The Food and Drug Administration said on Thursday that it will work with Congress to figure out how to regulate the CBD industry, marking one of the agency’s most significant cannabis-related announcements to-date.
“Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products,” FDA Principal Deputy Commissioner Janet Woodcock announced on Thursday.
“Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter.”
The 2018 Farm Bill legalized hemp, defined as cannabis plants with .3% THC or less, and unleashed a hemp-derived CBD industry from coast to coast. The FDA was subsequently tasked with crafting regulations for products, like CBD, derived from these low-THC cannabis plants, for which the cannabis industry has waited with increasing impatience. Lawmakers, advocates, and industry stakeholders alike have pushed for years for CBD to be allowed in foods and considered a dietary supplement.
On Thursday, the FDA rejected three citizen petitions regarding supplements. And, Woodcock wrote that they “do not intend to pursue rulemaking” that allows for the use of CBD in dietary supplements, foods, or animal foods.
However, the Administration committed to finding a path forward, at least for some products, alongside Congress.
“A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products,” the FDA noted in its announcement. “Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.”
What about the existing, unregulated CBD industry, which is booming online and in brick-and-mortar retail locations, from grocery stores to beauty shops and gas stations? While the FDA has mostly sent warning letters to CBD sellers who peddle false health claims, a more robust approach could be on the horizon.
“The FDA will continue to take action against CBD and other cannabis-derived products to protect the public, in coordination with state regulatory partners, when appropriate,” the FDA announced. “We will remain diligent in monitoring the marketplace, identifying products that pose risks and acting within our authorities. The FDA looks forward to working with Congress to develop a cross-agency strategy for the regulation of these products to protect the public’s health and safety.”
FDA Commissioner Robert Califf foreshadowed Thursday’s announcement in May 2022, when he talked about the need for a “new” approach, as Cannabis Wire reported at the time.
“I am very committed to taking a path on this,” he said during a hearing on the FDA’s FY 2023 budget in the House Appropriations subcommittee on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies. “And just to put a marker down, I don’t think the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward. We’re going to have to come up with something new.”
Califf continued, “I’ve told you, and I really mean it, I’m committed to do something about this and it’s going to take some work. I hope that you’ll work with me on that because it’s going to take some creativity.”
Several other changes took place at the FDA in 2022 in an effort to bolster its efforts around CBD, and around cannabis more broadly. The formed a Cannabis Products Council, to be chaired by Janet Woodcock, the FDA’s Principal Deputy Commissioner. Then, the FDA’s Center for Drug Evaluation and Research announced that it hired Norman Birenbaum, a former cannabis regulator and the founding president of the Cannabis Regulators Association (CANNRA), as a senior public health advisor “responsible for advancing our efforts related to research and regulation of cannabis.”
The FDA is also tasked with undertaking a scientific review of cannabis following President Joe Biden’s October 2022 announcement that he is calling on his administration “to initiate the process of reviewing how marijuana is scheduled under federal law.” Cannabis has been in Schedule I of the Controlled Substances Act, a category reserved for substances with the highest potential for misuse and no medical value, since the 1970s. The FDA will then give its scheduling recommendation to the Drug Enforcement Administration.
“We are working diligently on looking at the scheduling of marijuana under the Controlled Substance Act,” Woodcock said in October, as Cannabis Wire reported, and “what flexibilities we might have there. So that is a very high priority that the secretary of [Health and Human Services] is very interested in. We’re working closely with our partners at [the National Institute on Drug Abuse] and also with the assistant secretary for health.”
