FDA WARNING_LETTER - Vapetrunk Company Inc - January 21, 2020
Discuss this record with AI
The FDA's Center for Tobacco Products issued a Warning Letter to Reeta Dubois of Vapetrunkcompany.com on December 12, 2019, following a review of their website. The FDA determined that the e-liquid products advertised and sold to U.S. customers are tobacco products under section 201(rr) of the FD&C Act.
The primary violation identified is that several e-liquid products, including Dinner Lady Berry Blast, Illusions The Prophet, Illusions Spellbound, Dinner Lady Purple Rain, and Dinner Lady Melon Twist, are misbranded under section 903(a)(7)(B) of the FD&C Act. This is because their website advertising fails to include the required nicotine warning statement: "WARNING: This product contains nicotine. Nicotine is an addictive chemical," as mandated by 21 C.F.R. § 1143.3(b). This regulation applies to advertising for covered tobacco products like e-liquids.
The letter requires immediate correction of this violation and similar issues across all advertising platforms. Failure to comply may result in 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 advertising/sales, and a plan for ongoing compliance.
ID · 241df4a7-d52c-42ab-96c4-7390031c5bdd
Full citation text and observation details available on the Dashboard.