On May 1, 2018 the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) issued 13 warning letters to companies that they claim misleadingly labeled or advertised nicotine-containing e-liquids as kid-friendly food products such as juice boxes, candies, and cookies.  Warning letters were issued to manufacturers, distributors, and retailers of eight products.

All warning letters included allegations of violations of Sections 902(a)(1) and 902(a)(7) of the Food, Drug, and Cosmetic Act (FDCA) – both of which relate to labeling or advertising that is misleading or untrue in any particular – and Section 5 of the FTC Act for unfair or deceptive advertising.  Both the FDA and FTC alleged violations are based on the risk of confusion, especially by children, between the e-liquid products and foods that are marketed toward, or appealing to, children.

In some of the warning letters issued to distributors and retailers, FDA added allegations that the e-liquids were sold to minors in violation of Section 903(a)(7)(B) of the FDCA.  In one instance, FDA alleged that the company violated Section 201(rr)(4) of the FDCA – which bars the marketing of a tobacco product “in combination with any other article or product regulated” by FDA – because a combination pack of candy and e-liquid were offered together.  The warning letters also highlighted the potential harm that could result if nicotine-containing e-liquids are ingested by children, although the number of poison center calls regarding e-liquids has fallen dramatically since the Children’s Nicotine Poisoning Prevention Act went into effect in 2016.  That law requires “liquid nicotine containers” use child-resistant packaging just like prescription drugs, some over-the-counter (OTC) drugs, and other potentially hazardous products found in the home, pursuant to the Poison Packaging Prevention Act.

The issuance of the 13 warning letters comes about a week after FDA Commissioner Gottlieb announced that FDA (1) recently issued warning letters to 40 retailers for underage sales of JUUL products, (2) was in the midst of a “new blitz of retail establishments targeting youth sale violations”, (3) is seeking to end sale of JUUL products to minors, and (4) would examine the youth appeal of JUUL products.  FDA also requested JUUL Labs submit information regarding, among other things, its marketing, research studies, and how certain product features might appeal to different age groups.  While some have argued that the panic over JUUL, which appears to be based on anecdotal evidence and media reports, could actually adversely impact the public health, there is no doubt that FDA is committed to cracking down on underage sales and reducing youth appeal of tobacco products, including vapor products.

In light of the warning letters issued on April 24 and May 1 and the Agency’s interest in tobacco product flavors, it appears that FDA may be setting its sights on the elimination of flavored e-liquids, which have also been shown to help adult smokers transition to less harmful vaping alternatives, as part of its effort to curb the use of vapor products by youth. Of note, a recent study evaluating how young people use vapor products in the United Kingdom, where the products are actively promoted by the government as less harmful than cigarettes and as a way to quit smoking, found that most product experimentation does not turn into regular use, and that regular use of vapor products in young people who have never smoked remains very low.

Industry and other stakeholders interested in maintaining the availability in the U.S. of flavored e-liquids have until June 19, 2018 to submit comments to FDA’s Advanced Notice of Proposed Rulemaking.