Vapor Alley – FDA Warning Letter

The FDA's Center for Tobacco Products issued a Warning Letter to Richard Mulder of Vapor Alley (vaporalley.com) after reviewing their website and determining that e-liquid products were offered for sale in the U.S. The Milkman Pudding e-liquid was identified as a tobacco product under section 201(rr) of the FD&C Act.

The primary violation cited was the sale of The Milkman Pudding 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 (21 U.S.C. § 387c(a)(7)(B)). This violates 21 C.F.R. § 1140.14(b), which prohibits retailers from selling covered tobacco products, including e-liquids, to minors.

Vapor Alley is required to immediately correct this violation and any similar ones, ensuring all tobacco products and related advertising comply with the FD&C Act and FDA regulations. Failure to comply may result in further FDA action, including civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates of violative sales/advertising and a plan for maintaining compliance, must be submitted within 15 working days.