The U.S. Food and Drug Administration (FDA) recently issued a 15-page report to Congress as well as a public update about its progress toward regulating cannabidiol (CBD) in food and other products.
In its report to Congress, the FDA says it’s “actively considering potential pathways for certain CBD products to be marketed as dietary supplements” and is seeking both its own and outside research on multiple facets of the cannabinoid.
But the memo has been met with criticism by industry organizations who see the update as more of the same.
“We’re disappointed,” says Jonathan Miller, general counsel to the U.S. Hemp Roundtable. “We’ve been waiting over a year for the FDA to develop a regulatory regime for the sale of CBD, but this is another exercise of kicking the can down the road.”
In its update, the FDA says it will continue taking action against products with CBD that are illegally being marketed, especially those that make false health claims. Of all the products containing CBD on the market, only one has been approved by the FDA—Epidiolex, a prescribed oral solution used to treat two rare, severe forms of epilepsy.
The agency is currently seeking more data on CBD through multiple avenues, one of which includes re-opening its CBD public docket indefinitely for stakeholders to share relevant information. The agency says it is also “encouraging, facilitating and initiating more research on CBD, providing venues for industry and researchers to share new data with the agency and identifying opportunities to further collaborate with our federal partners at Centers for Disease Control and Prevention, Substance Abuse and Mental Health Services Administration and National Institute on Drug Abuse on this important issue.”
Research the FDA says it is currently conducting includes looking into CBD exposure during pregnancy. The FDA says it has also partnered with the University of Mississippi to evaluate the levels of CBD and tetrahydrocannabinol (THC) in cosmetic products to assess their effects when applied topically.
The FDA says it is currently seeking data on:
the sedative effects of CBD
the impacts of long-term or cumulative exposure to CBD
transdermal penetration of CBD
the effect of different forms of CBD products and how they impact its safety
the safety of CBD for animals
the processes for deriving full spectrum and broad spectrum hemp extracts and how these products may compare to CBD isolate products
“As data become available that are high-quality, reliable and relevant to our evaluation of CBD products that fall under the FDA’s purview, we will be able to refine–and, perhaps in some cases, revise–our thinking and approaches,” the FDA says.
The FDA also said it is exploring a “risk-based enforcement policy” on CBD products to give “greater transparency” regarding its enforcement.
However, noticeably absent from the FDA’s update is a timeframe of when regulations may be in place.
“The hemp industry is really struggling because of this cloud the FDA has put on it,” Miller says. Meanwhile, he adds, thousands of unregulated CBD products are on the shelves of stores, potentially putting consumers at risk. “We think it’s the worst of both worlds,” Miller says about the lack of FDA guidance.
He adds that he hopes Congress will continue putting pressure on the FDA to issue relevant guidance in the near future.
