eCigarettes Canada – FDA Warning Letter, Sep 27, 2019

On September 27, 2019, the FDA's Center for Tobacco Products issued a Warning Letter to ecigarettescanada.com after reviewing their website and determining that e-liquid products were advertised and offered for sale to U.S. customers. These e-liquids are classified as tobacco products under section 201(rr) of the FD&C Act.

The primary violation identified is that several e-liquid products, including "Banana Cream," "Blueberry," and "Watermelon," are misbranded under section 903(a)(7)(B) of the FD&C Act (21 U.S.C. § 387c(a)(7)(B)). 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).

The FDA requires immediate correction of this violation and similar issues to ensure compliance with the FD&C Act and its implementing regulations. Failure to comply may result in further 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 subject to detention and refusal.

A written response detailing corrective actions, including dates of discontinued violative activities and