FDA WARNING_LETTER - BFL Metal Products Co., LTD - October 30, 2024

The FDA's Center for Tobacco Products issued a Warning Letter to Liang Lihong on October 30, 2024, after reviewing fumevapors.com and determining that the firm manufactures and sells electronic nicotine delivery system (ENDS) products in the U.S. These products, including "WeFume Vape 30K Puffs – Lychee Soda" and "WeFume Vape 30K Puffs – Apple Pineapple," are considered "new tobacco products" under the FD&C Act, which now includes products with nicotine from any source. The FDA found that these products lack the required premarket authorization order, rendering them adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act. The FDA expressed particular concern regarding the products' design, which imitates smartphones, potentially appealing to youth and aiding in concealment. The firm is required to submit a written response within 15 working days detailing corrective actions, including discontinuing sales and a plan for future compliance. Failure to comply may result in regulatory actions such as civil money penalties, seizure, injunction, or import detention.