Dietary supplement industry groups are pressing FDA to legalize the use of the hemp cannabinoid cannabidiol (CBD) in dietary supplements, but FDA is wary of setting a bad precedent by authorizing CBD supplements without convincing safety data, said an FDA commissioner. Lowell Schiller, FDA principal associate commissioner for policy, told attendees of the Council for Responsible Nutrition’s 2019 The Conference in Carlsbad, CA, on Thursday, November 7, that the agency is concerned with the message it would send to the public if FDA were to create a legal exception for CBD at this time.
During his speech to conference attendees, Schiller said that FDA’s biggest concern regarding CBD is whether or not CBD is safe for people to consume in food and supplements. (Drugs are a different matter. FDA already approved the CBD drug Epidiolex last summer.)
In October, leading industry trade associations sent a joint letter asking Congress to create and pass legislation that would establish CBD as a lawful dietary ingredient by creating a waiver of § 201 (ff)(3) the Federal Food, Drug, and Cosmetic Act (21 U.S.C. § 321(ff)(3)(B)).
At the CRN conference, Schiller said that even as FDA mulls the request to create a legal pathway to market for CBD in dietary supplements and food, the agency is still concerned about CBD’s limited safety data. “[W]e’ve been getting requests to look at [an] exemption, which allows FDA to go through notice-and-comment rulemaking to issue a regulation excluding CBD…As we consider this issue, safety is top of mind,” Schiller said.
Currently, Schiller said, FDA does not feel it has enough data to determine whether CBD is safe for consumers in supplements and food. “At FDA, we’re trying to learn as much as we can about CBD as quickly as we can,” he said. “But there’s still much we don’t know about the consequences of long-term use, about the risks to vulnerable populations, and lots more.”
He added: “CBD doesn’t have the same euphoric effects as another cannabinoid you’ve heard of, THC [tetrahydrocannabinol], but it’s also not a risk-free substance. In fact, there are a number of