Everything Vapor Aztec – FDA Warning Letter, Jun 8, 2023

On June 8, 2023, the FDA issued a Warning Letter to Everything Vapor, specifically addressing Ms. Garrison, regarding the manufacture and distribution of e-liquid products. The FDA determined that Everything Vapor's e-liquid products, including "House Juice #11 Blackberry," are "tobacco products" under section 201(rr) of the FD&C Act, as 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. A "new tobacco product" is defined as any tobacco product not commercially marketed in the U.S. as of February 15, 2007, or any modified product marketed after this date. The FDA found that Everything Vapor's e-liquid products were not commercially marketed by the specified date and lack the necessary marketing authorization orders (e.g., under section 910(c)(1)(A)(i) or substantial equivalence exemptions).

Consequently, these products are deemed adulterated under section 902(6)(A) and misbranded under section 903(a)(6) of the FD&C Act due to the lack of required notice or information under section 905(j). The failure to provide such reports is a prohibited act under section 301(p), and any act resulting in adulterated or misbranded products