Under federal law, including Section 910(b) of the Federal Food, Drug, and Cosmetic (FD&C) Act, any company looking to launch and market a new tobacco product in the United States must submit a Premarket Tobacco Product Application (PMTA) to the Food and Drug Administration (FDA).
Passed in 2007, the regulation also applies to any existing tobacco product that undergoes any change in design, ingredients or components. The PMTA process was put in place to assess the potential negative public health impact of new products such as e-cigarettes. PMTA submissions were due by September 9, 2020.
The FDA considers several key factors as it reviews whether to approve the sale of a new or modified tobacco product. They include:
- Risks and benefits to the population as a whole, including people who would use the proposed new tobacco product as well as nonusers;
- Whether people who currently use any tobacco product would be more or less likely to stop using such products if the proposed new tobacco product were available; and
- Whether people who currently do not use any tobacco products would be more or less likely to begin using tobacco products if the new product were available
The FDA is reviewing each PMTA in detail to determine the public health risk factors associated with each application. PMTA approval must be granted before any new tobacco product can be sold in the U.S.
- The FDA emphasizes clearance does not mean a product is “safe”, “FDA-approved” or a “cessation device.” These terms cannot be used in its marketing.
- The FDA reiterates that all tobacco products are harmful and addictive and those who do not use tobacco products should not start.
- The FDA reserves the right to withdraw market sales approval if the Agency determines the continued marketing of a product is no longer appropriate for the protection of the public health, for example, as a result of significant uptake of the product by youth.
Of more than one million applications received, only very few – far less than 1/10 of 1% – have been granted permission to enter the market under this new arrangement.
The FDA maintains a regularly updated list of which brands and product names have received Premarket Tobacco Product Marketing Granted Orders, permitting sale contingent to the conditions mentioned above.