FDA oversees all pathways to legally market and distribute tobacco products in the U.S. Determine an appropriate pathway to market for your tobacco product and learn more about how the FDA reviews and evaluates marketing order applications.
Introduce a New Tobacco Product to Market
Before introducing a new tobacco product to the U.S. market, a company must submit a marketing application to the FDA and receive authorization.* A “new tobacco product” is defined as any product not commercially marketed in the U.S. as of Feb. 15, 2007, or the modification of a tobacco product where the modified product was commercially marketed in the U.S. after Feb. 15, 2007.** These new products and their applications are comprehensively evaluated by FDA scientists, who determine whether or not the application proves the new tobacco product meets the appropriate statutory standards.
New tobacco products on the market without the required premarket authorization are marketed unlawfully and subject to enforcement action at the FDA’s discretion.
There are three pathways to market for new tobacco products:
Premarket Tobacco Product Applications (PMTA)
A PMTA must demonstrate the new tobacco product would be “appropriate for the protection of the public health” and takes into account the increased or decreased likelihood that existing users of tobacco products will stop using such products, as well as the increased or decreased likelihood that those who do not use tobacco products will start using such products.
Substantial Equivalence (SE)
A new tobacco product may be found “substantially equivalent,” to a “predicate” product by demonstrating the product has the same characteristics as that predicate product, or if the product has different characteristics, by demonstrating that the new product does not raise different questions of public health than the predicate product.
Request Exemption from Demonstrating Substantial Equivalence (EX REQ)
A tobacco product that is modified by adding or deleting a tobacco additive, or by increasing or decreasing the quantity of an existing tobacco additive may be considered for an exemption from demonstrating substantial equivalence.
Historically, the applications accepted through the SE and Exemption Request pathways have been for cigarettes, cigars, hookah tobacco, roll-your-own tobacco, smokeless tobacco products, and rolling papers. The PMTA pathway has accepted applications for all classes of tobacco products. To date, no valid pre-existing ENDS product has been identified, and all premarket applications for ENDS products accepted by the FDA have been through the PMTA pathway.
However, those seeking to market a new tobacco product may submit an application through any of the three pathways and are encouraged to contact FDA to discuss the most appropriate pathway to market for their product.
Applicants may appeal a decision, in writing, to the next supervisory level in the chain of command within the agency by submitting a supervisory review request. The Supervisory Review/Appeal Process for Tobacco Product Decisions webpage highlights the supervisory review process, what types of submissions are accepted, and who to contact if you have further questions about supervisory review.
Resources for Small Businesses
Small tobacco product retailers and manufacturers, including vape shops, sometimes have fewer resources and face different challenges than larger businesses. However, like large businesses, small tobacco manufacturers seeking to introduce a new tobacco product to the market must comply with the Tobacco Control Act and related regulations.
If you are a small business interested in introducing a new tobacco product to the market, CTP’s Office of Small Business Assistance (OSBA) is available to help, including questions about helpful resources such as Tobacco Product Master Files and Electronic Submissions for Tobacco Products.
*New tobacco products commercially marketed after Feb. 15, 2007 but before March 22, 2011 with an SE Report submitted by March 22, 2011 are known as provisional SE tobacco products— these may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent. Per a court ruling issued Aug. 19, 2020, FDA will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by Sept. 9, 2020. **Products on the market as of or on Feb. 15, 2007 are considered pre-existing, or grandfathered, tobacco products.
*New tobacco products commercially marketed after Feb. 15, 2007 but before March 22, 2011 with an SE Report submitted by March 22, 2011 are known as provisional SE tobacco products— these may continue to be marketed unless FDA issues an order that the new product is not substantially equivalent. Per a court ruling issued Aug. 19, 2020, FDA will not enforce the premarket review requirement against manufacturers of premium cigars that do not submit premarket applications for these products by Sept. 9, 2020.
**Products on the market as of or on Feb. 15, 2007 are considered pre-existing, or grandfathered, tobacco products.