Earlier this year, the Food and Drug Administration (“FDA”) began seizing various cannabidiol (“CBD”) products from store shelves. These enforcement actions reflected the implementation of the agency’s position that CBD, regardless of the source from which it is derived, cannot be lawfully sold for human consumption.
A few states, including states that have adopted industrial hemp pilot research programs under the 2014 Farm Bill, now seem to have embraced this FDA position by banning certain CBD-infused products from local stores.
Last Friday, several New York restaurants, bakeries, and bars were forced to stop selling CBD-infused foods and drinks. Officials with the New York City Department of Health confiscated those products, marking them as “embargoed.” The embargo process consists of identifying, itemizing and removing products. The Department has yet to issue a public statement or to provide further information on these actions, but it appears state health inspectors explained to the business owners that CBD cannot be used as a “food additive”.
This argument was similar to that used by the Maine Department of Health and Human Services (“DHHS”). Earlier last week, Maine health authorities notified various businesses that they needed to remove all CBD-infused foods, tinctures, and capsules from their shelves. Relying on an internal report by the state Maine Attorney General’s Office which concluded that CBD could not be used in mass-market food until Maine’s hemp pilot program receives federal approval pursuant to the 2018 Farm Bill, the Maine DHHS determined that CBD was an unapproved food additive the FDA does not recognize as safe.
Section 201(s) of the Food, Drug, and Cosmetic Act (“FD&C Act”) defines “food additive” to encompass any substance that may reasonably be expected to directly or indirectly affect or become part of a food. Until a food additive is tested and found safe for its intended use, it is deemed unsafe. A food additive is considered safe if there is a reasonable certainty that it is not harmful under its intended use and condition. If a food additive is added to a food prior to FDA approval, its presence renders the food adulterated and subject to enforcement action.
Because the FDA has yet to approve CBD as a food additive, Hemp-CBD products, particularly edibles and infused drinks are deemed unsafe under the FD&C Act.
Though state health authorities embargoed CBD edibles and other CBD products used for human consumption, they told affected business owners they could continue selling CBD products that “could be smoked, vaped, worn as a patch or applied as lotion.” This is because cosmetics and smokable products are subject to less onerous FDA regulations than foods and dietary supplements. This all may change when the FDA soon releases its plan to regulate Hemp-CBD products.
These recent enforcement actions in New York and Maine should remind industry players that business and legal considerations surrounding Hemp-CBD products are in a constant state of flux.