Recent FDA Enforcement Letters Signal Increased FDA Scrutiny of Hemp Products
By Catie Wightman, Michelle Bodian
Nov 30, 2022
On November 21, 2022, the FDA issued five warning letters to companies selling CBD, Delta-8, and other hemp products for humans and pets. These letters are notable for the following five reasons (see additional details below):
Warning letters were issued to hemp companies selling products that "people may confuse for traditional foods or beverages,” with an emphasis on products that could be appealing to children
Warning letters addressed products containing cannabinoids other than CBD, including Delta-8 THC, CBG, and CBN
Warning letters were issued for pet products containing CBD
The FDA sampled and tested products to confirm that CBD content matched the product label
FDA cited Facebook posts from several years ago that contained prohibited claims
Traditional Food Products Containing CBD
While these most recent warning letters do address prohibited claims (e.g., claims a product can diagnose, cure, mitigate, treat, or prevent disease) made about the products, the emphasis on traditional food products containing CBD or other cannabinoids is not something the FDA has focused on in the past. In an update announcing the recent batch of letters, the FDA stated that it is concerned that products containing CBD could be confused with traditional foods or beverages which “may result in unintentional consumption or overconsumption of CBD.” Products addressed in the warning letters include teas, lollipops, infused sugar, gummies, coffee, cookies, fruit snacks, and gum. The agency explained that it is particularly concerned with products that are appealing to children, citing gummies, hard candies, and cookies as examples.
Products Containing Delta-8 THC, CBG, and CBN
One warning letter addressed products containing CBG and CBN, cannabinoids that have not seen much enforcement from FDA in the past. This letter explained that claims about these products render them unapproved new drugs, and selling such products violates the Federal Food, Drug, and Cosmetic Act (FFDCA). In addition, another warning letter stated that products containing Delta-8 THC are adulterated under the FFDCA because there is no indication that it is Generally Recognized as Safe (GRAS).
This batch of warning letters also noted that pet products containing CBD marketed for intended uses, including separation anxiety, noise aversion, and seizures, are adulterated and unsafe under the FFDCA. This is an important reminder that pet products are not exempt from FDA regulation.
In this round of warning letters, FDA noted that they have sampled and tested the products in question to compare the amount of CBD on the label to the amount of CBD in the product. One of the warning letters also noted that a lollipop product did not have a label indicating that it contained CBD, while testing completed by the FDA confirmed that the product did contain CBD. The FDA was concerned that this mislabeled product created a risk that children could mistake the product for a traditional lollipop. This activity is much more involved than the FDA’s previous approach, which typically included reviewing labeling and marketing materials for prohibited claims.
Prohibited Claims in Past Facebook Posts
Under the FFDCA, products not approved as drugs by the FDA are prohibited from claiming they can diagnose, cure, treat, mitigate, or prevent a disease in humans or animals. These claims are prohibited from being included on product labels and any associated marketing materials, including websites and social media. In this most recent batch of warning letters, the FDA cited two Facebook posts from 2017 containing prohibited claims, indicating that even posts from many years ago can still put companies at risk. This round of letters shows that FDA is still concerned with prohibited claims, even those from years in the past, and it may also be expanding its enforcement priorities for hemp products beyond drug or disease claims.
With a new year approaching, all eyes will be on the FDA to determine whether the agency is stepping up enforcement against CBD products and/or revising its enforcement priorities. To mitigate enforcement risks, hemp product companies should ensure that their products are properly labeled and are not appealing to children.