CRN urged FDA to act quickly, as the market for these products, whether technically legal or not, is exploding. CRN filed its comments as part of its participation in the May 31 meeting the agency convened in Washington, DC on the issue.
“The market for hemp-derived CBD products is expected to exceed over $500 million by the end of 2021. Further, as attendees at FDA’s May 31 Public Meeting learned, based on a recent survey by Consumer Reports, an estimated 64 million Americans (more than 25% of the U.S. population) have tried CBD within the past two years,” CRN wrote in its comments.
Current FDA position blocks progress on issue
From the trade organization’s point of view FDA has the authority to regulate the CBD market in a timely manner and it a way that is in line with the intent of Congress. At the moment, the agency is hamstrung by its stance that CBD is subject to the exclusionary clause in the Dietary Supplement Health and Education Act that prevents the use in supplements of a substance that was first developed as a drug.
“The position that FDA has taken basically is preventing it from taking action on existing provisions in the law,” Andrew Shao, PhD, interim chief science officer of CRN told NutraIngredients-USA.
This stance has prevented FDA from making its own safety evaluation of CBD. One of the ways this could have been done is for the agency to evaluate a New Dietary Ingredient Notification on a hemp/CBD ingredient.
But in the few instances that companies have tried to file a NDIN on a CBD ingredient, FDA has checked the first box of “not a legal dietary ingredient” and did not comb through the rest of the submission. It’s a similar process the agency goes through when it finds an ingredient has not been sufficiently characterized in a notification.
“The agency did even get to the point of evaluating the safety information,” Shao said. “It’s sort of a Catch 22.”
Safety not in question
In any case, CRN maintained in its comments that the safety of CBD has been broadly established. Shao said the recent studies on liver toxicity with CBD published by Igor Kortubash, PhD and Bill Gurley, PhD at the University of Arkansas (Dr Gurley has since moved to the National Center for Natural Products Research at the University of Mississippi) add detail and context to this picture, but do not alter the overall conclusion.
“Those studies that were done by Dr Gurley and Dr Kortubash help to inform the evidence base. But there was already a whole bank of literature on the safety of CBD,” Shao said.
In its comments, CRN summed up its views this way:
“(1) FDA already has the authority to allow CBD use in food and supplements; (2) exercising this authority will provide FDA the flexibility to appropriately address safety in the fact-specific manner that the Food, Drug, and Cosmetic Act (FDCA) and FDA regulations intended; (3) authoritative reviews have found that CBD is likely safe when used by healthy adults and, as such, can be regulated by FDA like any other botanical ingredient; and (4) allowing CBD to be used in food and dietary supplements is unlikely to disincentivize drug research and development and, in fact, could stimulate research, which in turn would continue to improve public health.”