Under FDA’s premarket tobacco product application (PMTA) pathway, manufacturers or importers of tobacco products must demonstrate to the U.S. Food and Drug Administration (FDA) that the marketing of a new tobacco product would be appropriate for the protection of the public health (APPH).
See Section 910(c)(2)(A) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the Family Smoking Prevention and Tobacco Control Act (TCA).
This statutory threshold standard requires that FDA consider the risks and benefits of the product to the population as a whole, including users and non-users of tobacco products.
The Agency’s risk-benefit analysis includes evaluating the impact of the product, both the likelihood that existing users will stop using such products and the likelihood that non-users, particularly youth and vulnerable populations, will start using such products. In its evaluation of whether a product is appropriate for the protection of the public health, the Agency reviews a product’s components, ingredients, additives, constituents, health risks, the manufacturing process, and the product’s packaging and labeling. If FDA concludes that the benefits outweigh the risks, it may authorize the product for marketing, which the Agency notes is different from the approvals that it issues for drugs or medical device products. Under the provisions of Section 910 of the FD&C Act, an issuance of a marketing granted order allows the introduction into interstate commerce of the tobacco products.
Azim Chowdhury, Josephine Hsu & LieAnn T. Van-Tull – Continuum of Risk – 2022-04-08.