CBD is absolutely booming. The non-intoxicating cannabinoid (drug present in cannabis), which offers a calming counterpart to mind-altering THC, is behind the wave of enthusiasm for cannabis that goes well beyond the states in which adult-use cannabis is legal. As of December, when updates to the Farm Bill legalized hemp-derived CBD, consumers have been clamoring for the product many believe is a cure-all for conditions that range well beyond just those it has been clinically proven to soothe, like MS, epilepsy, and other ailments that cause muscle spasticity. Many Americans believe CBD provides effective relief from anxiety and insomnia, pain and inflammation, colitis, and blood pressure, and they want to get as much of it as they can.
The natural consequence of this enthusiasm has been the rise of CBD as a food ingredient, but unlike other trendy “superfoods,” it is only just beginning to emerge from the shadow of cannabis prohibition, and continues to present a legal challenge for those chefs and food producers hoping to add it to their products. In New York, for example, the city intends to fine those adding CBD to food. This has left food producers hoping to profit from the CBD boom in a tough spot.
Anna Wiand, senior associate at Florida law firm Gray Robinson, says that while the 2018 Farm Bill legalized industrial hemp, the FDA “retains authority over FDA-regulated products that contain hemp or hemp derivatives, like CBD. Thus FDA retains federal regulatory authority over CBD as a food additive. In a December 2018 press release the FDA advised that it will continue to treat products containing CBD the same way the Agency treats any other FDA-regulated products. [Products] containing CBD remain subject to the same authorities and requirements as FDA-regulated products containing any other substance.”
The FDA’s current position, says Wiand, is that it’s unlawful under the Food, Drug, and Cosmetic Act (FD&C) to allow any food containing CBD or THC to be trafficked interstate or to market them as dietary supplements—even if the CBD is hemp-derived.
The reason is that both CBD and THC are active ingredients in FDA-approved drugs, and thus “were the subject of substantial clinical investigations before they were marketed as foods or dietary supplements. Under the FD&C Act, it’s illegal to introduce drug ingredients like these into the food supply, or to market them as dietary supplements. This is a requirement that we apply across the board to food products that contain substances that are active ingredients in any drug.”
The present approach may not be the same forever, Wiand notes. The enormous popularity in CBD has not gone unnoticed, and this has increased pressure on Congress. In turn, Congress will soon begin rule-making to develop industry guidance about how to add CBD to FDA-regulated products like food.
This is not the same set of rules as applies to hulled hemp seeds, hemp-seed protein, and hemp-seed oil. These are considered “Generally Recognized as Safe” and can be marketed in food without any need for additional approval, so long as they don’t make any claims the ingredients treat disease.
However, it’s CBD that consumers are excited about, not just hemp, and food is a helpful delivery system as it slows CBD metabolization in such a way as to prolong its effects—whatever these may actually be.
Wiand notes, after all, that “preliminary studies conducted on the effectiveness of CBD use dosages that far exceed those found in the standard CBD latte or CBD cookie. Little is known apart from anecdotal reports about the effectiveness of doses at these lower levels.”
The industry is already pushing back hard against regulations limiting the use of CBD as a food additive because consumers are so enthusiastic about it. Even the New York State ban makes allowance for using it as a dietary supplement, Wiand says, “as long as the CBD and CBD products are manufactured pursuant to FDA dietary supplement standards and labeled and marketed as a dietary supplement. This includes adherence to the FDA Good Manufacturing Practices standards for dietary supplements. Until the FDA takes a position on the use of CBD as a food additive, the state and local statutes and regulations will [be in] control.”
Food producers will likely continue manufacturing CBD products to meet the prodigious demand, and Wiand counsels them above all to “ensure their products do not enter interstate commerce. Additionally, as noted, some state and local governments have taken the position that CBD infused foods are not allowed, and other states that have recently passed comprehensive medical marijuana laws now regulate CBD under those laws and regulations. Accordingly, a food producer or processor should first confirm the legality of using CBD as a food additive in their particular jurisdiction.”
Wiand adds that producers must take care not to make claims about the products that contradict federal and state laws.
“In the past,” she says, “FDA has issued warning letters to companies marketing products that contain CBD with claims that the products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. As a general matter, given the regulatory uncertainty surrounding using CBD as a food additive, a food producer/processor should confer with knowledgeable legal counsel to confirm the specific regulatory requirements governing that producer/processor.”