FDA Made Decision on 99% of E-cigarette PMTA Applications

On March 15, the U.S. Food and Drug Administration (FDA) said it had made decisions on more than 99 percent of the nearly 26 million considered tobacco products submitted for premarket tobacco product applications (PMTAs). The agency has previously said reviews of some of the most popular vaping products could take until the end of the year.

The FDA also said it issued a refusal to accept (RTA) letter to one applicant on February 21, informing a company that their PMTAs were associated with approximately 17 million tobacco products and did not comply with FDA 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 FDA stated.

The agency's overall decision included the following:

• Authorizing 23 new vaping products and devices
• Sending refuse-to-submit (RTA) letters
• Marketing denial orders for millions of products

These data include the determination of nearly 6.7 million product applications received before September 9, 2020, more than 18 million after September 9, and nearly 1 million applications for non-tobacco nicotine products filed by May 14, 2022, after the new federal law passed in April 2022.

According to the order of the Federal Court, manufacturers of designated new tobacco products that were already on the market on the effective date of the established rules (August 8, 2016) are required to submit applications for premarket review by September 9, 2020.

The original text of the FDA is as follows: 

Reference:

U.S. FDA has Made Decisions on Over 99 Percent of PMTAs

FDA Makes Determinations On More Than 99% of the 26 Million Tobacco Products For Which Applications Were Submitted