FDA WARNING_LETTER - Blacksmith ELiquid - March 26, 2019

On March 6, 2019, the FDA issued a Warning Letter to Faction Industries, LLC, d/b/a Blacksmith E-Liquid, following a review of their website, http://blacksmitheliquid.com. The FDA determined that Blacksmith Damascus e-liquid, a tobacco product under section 201(rr) of the FD&C Act, was misbranded.

The violation stemmed from the sale of Blacksmith Damascus e-liquid to a person younger than 18 years of age, which contravenes 21 C.F.R. § 1140.14(b). This regulation prohibits retailers from selling covered tobacco products, including e-liquids, to minors. The FDA cited section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)), which states that tobacco products are misbranded if sold in violation of regulations prescribed under section 906(d) of the FD&C Act, including 21 C.F.R. Part 1140.

Faction Industries, LLC, was instructed to immediately correct this violation and any similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales channels. Failure to comply could result in civil money penalties, no-