FDA WARNING_LETTER - Alchem USA

The FDA issued a Warning Letter to Alchem International, citing violations related to the sale, manufacture, or distribution of tobacco-derived liquid nicotine and other nicotine products through their websites, http://www.alcheminternational.com and http://www.nicselect.com. The products, including various concentrations of liquid nicotine, are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation, under section 301(tt) of the FD&C Act (21 U.S.C. 331(tt)), concerns express or implied statements directed to consumers that mislead them into believing the products are FDA-approved, deemed safe, endorsed by the FDA, or safer due to FDA regulation or inspection. Specifically, the websites repeatedly state that Alchem International is an "FDA-inspected manufacturer" and that NicSelect is produced in an "FDA-inspected facility," including references to an "FDA Inspection Letter" and customer testimonials. The Alchem International website also claimed their nicotine was manufactured at a "US FDA approved pharmaceutical production plant."

The FDA requires immediate correction of these violations and similar issues, ensuring all tobacco products and promotional materials comply with the FD&C Act. Failure to comply may result in further action, including civil money penalties, criminal prosecution, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative promotions, and a plan for maintaining compliance,