FDA WARNING_LETTER - Shisha Pen Shop

The FDA's Center for Tobacco Products issued a Warning Letter to Shishapendirect.com after reviewing their website and determining that e-liquid products were offered for sale to U.S. customers. 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 Hangsen Red Energy 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 investigation revealed that a minor ordered "Hangsen RedBull e-liquid" but received "Hangsen Red Energy e-liquid."

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