Convergence: FDA looking for ‘a new way forward’ on CBD regulation

MONTREAL – The US Food and Drug Administration (FDA) is open to developing a new regulatory framework for cannabidiol (CBD), according to an agency official who spoke at RAPS Convergence 2023.

“FDA is committed to sound, science-based policy on CBD,” said Owen McMaster, a senior pharmacology/toxicology reviewer with the Division of Pharm/Tox for Infectious Diseases (DPT-ID) in the Office of Infectious Diseases (OID) in FDA’s Center for Drug Evaluation and Research (CDER).

“We look forward to working with Congress on a new way forward -- a harm reduction, regulatory approach,” he said.

Interest in cannabis-related products and cannabis sativa has grown over the last decade. While the FDA has received 800 Investigational New Drug (IND) applications for cannabis-related products within the last 50 years, 400 IND applications have been submitted within the 10 years. The agency currently has 150 active INDs in the areas of addiction, pain, medicine, neurology, immunology and inflammation, McMaster said.

CBD has a current estimated market size of at least $4 billion, McMaster noted. “If the agency produces guidance regarding how CBD can be safely sold, then it's expected that that will increase at a faster pace than it is increasing right now, but we’re working very hard on the regulations,” he said.

McMaster explained FDA has received several citizen petitions requesting that the agency allow CBD products to be regulated as dietary supplements. “Unfortunately, the existing regulatory frameworks that we have for foods and supplements are not appropriate for CBD. It's not apparent how CBD products can meet the safety standards for dietary supplements or food additives,” he explained.

When regulating drugs, FDA uses a safety standard that considers the risks and benefits for individuals with a specific medical condition, while dietary supplements “are used by a broader group” of individuals who want to supplement diet and maintain health. For foods and dietary supplements, the standard is that the product has a reasonable expectation of safety. “The benefits are not considered,” McMaster said.

A working group tasked with examining studies on CBD-related products, such as Epidiolex, released a statement in January 2023 explaining their reasoning behind concluding that CBD could not meet safety standards for dietary supplements or food additives. Considerations included a lack of evidence on safe consumption levels for CBD and for safe duration of consumption. The working group also found risks associated with administering CBD to animals, and a potential exposure risk for humans who consume meat, milk and eggs from animals who have received CBD (RELATED: This Week at FDA: PDUFA and BsUFA hires, cannabis guidance, and more, Regulatory Focus 27 January 2023).

“A new regulatory pathway needs to be to be developed,” McMaster said. “A new regulatory pathway would benefit consumers by providing safeguards and oversight to manage and minimize risks related to CBD products.”

However, a Congressional mandate is needed in order for FDA to begin work in this area, he noted.

In October 2022, the White House released a statement that requested the US Secretary of Health and Human Services and the Attorney General review how cannabis is scheduled under federal law. A decision by the Drug Enforcement Administration is pending, McMaster said.

Meanwhile, McMaster said FDA is committed to enforcement efforts that target high-risk drugs, and “will continue to take action against CBD and other cannabis-derived products to protect the public in coordination with state regulatory partners, where appropriate.”

“We will remain diligent in monitoring the marketplace and acting within authorities,” he said.

Convergence: FDA looking for ‘a new way forward’ on CBD regulation

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