FDA Issues 2 Final Rules for Premarket Review of Tobacco Products

Agency has issued 232 marketing denial orders
ENDS products
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration (FDA) has issued two final rules for the premarket review of new tobacco products.

The rules provide additional information on the requirements for the content, format and review of premarket tobacco product applications (PMTAs) and substantial equivalence (SE) reports.

“The finalization of these rules helps ensure that all future submissions contain the basic information needed to determine whether the new tobacco products meet the relevant premarket requirements to efficiently and effectively implement the Family Smoking Prevention and Tobacco Control Act,” the FDA said in an announcement Monday.

No significant changes were made from the previous versions of the rules, the FDA said. Both final rules were published on Tuesday and are effective Nov. 4. More information can be found on the FDA’s website.

The announcement comes as the agency continues to review PMTAs submitted by the Sept. 9, 2020, deadline. As of Sept. 23, the FDA has issued a total of 232 marketing denial orders (MDOs) accounting for more than 1.2 million flavored electronic nicotine delivery system (ENDS) products.

Products subject to an MDO may not be introduced or delivered for introduction into interstate commerce. If a product is already on the market, it must be removed or risk enforcement, the FDA said. The MDOs and other enforcement actions are summarized on the FDA’s Tobacco Product Applications: Metrics and Reporting page, which is regularly updated.

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