new tobacco product would be appropriate for the protection of the public health. To enforce this standard, FDA must consider the risks and benefits to the population as a whole, including users and non-users of tobacco products.
- On November 10, 2015, FDA issued its first market authorizations in response to PMTAs. Specifically, the Agency has authorized the marketing of eight snus smokeless tobacco products. In its press release announcing the authorizations, FDA reiterates that its action does not mean the products are “safe” or “FDA approved.” In fact, the Tobacco Control Act makes clear that companies cannot position their products as “FDA approved.” Also, companies must separately apply for, and receive, a separate modified risk tobacco product (MRTP) authorization to permit claims of reduced exposure or reduced risk. The current PMTA actions are marketing authorizations and do not constitute MRTP authorizations.
- FDA’s actions have set long-awaited precedent that should give the tobacco industry insight into how FDA intends to evaluate PMTAs and what final marketing orders will look like.
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