FDA WARNING_LETTER - Beachside Vapors LLC - May 10, 2022

The FDA's Center for Tobacco Products issued a Warning Letter to Beachside Vapors LLC following a review of their website, https://www.beachsidevapors.com. The FDA determined that the e-liquid products, specifically "Maui Wowie" and "Rainbow Fluff," are tobacco products under section 201(rr) of the FD&C Act and are subject to FDA regulation, including the requirement for premarket authorization for "new tobacco products." The inspection revealed that Beachside Vapors is manufacturing and offering these e-liquid products for sale or distribution in the United States without the necessary FDA marketing authorization order, as required by section 910(c)(1)(A)(i) of the FD&C Act. Consequently, these products are deemed adulterated under section 902(6)(A) of the FD&C Act and misbranded under section 903(a)(6) of the FD&C Act, due to the failure to provide required notice or information under section 905(j). The FDA mandates that all new tobacco products on the market without statutory premarket authorization are unlawful. Beachside Vapors is required to submit a written response within 15 working days detailing corrective actions, including the discontinuation of violative sales and a plan for maintaining compliance with the FD&C Act and related regulations (21 C.F.R. Parts 1140, 1141, and 1143). Failure to comply may result in significant regulatory actions, such as civil money penalties, product seizure, or injunction.