The passage of the Agricultural Improvement Act of 2018 (commonly known as the “Farm Bill”) has been a boon for hemp and cannabidiol, or CBD oil. However, as members of the hemp industry are well aware, the 2018 Farm Bill and USDA’s Interim Final Rule establishing the U.S. Domestic Hemp Production Program came far from answering all questions surrounding the legality of growing, processing, transporting, and selling hemp and hemp products in the United States. Critically, while USDA’s Interim Final Rule provide hemp farmers with guidance on how to lawfully cultivate hemp, the USDA cannot regulate beyond its authority, which is limited to the production and processing of hemp.
The consumption of hemp and CBD products is under the jurisdiction of the Food and Drug Administration (the “FDA”). The FDA is responsible for regulating all supplements in food, drugs, and cosmetics under the Federal Food, Drug, and Cosmetic Act (FFDCA). Notably, the FDA has not approved CBD as “Generally Recognized As Safe” (“GRAS”) for use in human or animal food*. This means that it is currently illegal to market CBD by adding it to a food, as a drug, or to label it as a dietary supplement.
For organic certifiers tasked with determining whether a particular product qualifies as “organic” under USDA guidelines, the relationship between CBD and organic has become particularly fraught. The USDA has developed instructions on how to certify industrial hemp products, which include CBD, as organic. However, under the FDA’s regulations, CBD cannot be added to food even if hemp derived. This poses a challenge for organic certifiers: can they be held liable for CBD that they have certified as organic, which a third party later adds to a food product or dietary supplement?
For now, if organics certifiers are asked to certify CBD food or dietary supplement products as organic, the safest course is to wait until the FDA has provided clear guidance on how CBD can or cannot be used in food products. Currently, only hulled hemp seed (GRN765), hemp seed protein powder (GRN771), and hemp seed oil (GRN778) have been approved as GRAS by the FDA. The FDA has prohibited under section 301(ll) of the FFDCA the introduction into interstate commerce of any food to which CBD or THC has been added. Organic or not, CBD and THC cannot currently be added to food products, and organic certifiers and other industry partners should heed caution when handling and marketing organic CBD products.
*While the FDA did issue three “Generally Recognized As Safe” notices for hemp seed derived food ingredients, the agency made to clear that these notices only approved of products containing “trace amounts of THC and CBD, which the seeds may pick up during harvesting and processing when they are in contact with other parts of the plant.” Further, the FDA stated that “[t]hese GRAS conclusions do not affect the FDA’s position on the addition of CBD and THC to food. As stated on FDA and Marijuana: Questions and Answers, it is a prohibited act under section 301(ll) of the Federal Food, Drug, and Cosmetic Act to introduce into interstate commerce a food to which CBD or THC has been added.”