FDA Continues to Implement Law Regarding Non-Tobacco Nicotine Products
Agency takes action on pending applications and issues warning letters to firms not in compliance with the law
On March 15, 2022, a new federal law gave FDA the authority to regulate tobacco products containing nicotine from any source. 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. Below are the latest updates on the implementation of the new federal law as well as our latest compliance and enforcement activities related to NTN products.
A substantial number of NTN applications were submitted by May 14 – nearly one million from more than 200 separate companies – with some several thousand pages long. 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.
FDA is making significant progress in processing and reviewing these applications. To date, all applications submitted by May 14 have been processed, and more than 85 percent 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 NTN products in applications that do not meet the criteria for acceptance; this includes more than 700,000 new RTAs since Aug. 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 total, FDA 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. 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. These numbers include 25 new warning letters to manufacturers of NTN products issued since Aug. 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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