Q&A: Tobacco Product Review and Evaluation – Pathways to Market
- What is a tobacco product?
- What is a new tobacco product?
- What is an additive?
- What is a tobacco product manufacturer?
- How may a manufacturer legally begin marketing a new tobacco product in the United States?
- What if my new tobacco product was introduced into interstate commerce for commercial distribution between February 15, 2007, and March 22, 2011?
The Federal Food, Drug and Cosmetic Act (FD&C Act) defines a tobacco product as “any product made or derived from tobacco, or containing nicotine from any source, that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)” but does not include a drug, a device, or a combination product, or a food if it contains no nicotine or no more than trace amounts of naturally occurring nicotine (Section 201(rr) of the FD&C Act).
A new tobacco product is defined under Section 910(a)(1) of the FD&C Act as:
- Any tobacco product (including those products in test markets) that was not commercially marketed in the United States as of February 15, 2007; or
- Any modification (including one with a change in design, any component, any part, or any 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 United States after February 15, 2007.
Additive is defined in the FD&C Act as any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any tobacco product. This includes any substance intended for use as a flavoring or coloring or in producing, manufacturing, packing, processing, preparing, treating, packaging, transporting, or holding. The term additive does not include tobacco or a pesticide chemical residue in or on raw tobacco or a pesticide chemical (Section 900(1)).
A tobacco manufacturer is anyone who manufactures, fabricates, assembles, processes, or labels a tobacco product. This includes repackers, relabelers, and those who import a finished tobacco product for sale or distribution in the United States. (Section 900(20)).
There are three pathways by which a manufacturer may legally market a new tobacco product in the United States:
- Submit to FDA a Premarket Tobacco Application (PMTA) under Section 910 (b) and obtain a written order permitting marketing of the new tobacco product;
- Submit a Substantial Equivalence Report to FDA and obtain an order finding the product to be substantially equivalent to a predicate tobacco product (Section 905(j)(1)(A)(i)) and in compliance with the requirements of the Act;
- Submit to FDA a request for an exemption from the substantial equivalence requirements, obtain an exemption (Section 905(j)(3), 21 CFR 1107.1), and then submit a report as described in Section 905(j)(1)(A)(ii) of the FD&C Act at least 90 days before commercially marketing your product.
What if my new tobacco product was introduced into interstate commerce for commercial distribution between February 15, 2007, and March 22, 2011?
If the product was introduced into interstate commerce between February 15, 2007, and March 22, 2011, a manufacturer must have submitted a Substantial Equivalence Report to FDA by March 22, 2011, for its product to remain on the market while FDA completes its review of the Substantial Equivalence Report.
This web content highlights provisions of the Food, Drug and Cosmetic Act (FD&C Act). It is not intended to be comprehensive or reflect FDA's interpretation of the Act. For complete information, you must read the entire law. For your convenience, the section number of the FD&C Act is referenced and relevant sections are linked to throughout the web content.