As Dr. Robert Califf’s nomination as FDA commissioner comes to the Senate for debate and approval, it is clear he has a tall order to fill. The COVID-19 pandemic has exposed FDA’s continuing challenge to restore public confidence in the aftermath of its opioid debacle.
Fortunately, there’s one area where Dr. Califf can take immediate action to bolster FDA’s credibility: directing the agency to finally regulate the growing hemp and CBD marketplace.
It’s been more than three years since the enactment of the 2018 Farm Bill, which explicitly legalized hemp and clarified FDA’s jurisdiction over ingestible and topical hemp products. Within hours of the bill signing, then-FDA Commissioner Scott Gottlieb recognized the “clear interest of Congress in fostering the development of appropriate hemp products” and acknowledged FDA “has the authority to issue a regulation,” which would allow for marketing. But since then, the agency has taken no concrete action. Indeed, in recent months, Acting Commissioner Dr. Janet Woodcock reversed course, arguing the law is “fairly clear,” barring the agency from further action on CBD and putting the agency in a “stalemate position.”
Woodcock’s position—that FDA’s hands are tied by the drug exclusion rule—rests on tenuous factual and legal grounds: There’s plenty of evidence that CBD was marketed as a dietary supplement before it was substantially investigated for its application as a drug. But even beyond that, FDA has placed impossible, hypocritical burdens on CBD manufacturers to demonstrate product safety. The agency recently rejected two comprehensive new dietary ingredient notifications, holding hemp to a much higher standard than its regulations contemplate.
At the same time, the real public health problem remains unaddressed: As FDA’s own studies demonstrate and its own warnings counsel, many products continue to be sold under the guise of the hemp name that raise significant quality, safety, intoxication and other consumer protection concerns since the agency is not ensuring these products are in compliance with federal regulations.
Meanwhile, farmers, businesses and consumers suffer. FDA’s extra-statutory and unenforced position that the sale of ingestible CBD is illegal continues to put a cloud over the industry, restricting demand, crushing prices and leaving hemp growers with mountains of unsellable biomass. Companies endeavoring to sell compliant hemp products contend with a patchwork of inconsistent and burdensome state regulations.
Many in Congress have had enough. HR 841, which would require FDA to regulate hemp extracts like CBD as dietary supplements, already features 37 co-sponsors, with 24 Democrats and 13 Republicans. HR 6134, recently introduced by a bi-partisan coalition, would extend regulatory protection for CBD in food and beverages. And S. 1698, sponsored by four leading U.S. senators, would provide a regulatory pathway for all ingestible hemp products. Hearings on these bills have been delayed due to other priorities but should be expected in the new year.
If confirmed as FDA commissioner, Califf could use existing authority to apply the same regulations to hemp as the agency does for all other dietary supplements and food and beverage additives. Doing so would take a small step towards restoring public trust in the agency. Hopefully, he will see that FDA’s lack of action contradicts his agency’s mission to protect public health and safety. If he fails to act, Congress will need to take action soon.
Jonathan Miller is the general counsel of the U.S. Hemp Roundtable, the hemp industry’s national advocacy organization.