FDA WARNING_LETTER - Mery Vape - September 12, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Meryvape.com after determining that it offers electronic nicotine delivery system (ENDS) products for sale or distribution to U.S. customers via its website. These products, including specific Mr. Fog Disposable, Mini Disposable, and Max Air Disposable variants, are classified as "new tobacco products" under section 201(rr) of the FD&C Act, especially considering the expanded definition to include nicotine from any source. The primary violation is the marketing of these new tobacco products without the required premarket authorization order, as mandated by section 910(a) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). Meryvape.com must submit a written response within 15 working days, detailing actions taken to address violations, including discontinuing violative sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or detention/refusal of imports.