For more than a year, one question in particular has been a priority for the cannabis industry: how will the US Food and Drug Administration regulate CBD?
Ever since the 2018 Farm Bill legalized hemp, catalyzing the spread of already popular hemp-derived CBD products, companies hoping to sell these products—including some mainstream names—have played a game of stop-and-go, trying to prepare for consumer demand while staying within regulatory boundaries.
And while the FDA has collected public input, held meetings, and made small announcements along the way, no decisions have yet been made.
This week, some insight into the FDA process has arrived, but still no answers. An appropriations bill enacted in December required the FDA to, within sixty days, provide Congress with a report detailing steps taken toward determining data-driven regulatory and enforcement approaches when it comes to CBD products.
That report has landed. (Read it in full here.) It includes, among other updates, a breakdown of the FDA’s efforts by product type, considering the widespread interest in including CBD in a variety of products, from cosmetics to food. This includes even animal feed, as Cannabis Wire previously reported.
When it comes to food, whether for humans or animals, the FDA is brief and firm: “It is not currently lawful to add CBD to human or animal food, and the data currently available to FDA raise safety concerns about the use of CBD in food. We encourage interested parties to continue to develop and share with FDA information regarding whether there are conditions under which CBD could safely be added to food.”
This reiterates a position they took in November, which gave the industry pause, when the Administration said “Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.” (Read Cannabis Wire’s coverage of this announcement.)
When it comes to supplements, the FDA tone noticeably shifts. While the FDA emphasizes that allowing CBD in dietary supplements will pose a number of hurdles when it comes to oversight of the marketplace and bad actors, the Administration writes that they “recognize the high level of interest,” are “actively considering potential pathways” for these products, and are “actively evaluating what and how much data would be sufficient” for them to allow these supplements to hit shelves.
The FDA continues: “Given the significant public interest in the potential for CBD dietary supplements, as well as the extent to which many such products are available on the market, FDA has been taking a highly proactive approach to analyzing relevant safety questions. Rather than waiting for data to be submitted, we have been actively working to identify and review all available data to understand the risk profile of CBD and the potential for CBD to be safely included in dietary supplements, under certain conditions of use.”
They announced that they are creating a process for companies to securely share “proprietary information regarding specific products,” which could “help inform appropriate regulatory steps,” as much of the data FDA currently has pertains to CBD itself, not supplements containing CBD.
Finally, on the supplements front, FDA made an interesting announcement about “evaluating issuance of a risk-based enforcement policy,” which, in other words, means that instead of playing enforcement whack-a-mole, they will prioritize with product risk in mind.
The report also provided updates on the FDA’s efforts when it comes to areas like research and global collaboration.
On new research: the FDA’s National Center for Toxicological Research is launching studies this year on “CBD exposure during pregnancy,” and the FDA, in partnership with the University of Mississippi, will look at “dermal penetration” of topical cosmetic THC and CBD products. In general, the report emphasizes the importance of research when it comes to regulation, writing, “If the widespread availability of consumer CBD products were to significantly discourage clinical research, our knowledge of CBD’s potential medical uses could be stunted.”
On global collaboration: the FDA shared that they have met with regulators from Canada, Israel, and Scotland, among others, to discuss “cannabis and cannabis-derived compounds.”
On sampling the marketplace: in response to a directive from Congress to “determine the extent to which products are mislabeled or adulterated,” FDA says it is “developing an action plan for product sampling.”
On public comment: last May, FDA held its first public meeting on CBD, and opened a public docket. Now, that docket “will remain open indefinitely.” The goal is to collect more data to inform regulation, from a variety of stakeholders, including not just those in the industry, but academics and other researchers.
There are a number of questions the FDA is seeking to answer, including but not limited to: the effects of regular CBD use; what level of CBD presents risks; risks associated with consumption methods.
Some of their questions are more specific, such as: “Does CBD cause male reproductive toxicity in humans, as has been reported in studies of animals?” and “Are any residues formed in edible tissues of food producing animals?”
