FDA calls for more authority to oversee CBD products

The agency wants Congress to intervene, saying it lacks adequate oversight powers to ensure the myriad of products are safe. of hemp-derived cannabidiol.

Four years after Congress legalized hemp, spawning a vast, unregulated market for cannabidiol-infused drinks, gums and lotions, the The Food and Drug Administration said Thursday it has no authority to regulate such products. Instead, the agency called on federal lawmakers to give it a stronger regulatory framework to address the health claims and safety concerns that have obsessed the prolific CBD industry.

Dr. Janet Woodcock, the F.D.A.'s senior deputy commissioner, said the agency's existing regulatory methods governing the sale of food additives and dietary supplements were inappropriate for products containing CBD, the chemical derived from hemp. promoters credit it with a dizzying array of health benefits.

Unlike tetrahydrocannabinol, or THC, the component of cannabis that gets users high, CBD is not psychoactive. But there is little data to back up marketing claims that CBD can prevent diabetes, ease anxiety, or ease menstrual cramps.

In a statement, the Dr Woodcock told an internal committee she led at the agency was concerned about the general paucity of scientific literature on CBD and that some research suggested long-term use could be associated with liver toxicity and to damage to the male reproductive system. It was also unclear whether CBD was safe for pregnant women and children. "For example, we did not find sufficient evidence to determine how much CBD can be consumed and for how long before causing harm," she said.

The agency, which has a stricter review process for prescription drugs, has very lax oversight powers for consumer products like cosmetics and dietary supplements. It does not screen these products before they hit the market, but primarily responds to complaints about unsafe ingredients before investigating or trying to get them removed from store shelves.

While waiting for Congress to decide whether to give it more oversight, the agency will continue to take action against companies that make specific health claims about CBD products, she said. "We will remain diligent in monitoring the market," Dr Woodcock said.

Industry groups expressed disappointment with the decision. They said they fear the case will languish in a tightly divided Congress, despite bipartisan support for an industry that has grown to nearly $6 billion in the four years since lawmakers pulled hemp from the market. the federal list of controlled substances.

"The idea that we have to start from scratch on an entirely new regulatory path is of great concern to us," said Jonathan Miller, attorney for the U.S. Hemp Roundtable, a trade association.

He and other industry supporters had urged the F.D.A. use existing regulatory frameworks for CBD. On Thursday, the agency definitively rejected that idea, rejecting petitions from three groups that had asked the F.D.A. to regulate CBD products in the same way it oversees food ingredients like caffeine, ginseng, and echinacea.

Jonathan Havens, former legal counsel to the F.D.A. who now represents companies in the CBD industry, said many growers and manufacturers have grown frustrated with the F.D.A.'s inaction, which has contributed to a chaotic market that has created consumer confusion and uncertainty. finance for businesses.

"The F.D.A. never wanted to deal with this issue," he said. "And while that's unfortunate , it would be less unfortunate if we knew that in 2018 and Congress could have dealt with it, especially at a time when Congress was not so sharply divided and bills emerged more regularly from both houses and reached the president's office. ."

Amid the regulatory vacuum, more than two dozen states have taken...