On January 2, the Food and Drug Administration (“FDA”) issued non-binding guidance (“Guidance”) in which the agency explains how it intends to prioritize enforcement actions to tackle the growing increase in youth use of electronic nicotine delivery systems (“ENDS”)–more commonly and broadly referred to as “e-cigarettes”–as well as to address vaping-associated lung injuries. According to a press release by the U.S. Department of Health and Human Services, the FDA intends to ban flavored cartridge-based ENDS that appeal to children, including fruit and mint flavors, beginning 30 days from the publication of the notice of availability of this guidance in the Federal Register.
Specifically, the agency intends to prioritize enforcement against:
- Any flavored, cartridge-based ENDS product (other than a tobacco- or menthol-flavored ENDS product);
- All other ENDS products for which the manufacturer has failed to take (or is failing to take) adequate measures to prevent minors’ access; and
- Any ENDS product that is targeted to minors or whose marketing is likely to promote use of ENDS by minors.
Since the enactment of the 2018 Farm Bill, a wide range of hemp-derived CBD (“Hemp CBD”) products have sparked the interest of American consumers, including CBD vaping devices. Despite the growing popularity of CBD smokable products, the FDA has yet to issue regulations for these products. Consequently, the sale of Hemp-CBD-infused smokable products is in a legal gray area, not explicitly allowed nor prohibited under federal law.
The lack of FDA regulation surrounding this issue likely stems from the fact that many of these products are free of tobacco and/or nicotine.
As we previously discussed, federal law gives the agency the authority to regulate the sale, manufacture, and marketing of tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act (“TCA”). In 2016, the FDA finalized a rule that extended its regulatory authority to all products meeting the TCA’s statutory definition of a tobacco product, including e-cigarettes.
The FDA now oversees all products “made or derived from tobacco that [are] intended for human consumption . . . .” The definition also includes components, parts, and accessories of tobacco products and excludes products that are classified as drugs or devices under the Food, Drug, and Cosmetic Act (“FDCA”), even if those products are made or derived from tobacco.
The FDA has consistently declined to interpret “tobacco products” so broadly as to include products free of nicotine or tobacco. Under this reasoning, it seems to follow that most Hemp-CBD smokable products, which are free of nicotine and tobacco, would not be considered “tobacco products.”
The newly published Guidance seems consistent with this rationale.
The Guidance expressly provides that it “does not address products that are not tobacco products” and that only “[l]iquids that do not contain nicotine or other material or derived from tobacco, but that are intended or reasonably expected to be used with or for the human consumption of a tobacco product, may be components or parts and, therefore, subject to FDA’s tobacco control authorities.” (Emphasis added).
So, while most Hemp-CBD-infused vaping devices don’t fall under the FDA’s jurisdiction, and thus, won’t be affected by this upcoming enforcement effort, industry players should keep in mind that:
- Any flavored CBD vaping product that does contain nicotine is subject to this federal ban;
- Any CBD vaping product that contains nicotine and for which the manufacturer fails to take adequate measures to limit minors’ access is subject to FDA enforcement actions;
- Any CBD vaping product that is targeted at minors or whose marketing is likely to promote the ENDS use by minors falls under the FDA ban; and
- The manufacture, sale and marketing of non-flavored, nicotine or tobacco-free CBD vaping products, as well as other smokable hemp products, may nonetheless be banned under certain state laws. Accordingly, manufacturers, distributors and retailers of these products should refrain from selling their products in these jurisdictions to mitigate the risk of local enforcement actions.