FDA is continuing the crackdown on the sale of tobacco products to minors (see our post here regarding recent FDA actions). On May 1, 2018, FDA and FTC issued 13 joint warning letters to manufacturers, distributors, and retailers for misleadingly labeling or advertising nicotine-containing e-liquids as kid-friendly food products, such as juice boxes, candies, and cookies.
The Federal Food, Drug, and Cosmetic Act (FDCA) provides that a tobacco product shall be deemed misbranded if, in relevant part:
1) its labeling is false or misleading (section 903(a)(1)), or
2) if, in the case of any tobacco product distributed or offered for sale in any State, its advertising is false or misleading in any particular (section 903(a)(7)(A)) or it is sold or distributed in violation of certain regulations, such as regulations prohibiting sale to minors (section 903(a)(7)(B)).
Section 201(rr)(4) of the FDCA prohibits a tobacco product from being marketed in combination with any other article or product regulated under the FDCA (including a drug, biologic, food, cosmetic, medical device, or a dietary supplement).
In terms of FTC authority, Section 5 of the FTC Act prohibits unfair or deceptive acts or practices in or affecting commerce. This prohibition includes practices that present unwarranted health or safety risks.
FDA and FTC found that companies violated the provisions outlined above by using false or misleading labeling and/or advertising that cause e-liquids to imitate food products, particularly ones that are marketed toward and appeal to minors. The batch of 13 warning letters all cited violations to both misbranding violations (under section 903(a)(1) of the FDCA) and unfair or deceptive acts or practices (Section 5 of the FTC Act). In addition, 6 warning letters also cited a violation of section 903(a)(7)(B) of the FDCA for sale of e-liquid products to minors and 1 warning letter cited a violation of section 201(rr)(4) of the FDCA for marketing a tobacco product in combination with a food product.
The warning letters mention that children are at particular risk for ingesting e-liquid products when the products have labeling and/or advertising that cause the product to imitate food products typically marketed toward and appealing to children. The warning letters also make the point that children are at particular risk because exposure to nicotine in the e-liquid can result in acute toxicity and, further, that severe harm can occur, including seizure, coma, respiratory arrest, and death from cardiac arrest.
The issuance of this batch of warning letters is just the most recent part of FDA’s ongoing efforts to enforce regulations specifically aimed at addressing youth access to tobacco products. We anticipate more FDA actions in the future and will continue to provide updates.