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
A “new tobacco product” is any product not commercially marketed in the United States as of February 15, 2007, or the modification of a tobacco product where the modified product was commercially marketed in the U.S. after February 15, 2007.
Products on the market as of or on February 15, 2007 are considered grandfathered tobacco products.
New tobacco products may not be legally marketed in the United States without a tobacco product marketing order from the FDA.* These products are evaluated based on the product's risks to the population as a whole. There are three pathways to market for new tobacco products:
- Premarket Tobacco Product Applications
A premarket tobacco product application may be submitted when seeking marketing authorization for any new tobacco product. However, for some products, other pathways may be more applicable.
- Substantial Equivalence
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
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.
*New tobacco products commercially marketed after February 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.
- Oct. 22-23, 2018: Public Meeting — Tobacco Product Application Review
- Oct. 28-29, 2019: Public Meeting — Deemed Tobacco Product Applications
- Family Smoking Prevention and Tobacco Control Act - An Overview
- Small Business Assistance for Tobacco Product Industry
- Tobacco Product Master Files