FDA Drops 7 More Warning Letters, Total Now 111

The U.S. Food and Drug Administration (FDA) issued seven more warning letters to vapor companies for selling illegal products. The total now stands at 111 for the number of warning letters the regulatory agency has issued to vapor companies in 2021. The FDA accuses the companies of selling vapor products without having submitted a premarket tobacco product application (PMTA) by Sept. 9, 2020.

The companies all received their letters on May 7, however the FDA didn’t post the letters on its website until May 18. The companies receiving letters include:

• Nicotine Nirvana, which has over 50 products registered with the FDA;
• FF Vapors, which has over 257,000 registered products with the FDA;
• JP & SN Enterprises Inc. d/b/a eCigs International, which has over 4,500 products listed with the FDA;
• The Iron Crow, which has 400 products listed with the FDA;
• Sema International, which has over 500 products listed with the FDA;
• Central Iowa Electronic Cigarettes, which has over 3,400 products listed with the FDA;
• High Voltage Vaporz, which has over 600 products registered with the FDA.

The FDA often only lists a few products that a company is selling as illegal in the letter. It then states that there may be more, but it is impossible to know if the warnings encompass all the company’s registered products. The agency states that it is the responsibility of the company to only sell products with a submitted PMTA. Companies have until Sept. 9, 2021 to sell product unless the agency makes a decision on the PMTA approval or grants an extension.

Companies that receive warning letters from the FDA have to submit a written response to the letter within 15 working days from the date of receipt describing the company’s corrective actions, including the dates on which it discontinued the violative sale, and/or distribution of the products. They also require the company’s plan for maintaining compliance with the FD&C Act in the future.