In a recent interview with the Wall Street Journal, the FDA has signaled it may be poised to finally act on hemp-derived substances in food products. If FDA does take action, this could mean a newly regulated market for CBD food products.
Currently, FDA has determined it is a prohibited act to introduce or deliver for introduction into interstate commerce any food (including any animal food or feed) to which THC or CBD has been added. This is in part due to Epidiolex, a seizure medication containing CBD. FDA regulations state that if a substance (such as THC or CBD) is an active ingredient in a drug product, that ingredient cannot be introduced as a dietary supplement or food product. FDA has regularly issued warning letters to companies marketing and selling consumable CBD products. Under current FDA regulations, the only hemp food products allowed on the market having earned Generally Recognized as Safe (GRAS) status are hulled hemp seed, hemp seed protein powder, and hemp seed oil.
Though FDA has regulations in place to approve new dietary ingredients, agency officials seem uncertain about how hemp product regulations may function in the future and have hinted at needing Congressional action to approve products: “Given what we know about the safety of CBD so far, it raises concerns for FDA about whether these existing regulatory pathways for food and dietary supplements are appropriate for this substance,” said FDA Principal Deputy Commissioner Janet Woodcock, who has led the agency’s efforts looking at cannabis regulation.
What has caused the FDA’s delay in moving forward with regulations, especially in light of the numerous products on the market? The WSJ quotes that perhaps the recent rise of “intoxicating hemp-derived products” has caused confusion in the issuance of regulations. Agency representatives were quoted saying:
the agency had “growing and more intensifying short-term concerns” about intoxicating hemp-derived products….“Over the last year and a half, we have seen a whole host and cadre of intoxicating hemp-derived cannabinoids come up…There are very, very different regulatory considerations for products that are going to intoxicate you.”
Despite the awareness of the “widely unregulated market,” the agency is still hammering out the details; “I don’t think that we can have the perfect be the enemy of the good when we’re looking at such a vast market that is so available and utilized,” said Norman Birenbaum, a senior adviser in the agency working on the issue.
It also appears that FDA will emphasize consumer protection and awareness of CBD use if products are eventually approved; agency representatives said “The safety profiles around these products are not what they are generally accustomed to and not the same as what they get from other products when they walk into a wellness store or grocery store or even a gas station.” In particular, the agency is analyzing “whether CBD can be safely eaten every day for a long period or during pregnancy, for example. He pointed to concerns about future fertility.”
State regulations may offer a glimpse into how FDA could regulate CBD food products. Texas offers consumable hemp licenses for “any product processed or manufactured for consumption that contains hemp, including food, a drug, a device and a cosmetic,” including the addition of CBD into food products. Similarly, Connecticut, under its Consumer Protection Division, has a pilot licensing program for manufacturers interested in marketing and selling consumable hemp products containing CBD. In the historic Assembly Bill 45, California took steps to incorporate hemp products into its robust cannabis supply chain through consumable food and dietary supplements. In Oregon, starting January 1, 2023 anyone operating in the hemp cannabinoid supply chain is now required to obtain a Hemp Handler license, and must meet all product testing and potency requirements prior to sales to consumers.
Where does this leave members of the industry? Still at a standstill unfortunately until FDA officially acts and announces a plan of action. The industry (and the agency) is hopeful to see movement within the next few months, and US Hemp Roundtable announced they plan to meet with the FDA within the coming weeks to discuss “continuing dialogue on what a regulatory scheme should entail” as well as meet with Congressional members.
Have further questions about federal or state regulations on CBD and hemp products? Are you worried about receiving an FDA warning letter? Please schedule a consultation with EARTH Law, LLC to answer any questions regarding these updates, or for help with your 2023 license applications. You can contact us by email at firstname.lastname@example.org or by telephone at 541-632-3946.