‘Large, innovative’ CBD sector needs balanced rules, says FDA advisor

Federal CBD policy should advance research that can inform consumers about risk while at the same time giving stakeholders regulatory certainty, a senior advisor at the U.S. Food and Drug Administration (FDA) said this week.

The comments, from Norman Birenbaum, the FDA’s senior public health advisor on cannabis policy, come as the FDA and Congress are set to work together on new laws aimed to tamp down a flourishing CBD gray market and establish enduring rules for the compound.

Acknowledging that many consumers have “folded these products into their daily lives,” Birnbaum said those consumers must be made aware of the potential risks.

Industry ‘deserves’ clarity

At the same time, “industry participants deserve the regulatory certainty that can come with an appropriate regulatory pathway,” Birenbaum said during a virtual discussion hosted by the Washington, D.C.-based Council for Federal Cannabis Regulation Thursday.

Calling the CBD sector both “large” and “innovative,” Birnbaum said there is “a huge wide open lane to move down in terms of pursuing harm reduction and harm mitigation and not letting the perfect be the enemy of the good” when it comes to safety issues.

“It is not saying we need to understand every single facet of the safety profile of this product, but being able to say to consumers, here’s what we don’t know or here’s what we do know, here is what the risk profile may be,” he said.

“The real question is how can we encourage research and invest in research without undermining consumer safety and also without undermining the existing drug pathway when it comes to products that are making therapeutic claims?” Birenbaum said.

Turning to Congress

After having been responsible for oversight of CBD since 2018, FDA declared in January that existing federal safety standards are insufficient to manage the industry, and called on Congress to set rules for the products through legislation. FDA simultaneously released a set of non-binding recommendations for CBD.

CBD stakeholders, on the other hand, have argued that existing regulatory pathways for dietary supplements and foods, and rules covering the manufacturing, labeling, and marketing of products are sufficient for regulating the sector.

FDA currently recognizes CBD as a drug, technically barring it from use in foods or being marketed as a dietary supplement.

Stakeholders have long called on the FDA to clarify CBD’s status. But the agency has been slow to move, focusing instead on enforcement and issuing warnings to CBD makers operating in the gray market or under state regulations where rules have been set. 

Safety questions

FDA has repeatedly cited studies that say CBD could harm the liver and male reproductive system, and said little is known about how it interacts with drugs, and its effects on children and pregnant women.

The agency has also expressed alarm over delta-8 THC products, which are made from hemp-derived CBD, calling the rapid growth of such products “extraordinarily concerning.” The U.S. Drug Enforcement Administration asserted just last week that delta-8 and other forms of hemp-based synthetic THC fall under narcotics laws.

FDA has authority over CBD and other hemp-derived cannabinoids under provisions in the 2018 U.S. Farm Bill; that authority extends over all forms of cannabis compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and the Public Health Service Act.