FDA WARNING_LETTER - Hazetown Vapes Inc. - December 12, 2019

The FDA issued a Warning Letter to Hazetown Vapes (Philip Clementina, David Gray, and Tobias Medeiros) on December 12, 2019, after reviewing their website, hazetownvapes.com. The FDA determined that e-liquid products advertised and sold to U.S. customers are tobacco products under the FD&C Act.

The primary violation identified is that the website advertising for several e-liquid products, such as Dinner Lady Apple Sours Salt Nic and Dinner Lady Watermelon Slices Nic Salt, fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." This omission renders the products misbranded under sections 903(a)(7)(B) and 903(a)(7)(A) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B) and § 387c(a)(7)(A)), and in violation of 21 C.F.R. § 1143.3(b). The FDA considers the lack of this material fact in advertising to be misleading.

Hazetown Vapes is required to immediately correct these violations and ensure all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all platforms. Failure to comply may result in civil money penalties, no-tobacco-sale