FDA Makes ‘Significant Progress’ on Synthetic Nicotine PMTAs

In total, the agency has issued refuse-to-accept letters for more than 800,000 new non-tobacco nicotine products.

September 12, 2022

WASHINGTON—The U.S. Food and Drug Administration (FDA) announced it is making “significant progress” in processing and reviewing non-tobacco nicotine product premarket applications. According to the agency, to date, all applications submitted by May 14 have been processed, and more than 85% have been reviewed to determine if they meet the minimum requirements to be accepted for further review.

In total, FDA has issued refuse-to-accept (RTA) letters for more than 800,000 new non-tobacco nicotine (NTN) products in applications that do not meet the criteria for acceptance; this includes more than 700,000 new RTAs since August 3. The RTA letters state that it is illegal to sell or distribute in the U.S. marketplace any new tobacco product that has not received premarket authorization.

In March, legislation was passed that gave the FDA authority to regulate synthetic nicotine products and required any manufacturers of synthetic nicotine that wanted to market their products to submit a premarket tobacco application (PMTA) by May 14, 2022, and obtain FDA authorization to stay on the market after July 13, 2022. This law took effect April 14, 2022, and after July 13, 2022, any new non-tobacco nicotine (NTN) product that has not received premarket authorization from FDA cannot be legally marketed.

The FDA said a “substantial number” of NTN applications were submitted by May 14—nearly one million from more than 200 separate companies. Preparing these applications for review takes several steps, and submissions varied widely in their organization, size and completeness of data, which impacts the time it takes to process the information, according to the FDA.

In total, the agency has accepted over 350 applications for NTN products, with the vast majority being for e-cigarette or e-liquid products. Acceptance is not a determination about the products’ authorization status, FDA says. Accepted applications will enter further review, which ensures certain criteria are met for applications to proceed with further review.

In total, FDA has issued 44 warning letters to manufacturers and over 300 warning letters to retailers for violations in relation to NTN products. Failure to promptly correct violations can result in further action such as civil money penalties, seizure and/or injunction, says the FDA.

These numbers include 25 new warning letters to manufacturers of NTN products issued since August 3 for marketing their products without the required premarket authorization. These manufacturers failed to submit applications for their NTN products. Additionally, FDA has issued new warning letters to 102 retailers for illegally selling NTN products to underage purchasers.

To keep stakeholders and the public informed, FDA recently launched a non-tobacco nicotine product webpage that includes up-to-date information about premarket review progress and compliance and enforcement actions.

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