FDA WARNING_LETTER - The Smoker's Alternative - May 11, 2021

The FDA Center for Tobacco Products issued a Warning Letter to The Smoker’s Alternative after reviewing submissions and inspection records, determining the firm manufactures and distributes e-liquid products, specifically "The Smoker’s Alternative Vanilla Custard 60 ml 3mg e-liquid product," which are deemed tobacco products subject to FDA regulation. The primary violation is the sale and distribution of this e-liquid product without the required premarket marketing authorization order, as it is considered a "new tobacco product" not commercially marketed before February 15, 2007. Consequently, the product is 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 information under section 905(j). The firm's actions constitute prohibited acts under sections 301(k) and 301(p) of the FD&C Act. The FDA requires a written response within 15 working days detailing corrective actions, including dates of discontinued sales/distribution, and a plan for maintaining compliance. Failure to address these violations may result in regulatory actions such as civil money penalties, seizure, or injunction.