FDA WARNING_LETTER - Safe Way Ecig, Inc.

The FDA Center for Tobacco Products issued a Warning Letter to Mark Ratkevich of safewayecig.com after reviewing their website and determining that e-liquid products, specifically "Peanut e-liquid," were offered for sale and distribution in the U.S. These products are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified was the sale of "Peanut 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.

The FDA requires immediate correction of this violation and similar issues, ensuring all tobacco products, labeling, and advertising comply with the FD&C Act and FDA regulations across all sales channels. Failure to comply may result in civil money penalties, no-tobacco-sale orders, criminal prosecution, seizure, and/or injunction. A written response detailing corrective actions, including discontinuation dates and a compliance plan, is required within 15 working days.