CBD stakeholders in the USA say an update from the U.S. Food & Drug Administration (FDA) released Friday has done little to advance the process of establishing a regulatory framework for the compound, hampering CBD companies and leaving consumers vulnerable as products continue to flood the market.
The update, “Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol Products,” acknowledges that CBD is now widely available to consumers, but repeated the oft-used refrain that the agency still has “a limited understanding of the safety profile of CBD and many other cannabis-derived compounds.”
“We still don’t have clear answers to important questions such as what adverse reactions may be associated with CBD products and what risks are associated with the long-term use,” FDA Commissioner Stephen Hahn and Principal Deputy Commissioner Amy Abernethy wrote in Friday’s summary. “Better data in these areas are needed for the FDA and other public health agencies to make informed, science-based decisions that impact public health.”
Failure to lead
That drew a strong rebuke from trade group the Council for Responsible Nutrition (CRN), whose president, Steve Mister, called Friday’s statement “nothing more than an end-of-administration desk-clearing exercise from an FDA that has failed to lead in this crucial policy area.” CNR represents ingredient suppliers and manufacturers in the U.S. dietary supplement industry.
“Because of the FDA’s failure to act, the public continues to be exposed to possible harms by a wild-west market that continues to expand without meaningful regulatory bounds,” Mister told Food Navigator .
In the absence of federal guidelines, CBD makers and consumers are faced with inconsistent rules – or no rules at all – in individual states, creating problems for legitimate CBD vendors and endangering public health. FDA, meanwhile, has emphasized cracking down on mislabeled and adulterated products, and those that make unsubstantiated health claims. But enforcement has come in the absence of significant research and meaningful progress on CBD regulation at the FDA, critics charge.
Who’s in charge?
The jurisdiction of hemp-derived products in the U.S. moved from the Drug Enforcement Administration to the Department of Agriculture with passage of the 2018 Farm Bill, which removed industrial hemp from Schedule 1 of the Controlled Substances Act. FDA meanwhile asserted its authority to regulate products derived from cannabis, including hemp, and therefore has a major role to play in the development of markets for hemp-derived CBD, food, cosmetics and drugs in the United States.
But the agency, characteristically slow to move, has done little to advance research on the safety issues it raises. While FDA is authorized to run clinical trials on human foods, drugs, dietary supplements, food additives, cosmetics, animal foods and tobacco products, the agency has “done little that might incentivize data to be presented, or invested in research of its own,” CRN ‘s Mister asserted.
In a summary on research, the agency said: “While the FDA appreciates the information and engagement from numerous stakeholders on CBD-related issues, many evidence gaps remain. Filling these gaps will not be a trivial exercise but will require high-quality data analyzed using robust methods. We believe there is an opportunity to develop better sources of RWD to provide incremental improvements in our scientific understanding of the safety profile of CBD in the general population and, potentially, in specific populations.”
Clarity in Europe
The FDA has shown it can move on CBD when it wants to. The agency acknowledged the benefits of cannabis use for seizure disorders with the approval in 2018 of Epidiolex, which has helped patients who suffer Dravet Syndrome and Lennox-Gastaut Syndrome, two debilitating forms of epilepsy. The product, which contains high levels of both THC and CBD (100 milligrams per milliliter), was the first cannabis-derived prescription drug to gain FDA approval.
The challenges facing CBD regulation in the United States are similar to those faced in many parts of the world. Significant clarity was brought to the European market late last year when the European Union ruled that CBD should not be considered a drug in the context of the United Nations Single Convention on Narcotic Drugs of 1961, recognizing CBD as a food that may be freely traded across EU member states, and setting the stage for EU-wide regulation.