FDA and FTC jointly crack down on Internet distributors of Delta-8 THC cannabis edibles, citing particular concern about appeal to children
FDA and FTC have issued a series of six warning letters targeting online distributors of edibles with Delta-8 tetrahydrocannabinol (THC) that mimic conventional foods like chips, cookies, candy, gummies, and other snack items.
In these letters, FDA expresses continued concern about the proliferation of products containing Delta-8 THC – the agency has been warning about this substance for some time now. FDA cites its unease with products that can be mistaken for conventional foods and consumed unknowingly, particularly by children, as well as its concern about ingestion in higher doses than intended. Many of the products cited in these letters mimic well-known snack food brands by using similar packaging, names, and pictures. Because Delta-8 THC is not approved for use in food and is not generally recognized as safe (GRAS), FDA says these products are adulterated under section 402(a)(2)(C)(i) of the Federal Food Drug and Cosmetic Act.
FTC joined in warning these companies, citing Section 5 of the Federal Trade Commission Act, which prohibits unfair or deceptive acts or practices, including practices that present unwarranted health or safety risks. FTC shares FDA’s concern that these Delta-8 THC products have an appearance and form similar to conventional foods and candies often consumed by children, often imitating well-known brands. Children, FTC notes, are at particular risk for ingesting these edibles unknowingly.
Targeting retail websites
The agencies jointly issued these letters to an array of companies: Delta Munchies, Dr. Smoke LLC (also known as Dr. S LLC), Exclusive Hemp Farms/Oshipt, Nikte’s Wholesale LLC, North Carolina Hemp Exchange LLC and The Haunted Vapor Room. These letters indicate that Delta-8 THC is a priority area for enforcement since these companies sell many other cannabis products that seem to violate federal laws. As with all FDA warning letters, the agency states that the letters are “not intended to be an all-inclusive statement of violations that may exist in connection with your products.”
These letters are also significant in that they continue an agency trend of holding retailers responsible for the products they sell, since many of the targeted companies are not the manufacturers of the products. Given the large number of companies that are producing cannabis edibles and the number of US states have legalized these products, it has grown even more difficult for federal agencies to regulate this rapidly growing marketplace. Furthermore, taking action against individual companies may feel like a game of “whack-a-mole” – since such companies often rename themselves and continue to distribute the same products. Websites not only provide an interstate commerce hook for the agencies, but also make it easier to stop the sale of multiple products at once.
In addition, these letters may capture the attention of Congress, which is already contemplating legislation in the cannabis area, particularly after FDA’s announcement that it is seeking additional authorities to regulate cannabidiol (CBD) products. It seems unlikely that any legislation will be limited to CBD, given the safety risks and regulatory ambiguity around other cannabinoids, such as Delta-8 THC.
Find out more about these developments by contacting the author or any member of our Cannabis, Hemp and CBD team.
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