Creating a legal exception for CBD supplements, short of full safety data, could set a bad precedent, says FDA at CRN Conference

November 8, 2019

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) of 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 known health risks, including, among other things, potential liver toxicity and drug interactions. We’ve also seen animal studies indicating potential risk to the male reproductive system.”

Until FDA feels it has solid safety data, “it’s important to remember that there are no special rules for CBD,” Schiller said. FDA has taken the position that CBD is not a legal dietary ingredient for food and supplements, meaning that “it’s unlawful to sell a food or a dietary supplement with CBD in interstate commerce,” he added.

In this context, Schiller said, “We look at an FDA-regulated product containing CBD the same as we would look at an FDA-regulated product containing any other substances. We apply the same tools and authorities and statutory provisions. At FDA, we don’t have one set of rules for cannabis-derived substances and another set of rules for other substances. We don’t approach CBD or other cannabis-derived substances with any sort of animus or imposing new burdens.”

“If we don’t think that we’ll have the data to say that some level of CBD can be safely added to a food or a dietary supplement, then we wouldn’t want to create an exception for CBD. If, for example, we wouldn’t allow a new food preservative or flavoring substance to be added to foods that have the same safety data as CBD, well, why would we apply a different rule for CBD?” he asked.

 

Concerns about the Market

Schiller also talked about questionable products that FDA does not authorize but currently sees in the market.

“Many of the manufacturers entering this space lack experience with FDA or DSHEA [the Dietary Supplement Health and Education Act of 1994], and we have serious concern about issues like harmful contaminants such as pesticides, heavy metals, or other drugs like THC. We’re also seeing some egregiously irresponsible behavior, like marketing CBD products for use by infants, or promoting them to treat serious conditions like cancer or opioid use disorder. It’s this kind of conduct that puts the public at risk [and that] are making it a significant enforcement priority at FDA.”

 

FDA Remains Cautious

Schiller said FDA is concerned about making CBD legal given the agency’s current worries about both safety and the fast-growing marketplace containing some irresponsible actors. What kind of message it would send about the agency’s regulatory actions if it were to authorize CBD now, in light of these concerns, he asked?

“We’re unable to conclude that CBD is safe for use in foods or dietary supplements, and yet, if we were to make an exception to allow for such uses, what would that mean for the next substance to come along with similar unknown safety risks?” he asked.

Later, he added, “If we were to create some kind of exception for CBD, what would that do to our ability to identify and address these kinds of violations? By some estimates, the CBD market has already grown to roughly half the size of the entire dietary supplement market at the time DSHEA was passed. Think about that.”

FDA authorization could also spur more questionable companies to enter the market, he said. “If we were to create some kind of exception for CBD, how many new products will come on the market—and manufacturers without a history of complying with basic requirements like good manufacturing practices or truthful labeling? Do we at FDA have the tools and the resources we would need to identify all the potential violations we might see, let alone to address them? And what would that mean for our existing work?”

For now, said Schiller, “The CBD market is growing rapidly, and I’m concerned that in many cases, the excitement is outpacing capability.”

FDA is also concerned that the public would read a CBD exception as an endorsement of the ingredient by the agency, Schiller said. "[I]f we were to—we have to go through the notice-and-comment rulemaking to create an exception to this provision, to this exclusion—if we were to do that and come out with a big new rule allowing CBD in supplements...then what is the public perception of that? I think it will inevitably be perceived as an FDA endorsement of the safety of the product. I think just consumer perceptions will necessarily fall that way. And if we haven’t come to a conclusion that it can be safely used in a dietary supplement, why would we go through that process and create that public perception if that’s not where we are? And frankly, this is a space where we don’t need more consumer confusion."

Schiller said FDA is grappling with these issues as it continues actively deciding how to handle CBD’s regulatory status. “We plan to report on our progress soon,” he said.

“As we continue to work as rapidly as possible to figure out how to address this popular ingredient, which until very recently was a controlled substance, it’s important to remember that there no special rules for CBD,” he said.