FDA WARNING_LETTER - Atmos Nation LLC d/b/a AtmosRx - April 07, 2020

The FDA's Center for Tobacco Products issued a Warning Letter to Charly Benassayag and Eli Eroch regarding e-liquid products advertised and sold on atmosrx.com. The FDA determined these e-liquids are tobacco products under section 201(rr) of the FD&C Act. The primary violation is that several e-liquid products are misbranded under section 903(a)(7)(B) of the FD&C Act because their advertising on the website fails to include the required nicotine warning statement, as mandated by 21 C.F.R. § 1143.3(b). Specifically, the advertising did not bear the warning: "WARNING: This product contains nicotine. Nicotine is an addictive chemical." The letter emphasizes that e-liquids are considered "covered tobacco products" subject to these regulations. The company must immediately correct these violations and submit a written response within 15 working days, detailing corrective actions, dates of discontinuing violative advertising/sales, and a plan for future compliance. Failure to comply may result in severe FDA enforcement actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, injunction, and detention of imported products.