The U.S. Food and Drug Administration (FDA) has issued two final rules for premarket review of new tobacco products. These rules clarify requirements for content, format and review of Premarket Tobacco Product Applications (PMTAs) and Substantial Equivalence (SE) Reports – two of the most commonly used pathways through which a manufacturer can seek marketing authorization for a new tobacco product.
The finalization of these rules helps ensure that all future submissions include information needed to determine whether a new product meets relevant premarket requirements according to the Family Smoking Prevention and Tobacco Control Act.
The rules include no substantive changes. Both final rules will publish Oct. 5 and will be effective Nov. 4. Under the PMTA pathway, manufacturers or importers must demonstrate that marketing of the new tobacco product(s) would be “appropriate for the protection of the public health.”
That standard requires the agency to consider risks and benefits to the population as a whole including both users and non-users of tobacco products.
The agency’s evaluation includes review of the product’s ingredients, additives, constituents, toxicological profile and health impact, as well as how the product is manufactured, packaged and labeled, as well as findings from any consumer perception research and description of marketing plans for the product.
In addition to these rules, the FDA is moving toward product standards that would ban menthol flavor in cigarettes and ban all non-tobacco characterizing flavors (including menthol) in cigars. Those standards will be based on evidence establishing addictiveness and increased appeal of these products. There is also strong evidence that a ban on menthol in cigarettes will help people quit.
