California is essentially letting the FDA dictate what it will do with hemp CBD.
Earlier this month, the California Department of Public Health’s Food and Drug Branch (CDPH-FDB) issued a revised FAQ on cannabidiol (CBD) in food products. Per these FAQs it appears California intends to block the sale of hemp-derived CBD products — which are pretty much already everywhere in California, including juice bars, yoga studios, and even beer breweries.
CDPH-FDB has determined that CBD sourced from industrial hemp cannot be added to food (including drinks) for either humans or pets:
[A]lthough California currently allows the manufacturing and sales of cannabis products (including edibles), the use of industrial hemp as the source of CBD to be added to food products is prohibited. Until the FDA rules that industrial hemp-derived CBD oil and CBD products can be used as a food or California makes a determination that they are safe to use for human and animal consumption, CBD products are not an approved food, food ingredient, food additive, or dietary supplement.
California’s Health and Safety Code defines “food” as “a raw, cooked, or processed edible substance, ice, beverage, an ingredient used or intended for use or for sale in whole or in part for human consumption, and chewing gum.” CDPH-FDB’s FAQ makes clear that the following will not be allowed in food:
- Any CBD products derived from cannabis
- Any CBD products, including CBD oil derived from industrial hemp
- Hemp oil not derived from industrial hemp seeds
- Industrial hemp seed oil enhanced with CBD or other cannabinoids
Seeds derived from industrial hemp and oil made from industrial hemp seeds are allowed in food if the distributor of those items makes no medical claims about the seeds or the oil.
CDPH-FDB also distinguishes between “hemp seed oil” and CBD oil:
“Industrial hemp seed oil and hemp-derived CBD oil are two different products. Industrial hemp seed oil is derived from the seeds limited to types of the Cannabis sativa L. plant and may contain trace amounts of CBD (naturally occurring) and other cannabinoids. Food grade Industrial hemp seed oil is available from a variety of approved sources.”
However, CBD or CBD oil derived from industrial hemp is NOT approved for human and animal consumption by the FDA as food and therefore cannot be used as a food ingredient, food additive, or dietary supplement. CDPH-FDB confirmed in its FAQs that “there is no regulatory agency that provides oversight for the production of CBD oil from industrial hemp,” but CDPH does have authority over food and dietary use products generally and, therefore, food products containing CBD oil are within its authority to regulate. The FAQ also adds that “CBD is an unapproved food additive and NOT allowed for use in human and animal foods in California regardless of where the CBD products originate.” So, no out-of-state hemp-CBD loophole.
CDPH-FDB distinguished cannabis edibles sold under MAUCRSA and regulated by CDPH’s Manufactured Cannabis Safety Branch from non-cannabis food products sold outside that regulatory framework. Yet in another blow to hemp-CBD, the Bureau of Cannabis Control will not allow MAUCRSA-licensed retailers to sell standalone hemp-CBD products even though BCC rules explicitly allow for selling non-cannabis products at licensed retail storefronts.
The FAQs also address the Food and Drug Administration (FDA), which has a complicated relationship with CBD. The FDA states in its own THC/CBD FAQs that it is prohibited 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.” The FDA has also sent out cease and desist letters (see here, here, and here) to CBD producers and sellers that made medical claims about their CBD products in violation of the Federal Food, Drug & Cosmetic Act. The FDA takes the position that CBD is neither a conventional food nor a supplement exempt from drug testing.
Recently though, the FDA approved Epidiolex, a cannabis-based drug that treats severe forms of epilepsy. This approval does not mean the FDA now allows for all CBD products or that it will now allow businesses to make medical claims about CBD for products that have not been approved as drugs under the Federal Food Drug & Cosmetic Act — in other words, anything containing CBD that is not Epidiolex. Essentially, California is letting the FDA dictate what it will do with hemp CBD. Though many other states allow hemp CBD for human consumption pursuant to Federal Farm Bill programs, California is choosing to follow in near lock-step with Big Brother on this one. How exactly CDPH-FDB plans to enforce its FAQ is not clear given that hemp CBD products are already rampant in California.
Our California CBD lawyers will continue monitoring this evolving situation as hemp CBD makers and sellers struggle to navigate and comply with California’s ultra-strict hemp CBD rules. And for those interested in learning more about the ins and outs of CBD laws, please check out this upcoming webinar on August 16th.