FDA WARNING_LETTER - Vapin By The Beach

The FDA Center for Tobacco Products issued a Warning Letter to Dawn Higgins of Vapin By The Beach after reviewing their website, http://www.vapinbythebeach.com, and determining that e-liquid products were offered for sale in the United States. The FDA classified these e-liquids as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of Vapin By The Beach Captain America e-liquid to a person younger than 18 years of age, which constitutes misbranding under section 903(a)(7)(B) of the FD&C Act. This violates 21 C.F.R. § 1140.14(b), which prohibits the sale of covered tobacco products, including e-liquids, to minors. The letter clarifies that e-liquids are "covered tobacco products" under 21 C.F.R. § 1100.2.

The FDA requires immediate correction of this violation and any similar issues to ensure compliance with the FD&C Act. Failure to comply may result in further actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales and a plan for maintaining compliance, is required within 15 working days.