FDA concludes that "new regulatory pathway for CBD is needed"

After extended study, the federal Food and Drug Administration has decided it cannot figure how to regulate cannabidiol (CBD). This FDA press release explains its decision, and here are excerpts:

Given the growing cannabidiol (CBD) products market, the U.S. Food and Drug Administration convened a high-level internal working group to explore potential regulatory pathways for CBD products. Today we are announcing that after careful review, the FDA has concluded that a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks. The agency is prepared to work with Congress on this matter. Today, we are also denying three citizen petitions that had asked the agency to conduct rulemaking to allow the marketing of CBD products as dietary supplements.

The use of CBD raises various safety concerns, especially with long-term use. Studies have shown the potential for harm to the liver, interactions with certain medications and possible harm to the male reproductive system. CBD exposure is also concerning when it comes to certain vulnerable populations such as children and those who are pregnant.

A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products. Some risk management tools could include clear labels, prevention of contaminants, CBD content limits, and measures, such as minimum purchase age, to mitigate the risk of ingestion by children. In addition, a new pathway could provide access and oversight for certain CBD-containing products for animals.

The FDA’s existing foods and dietary supplement authorities provide only limited tools for managing many of the risks associated with CBD products. Under the law, any substance, including CBD, must meet specific safety standards to be lawfully marketed as a dietary supplement or food additive.

The working group ... has closely examined studies related to the CBD-based drug Epidiolex, published scientific literature, information submitted to a public docket, as well as studies both conducted and commissioned by the agency. Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.

This Washington Post article about the decision highlights some industry grumpiness and the broader context:

“When it comes to the safety of CBD, the FDA gets it wrong,” Jonathan Miller, general counsel of the U.S. Hemp Roundtable, said in a statement. He called the agency’s intent to tighten regulations “unprecedented and unnecessary” but said he endorsed a legislative solution to allow marketing of CBD in dietary supplements and foods.

Alex Buscher, a Colorado-based lawyer who advises hemp companies, said that CBD doesn’t seem to be riskier than other dietary supplements on the market that have the potential for side effects if taken at higher-than-recommended doses. “The FDA is kicking the decision back to a divided Congress, which will take time to create a new regulatory framework,” he said. “We need actual regulation from the FDA.”Advocacy groups and food industry experts criticized the FDA decision.

Food safety experts have said that the FDA has been in an impossible situation as states have decriminalized marijuana — which remains illegal under federal law — and related products have gained popularity. According to the National Conference of State Legislatures, as of this past February, 37 states (plus D.C., Puerto Rico, Guam and the U.S. Virgin Islands) have legalized medical use. As of Nov. 9, 21 states (plus D.C., Guam and the Northern Mariana Islands) have decriminalized recreational use — a strong indication that public sentiment has shifted.

“I’m sure the FDA probably concluded that no matter which way they went, it would involve trying to fit a very big genie back into a very small bottle, and create a political firestorm,” said Brian Ronholm, director of food policy for Consumer Reports. “It’s not surprising that they would want to seek some cover from Congress.”