What is PMTA?

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). 

PMTA, whose full name is PremarketTobacco Product Application, means "Premarket Tobacco Product Application", and the U.S. Food and Drug Administration (FDA) began to implement a marketing certification system for tobacco products on September 9, 2020. This means that tobacco products will not be available for sale in the future. Simply put, in the future, tobacco products, especially the electronic cigarette, whether open e-cigarette, closed e-cigarette, e-cigarette oil, or heated non-combustible, as well as various types of tobacco products, will be the same as pharmaceuticals and medical devices, and the FDA will need to conduct a series of evaluations of the product and the product's manufacturing plant before it is officially listed in the U.S. market, through the manufacturer's "The FDA has to verify that the product is reliable and stable, and that the product itself is safe, and that the harm to the user or person exposed to it is within acceptable limits.

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 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 on the conditions mentioned above.

 Published by: https://www.fda.gov/