The U.S Food and Drug Administration (FDA) will hold its first public hearing Friday (May 31st) on how to best regulate CBD products. The FDA is seeking information about cannabis-based compounds, as well as scientific data to gain further insight into the production and sale of cannabis products.
Hemp derived CBD was made legal with the passage of the 2018 Farm Bill, but the FDA has avoided taking a stance on CBD, choosing to only bar the use of unreasonable claims. The FDA has issued a number of warning letters to CBD companies for making a number of non-FDA approved claims about the benefits of CBD.
FDA Commissioner Scott Gottlieb, M.D., provided further clarification on the warning letters, as a April press release indicated they were sent to the companies “in response to their making unsubstantiated claims related to more than a dozen different products and spanning multiple product webpages, online stores and social media websites. The companies used these online platforms to make unfounded, egregious claims about their products' ability to limit, treat or cure cancer, neurodegenerative conditions, autoimmune diseases, opioid use disorder, and other serious diseases, without sufficient evidence and the legally required FDA approval.”
The FDA has worked to limit egregious claims thus far, but it may need to do more as the CBD market continues to boom, considering some of the biggest hurdles this industry is facing relate back to regulatory issues at a federal level, including banking, taxation, consumer protection, and labeling. Friday’s hearing will hopefully begin gathering this information to produce regulatory guidelines in the future.
Cannabidol, which CBD is short for has enjoyed quite the surge since it was legalized in 2018. With its many touted benefits, this non-intoxicating form derivative of cannabis is being gobbled up by companies like CVS.
CVS now sells a line of CBD topical products, including creams and lotions. Other large brands including Designer Brands (formerly DSW) and Urban outfitters are not far behind, both of which are undergoing testing topical CBD products in their stores.
However, CBD has not yet been approved by the FDA for food and drinks – which many suspect will be a topic of conversation at the Friday hearing. Hundreds of companies have begun including CBD in their food, from a cupcake restaurant near our office in Tampa, to Carl Jr’s 4/20 CBD burger.
With thousands of companies struggling to gain control over the market, the current legal framework for CBD has grown increasingly hazy. In an interview with Bloomberg, Attorney Robert DiPisa put it best “As an attorney, I try to read everything that the FDA is putting out, I try to gather as much information as possible to guide them in the best direction I can, but the truth of the matter is everyone is running blind right now.”
With the CBD industry estimated to be worth nearly $22 billion by 2022, as well as an unclear legal framework for expansion the pressure is on the FDA to act quickly.
However, the FDA has expressed concern that allowing the substance in food, beverages, and supplements. In his aforementioned memo, Gottlieb mentions that there remain “open questions about whether some threshold level of CBD could be allowed in foods without undermining the drug approval process or diminishing commercial incentives for further clinical study of the relevant drug substance.”
This makes it increasingly likely that the FDA will attempt to limit the amount of CBD that can be put into food or drink, according to Robert DiPisa. He went on to say that he believes the FDA will reserve the higher dosages of CBD for traditional pharmaceutical drugs, while using the lower doses for food and drinks. DiPisa thinks that this will both allow operation of third-party companies, while maintaining an avenue for research and profit for large pharmaceutical corporations.
It’s becoming increasingly clear that the best avenue for consistent CBD growth is through regulation. The main challenge to CBD is there’s not a consistent, federally accepted process to produce a pure product. By regulating it, the FDA can lay out a standard which companies can get stabilized and then have hard numbers which to attack with.
By having the rules in place, the FDA can attack outliers who make egregious claims as opposed to letting them run wild and endanger the consumer, DiPisa said.
The hearing will be held at the FDA headquarters in Silver Spring, MD. Electronic or written comments will be accepted until July 2nd. We will continue to update this article as more information regarding the hearing is made public.