FDA Won't Endorse CBD as 'Generally Recognized as Safe'

In a potential blow to the hottest-selling hemp product, the FDA said it "cannot conclude that CBD (cannabidiol) is generally recognized as safe among qualified experts for its use in human or animal food" because of a lack of scientific evidence. The warning came as USDA gathers public comment on a rule that opens the way for nationwide cultivation of industrial hemp in the new year.

CBD fetches the highest price at present among hemp products but there are two other markets, fiber for use in apparel and the grain and seed sector, including use in food or livestock rations. Analysts such as agricultural lender CoBank say there are many risks in hemp from lack of processing capacity to uncertain direction of federal regulation. CBD is sold in a regulatory gray market because the FDA has not approved it for use in food or dietary supplements.

All the same, industrial hemp has created a buzz among farmers looking for a new, profit-making crop. Some 230,000 acres of hemp were planted this year, according to advocacy group Vote Hemp. The 2018 farm bill legalized cultivation of industrial hemp, with USDA overseeing state regulation of growers.

"Given the gaps in research noted by FDA, CBD makers have an uphill battle on their hands," said the Center for Science in the Public Interest. The consumer group said FDA's "new and notable" announcement that it cannot conclude CBD is safe "means just about everyone selling CBD in a food is breaking the law."

The FDA warned against use of CBD as part of a crackdown on companies that sell it as a cure for diseases or as a therapeutic product. There is scant scientific information about the safety of CBD, its side effects or how it interacts with medications, said the agency. Nonetheless, the FDA said it was exploring potential pathways for CBD products to be sold legally. An update will be released "in the coming weeks," it said. Only one prescription drug containing CBD, for treatment of two rare forms of epilepsy, has FDA approval.

"We remain concerned that some people wrongly think that the myriad CBD products on the market, many of which are illegal, have been evaluated by the FDA and determined to be safe, or that trying CBD 'can't hurt'…there are real risks that need to be considered," said Amy Abernethy, principal deputy FDA commissioner. "We recognize the significant public interest in CBD and we must work together with stakeholders and industry to fill in the knowledge gaps about the science, safety, and quality of many of these products."

In a warning letter to an Oregon company, the FDA cited a CBD product that could be fed to food-bearing animals. The agency said it was concerned "about the safety of human food products (e.g., meat, milk, and eggs) from animals that consume CBD, as there is a lack of data establishing safe CBD residue levels."

Stephen Hahn, the Trump nominee for FDA commissioner, said during a Senate confirmation hearing that he wanted to see more research into "open and unanswered questions" about CBD, reported Hemp Industry Daily.

The USDA has a December 30 deadline for comment on its interim final rule on hemp cultivation. The interim rule will be in effect for two years, allowing a "test drive" of regulations in 2020 and revisions as warranted before a final regulation is written.

The FDA website on cannabis and cannabis-derived products is available here.

An FDA Consumer Update on CBD products is available here.