FDA WARNING_LETTER - Bad Drip Labs Inc. - May 29, 2025

On May 29, 2025, the FDA Center for Tobacco Products issued a Warning Letter to Bad Drip Labs Inc. following a review of inspection records. The letter states that Bad Drip Labs Inc. sells and/or distributes e-liquid products, including "Bad Drip Sweet Tooth 60mL, 3mg," which are classified as tobacco products under section 201(rr) of the FD&C Act (21 U.S.C. § 321(rr)) because they contain nicotine from any source and are intended for human consumption.

The primary violation identified is the marketing of "new tobacco products" without the required premarket authorization order. These products are considered "new" because they were not commercially marketed in the U.S. as of February 15, 2007, and lack an FDA marketing authorization order under section 910(c)(1)(A)(i) of the FD&C Act (21 U.S.C. § 387j(c)(1)(A)(i)), nor are they exempt. Consequently, these products are deemed adulterated under section 902(6)(A) (21 U.S.C. § 387b(6)(A)) and misbranded under section 903(a)(6) (21 U.S.C. § 3