FDA Reviews 99% of Tobacco Applications

Agency rejects e-liquid company’s PMTA, associated with about 17 million products
E-cigarette user
Photograph: Shutterstock

The Food and Drug Administration has made determinations on more than 99% of the nearly 26 million deemed tobacco products for which applications were submitted, the agency announced Wednesday. Those determinations include the agency authorizing 23 new e-cigarette products and issuing refuse to accept (RTA) letters, refuse to file letters or marketing denial orders (MDOs) for millions of products.

These products the FDA is reviewing come from three application pools:

  • Premarket tobacco product applications (PMTAs) received by the Sept. 9, 2020, deadline, totaling nearly 6.7 million products.
  • PMTAs for more than 18 million products received after the Sept. 9, 2020, deadline.
  • PMTAs for nearly 1 million non-tobacco nicotine products submitted by May 14, 2022, after the FDA received regulatory authority over tobacco products that contain synthetic nicotine.

The FDA has said it will need through 2023 to finish its PMTA review.

In one of the FDA’s most recent rejections, the agency notified a company that their PMTAs, which are associated with about 17 million individual tobacco products, do not meet the acceptance requirements outlined in the FDA’s regulations. The applications were for a grouped submission of e-liquids in varying size, nicotine strength and flavor combinations, each of which was treated as an individual product application according to existing premarket review processes.

The company was issued an RTA letter because its applications lacked required environmental assessments, the FDA said. The company can submit a new application for these products at any time, but the products cannot currently be marketed.

“Due to potential confidential commercial information (CCI) issues, FDA cannot provide the applicant name or specific product names,” an FDA spokesperson told CSP Daily News.  

RTA letters are issued when the Center for Tobacco Products did not accept a marketing application because a preliminary administrative review concludes that it has not met a minimum threshold for acceptability for FDA review. MDOs are issued after the CTP has reviewed an application and determined the marketing of a new tobacco product is not appropriate for the protection of public health.

Companies that receive MDOs can be found on a regularly updated list on the agency’s website.

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