Any New NTN Product Without FDA Premarket Approval Cannot Be Sold.

On March 15, 2022, new federal legislation will give the FDA the authority to regulate nicotine-containing tobacco products from any source. The law goes into effect on April 14, 2022, and after July 13, 2022, any new NTN goods without FDA premarket approval cannot be marketed lawfully. 

The FDA has received approximately one million NTN submissions from over 200 firms.  According to the agency, all applications filed before May 14 have been handled, and more than 85 percent have been evaluated to see if they fulfill the minimal standards for further assessment. Among all, FDA has issued a rejection of acceptance (RTA) letter for over 800,000 NTN products whose applications did not fulfill approval requirements. 

The FDA has accepted over 350 applications for NTN products, the majority of them for electronic cigarettes or e-liquids. Acceptance is not a decision of a product's authorized status, the agency underlined. "Accepted applications will continue to further evaluation, which will verify that certain criteria are satisfied prior to further examination of the application." 

Since President Biden signed legislation empowering the FDA to regulate tobacco products containing nicotine from any source, the agency has issued over 44 warning letters to producers and over 300 warning letters to retailers for breaches involving non-tobacco nicotine (NTN) products. In addition, the FDA has issued fresh warning letters to 102 merchants who offered NTN goods to minors in violation of the law.