Cannabis-related products have flooded the market, making health claims about pain relief, immune function and anxiety and depression. But the US Food and Drug Administration says there is little known about how effective they are. On Friday, the FDA held its first hearing to assess the safety and efficacy of CBD products.
In opening the hearing Dr. Ned Sharpless, acting commissioner of the FDA, said despite the widespread use of such products “critical questions remain about the safety” of these items.
Products touting CBD and THC – two of the active ingredients in cannabis – can be found in foods, dietary supplements, and even cosmetics.
“While we have seen an explosion of interest in products containing CBD, there is still much that we don’t know,” said Sharpless.
CBD, also known as cannabidiol, is the ingredient in marijuana and hemp touted to have many medicinal benefits. It’s different from tetrahydrocannabinol or THC, the main psychoactive component of cannabis.
Sharpless pointed out that prior to the passage of last year’s farm bill, which removed hemp as a controlled substance, much of the research into cannabis looked at the plant as a whole, rather than specific components like CBD.
“When hemp was removed as a controlled substance, this lack of research, and therefore evidence, to support CBD’s broader use in FDA-regulated products, including in foods and dietary supplements, has resulted in unique complexities for its regulation, including many unanswered questions related to its safety,” he said.
Today’s hearing, he said, would inform the agency as it moved forward with determining how to regulate CBD.
‘Only limited available information about CBD’
Last June, the FDA for the first time approved a cannabis plant-derived, CBD-based drug, Epidiolex, which is approved to treat two severe and rare forms of epilepsy: Dravet Syndrome and Lennox-Gastaut syndrome.
Dr. Amy Abernathy, principal deputy commissioner of the FDA and head of the agency’s CBD working group, said in a tweet last week, “The FDA has not approved any other CBD-containing products. We want consumers to be aware that there is only limited available information about CBD, including about its effects on the body.”
Witnesses from the supplement industry, researchers, doctors and patients are all expected to testify about their experiences with cannabis at Friday’s hearing. The agency will also make a docket available for public comments that will close on July 2.
In April, then-FDA commissioner Dr. Scott Gottlieb warned in a statement that “open questions remain regarding the safety” of widespread use of CBD products. He also noted there are concerns about a lack of standards around CBD concentrations in products and the possible impacts of long-term CBD use.
“It’s critical that we address these unanswered questions about CBD and other cannabis and cannabis-derived products to help inform the FDA’s regulatory oversight of these products,” he said. “Especially as the agency considers whether it could be appropriate to exercise its authority to allow the use of CBD in dietary supplements and other foods.”
It is illegal to introduce CBD or THC into the food supply or market it as a dietary supplement. Marijuana remains illegal under federal law. However, at least 10 states have moved ahead and legalized the purchase and possession of recreational marijuana while 33 states allow the use of medical marijuana.
A market in the billions
As states have liberalized the use of