FDA WARNING_LETTER - Vapestar

The FDA's Center for Tobacco Products issued a Warning Letter to Vapestar.com after reviewing their website and determining that e-liquid products were offered for sale in the U.S. 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 Atmos E Cig Melon Bash 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.

Vapestar is required to immediately correct this violation and any similar issues to ensure compliance with the FD&C Act and FDA's implementing regulations. Failure to comply may result in further FDA actions, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. Adulterated and misbranded tobacco products imported into the U.S. are also subject to detention.

Vapestar must submit a written response within 15 working days detailing their corrective actions, including dates of discontinued violative sales/advertising, and their plan for maintaining compliance. The reference number for the response is RW1800893.