FDA WARNING_LETTER - Electronic Puffs - May 12, 2020

The FDA Center for Tobacco Products issued a Warning Letter to Electronic Puffs on April 22, 2020, following a review of their website, https://www.electronicpuffs.com. The review determined that the company offers Electronic Nicotine Delivery System (ENDS) products for sale or distribution in the U.S., which are regulated as tobacco products under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The primary violation identified is the sale of "myblu Cherry Liquidpods" without the required premarket marketing authorization. This product is considered a "new tobacco product" because it was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order or exemption. Consequently, the product is deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act, due to the absence of required information under section 905(j).

Electronic Puffs is required to promptly correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in enforcement actions, including civil money penalties, seizure, and/or injunction. The company must submit a written response within 15 working days detailing corrective actions, including dates of discontinued sales and a plan for future compliance.