FDA has many “unanswered questions” when it comes to the safety of cannabidiol (CBD), a cannabis-derived compound, the agency’s top official said last week.

FDA Acting Commissioner Norman "Ned" Sharpless, M.D., cited “real risks” and “critical questions” that remain regarding the safety of CBD and tetrahydrocannabinol (THC) in FDA-regulated products, including food and dietary supplements.

During a May 31 public hearing at FDA’s campus in Silver Spring, Maryland, more than 100 speakers representing myriad interests addressed CBD and THC issues, including FDA’s prospective regulation of cannabis-derived compounds.

The hearing was intended to obtain scientific data and information about the labeling, manufacturing, marketing, product quality, safety and sale of products containing cannabis or cannabis-derived compounds.

Sharpless underscored FDA has many questions about CBD that remain unanswered.

“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” he said.

Sharpless suggested population-based research focused on CBD was scant prior to the passage of the Agricultural Improvement Act of 2018, otherwise known as the Farm Bill, which removed hemp and its derivatives from the Controlled Substances Act (CSA).

The “lack of evidence to support CBD’s broad use in FDA regulated products—including in food and dietary supplements—has resulted in unique complexities for its regulation,” he said, “including many unanswered questions related to … safety.”

For instance, Sharpless asked a fundamental question about CBD: How much of the compound is safe to consume in a day?

“What if someone applies a topical CBD lotion, consumes a CBD beverage or candy and also consumes some CBD oil?” Sharpless asked. “How much is too much?”

Sharpless also asked how CBD would interact with other drugs taken by a person, and he left unanswered the question of how the compound would impact the health of a pregnant women.

“What if children access CBD products like gummy edibles?” the commissioner asked. “What happens when someone chronically uses CBD for prolonged periods?”

FDA has concluded CBD and THC—the psychoactive compound responsible for the “high” from consuming marijuana—cannot be added to conventional food or marketed in a dietary supplement because the compounds were first studied as drugs. But FDA has authority to create an exception by issuing regulations, a process that could take several years.

FDA has opened a docket on the public hearing and is accepting comments through July 2, 2019. Some speakers said they wanted FDA to extend the deadline.

The agency has already received more than 1,100 comments, reflecting substantial interest in a cannabis-derived compound that has proliferated in food, dietary supplements and other FDA-regulated products over the last five years.

Enforcement  

Since 2015, FDA has issued warning letters to companies selling unapproved CBD products.

“Our biggest concern is the marketing of products that put the health and safety of consumers at risk,” Sharpless said, “such as those claiming to prevent, diagnose, mitigate, treat or cure serious diseases, such as cancer, in the absence of requisite approvals.”

Sharpless said consumers may be using such products to treat diseases instead of proven therapies. But the agency has not made any promises to leave alone marketers of unapproved CBD products who refrain from making claims of treating a disease.

FDA, he said, “does not have a policy of enforcement discretion with respect to any CBD products.”