Lingkey Co. Ltd. d/b/a Vape Hammer – FDA Warning Letter, Nov 16, 2023

On November 16, 2023, the FDA issued a Warning Letter to Vapehammer.com after reviewing their website and determining they offer Electronic Nicotine Delivery System (ENDS) products for sale in the U.S. These products are considered tobacco products under the FD&C Act, specifically section 201(rr), due to containing nicotine.

The primary violation identified is the marketing of "new tobacco products" without required premarket authorization, as mandated by section 910(a) of the FD&C Act. The specific product cited is the "DO3 disposable" ENDS product, which was not commercially marketed in the U.S. as of February 15, 2007, and lacks an FDA marketing authorization order. Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act.

The FDA expressed additional concern that the DO3 products' labeling and advertising imitate soda drinks and their design helps conceal their nature as tobacco products, potentially promoting youth use.

Vapehammer.com is required to submit a written response within 15 working days detailing actions taken to address the violations, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, and/or injunction.