Several trade associations expressed support for a bill introduced last month in the U.S. House of Representatives that would allow CBD to be marketed in dietary supplements and conventional food, but they acknowledged challenges getting a standalone bill passed in Congress.
In interviews with Natural Products Insider, some of the trade groups also supported introduction of broad legislation that addresses virtually all cannabinoids in the hemp plant, not just CBD. Such legislation would allow supplement companies to market other hemp-based cannabinoids that have promising health benefits, such as CBG (cannabigerol), even if FDA determined those cannabinoids were first authorized for investigation as a new drug.
Rep. Collin Peterson, Democrat from Minnesota and chairman of the House Agriculture Committee, introduced a bill that would include hemp-derived CBD in the definition of a dietary supplement, overcoming a current hurdle facing the industry: FDA’s longstanding opinion that CBD cannot be marketed in a food or supplement under the Federal Food, Drug & Cosmetic Act (FDCA) because it was first studied as a drug by GW Pharmaceuticals plc, whose CBD medicine Epidiolex was approved in 2018 by FDA to treat seizures associated with two rare and severe forms of epilepsy.
Under Section 201(ff)(3)(B)(ii) of the FDCA, an article doesn’t meet the definition of a dietary supplement if it was first “authorized for investigation as a new drug” and the subject of “substantial clinical investigations” that were publicized. FDA has determined CBD meets the above criteria.
Jonathan Miller, general counsel to the U.S. Hemp Roundtable, a coalition of dozens of companies and organizations, said his organization “strongly” supports Peterson’s bill.
“It is right to the point, targeted and would ensure that the FDA started to regulate the sale of hemp-derived CBD products,” he said in an interview. “We’re glad it was introduced and encouraged by the bipartisan co-sponsorship.”
Patrick Delaney, communications director for the House Agriculture Committee, said in an email that H.B. 5587 “would create a pathway for hemp-derived CBD to be used for both dietary supplements and food additives.”
“However, hemp-derived CBD would still be subject to the existing FDA regulatory structures for either dietary supplements or food additives,” he added. “So the bill is not a blanket approval, but would allow FDA to regulate hemp-derived CBD via existing regulatory pathways.”
Though Miller expressed reservations about H.B. 5587 getting passed by Congress as a standalone bill, he is hopeful the legislation would be attached to a piece of must-pass legislation. The bill was referred to the House Committee on Energy and Commerce, which has jurisdiction over FDA.
Bill addresses FDA hesitation
FDA has been considering whether to use its discretion under the FDCA to allow CBD in conventional food and supplements despite its position that GW Pharmaceuticals first conducted clinical trials on the compound.
The agency has suggested it won’t commit to a potentially lengthy rulemaking if its safety concerns are not addressed.
“The best thing that could happen is the FDA does its job and starts the pathway toward regulation,” Miller said in an interview. “But if they don’t, then we’re going to be really encouraging Congress to pressure them to act.”
Patrick McCarthy, CEO of ValidCare, a market intelligence and research platform for the hemp-derived product industry, said Congress has been advised that FDA has safety concerns about CBD.
“It wouldn’t be wise to legislate without the safety data,” he said in an interview.
The CBD legislation is “not a perfect solution," said Michael McGuffin, president of the American Herbal Products Association (AHPA), which has been involved with cannabis issues for about a decade.
But he said his organization would not oppose the bill.
“Is it a solution that we accept if we stack all these things together?” McGuffin asked in an interview. “One, we have a mutual commitment to ensuring public safety. Two, [CBD] products are proliferating in the marketplace. Three, FDA hasn’t shown us where the door is. And we still want to protect public safety with products in the marketplace, then maybe we’re forced to find this as the next best solution.”
McGuffin concluded: “What we really want is for the Food and Drug Administration to take the responsibility for addressing safety of food, supplements and their ingredients, and this [bill] goes around them.”
The leader of another trade organization said H.B. 5587 is “generally moving in the right direction.”
“It’s looking more and more apparent to CRN that FDA is not going to move on its own, and that it’s going to need a nudge from Congress,” said Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN), in an interview. "And we agree that the best way to go about doing that is to create an exception from” the drug-related exclusionary provision in the FDCA.
Other cannabinoids matter
But Mister noted Peterson’s legislation “appears to be specific to CBD,” and he cited the potential benefits of other cannabinoids that are starting to be marketed.
“We ought to take care of all of the cannabinoids, terpenes, resins, etc. that are in hemp at once and make it clear that hemp and all of its constituents with the exception of THC are not subject to the drug exclusion,” he explained.
Asked whether such a bill would face resistance from the pharmaceutical industry and was too broad a request, Mister responded: “If we don’t deal with it now, we will be sorry … we need to deal with all of these cannabinoids at once.”
Stephen Schultz, vice president of investor relations with GW Pharmaceuticals, said companies putting CBD in conventional foods or dietary supplements would still need to meet all the requirements of the FDCA, including demonstrating safety, if Congress passed H.B. 5587.
"GW continues to believe that as a matter of public health only the FDA should determine whether there are sufficient safety data to support the use of CBD in foods and supplements," Schultz said in an emailed statement after this initial article was published. "The onus is on industry to provide that data so consumers can be assured mass-marketed CBD products are safe. It is also important to consider that CBD consumer products are typically taken with little-to-no physician oversight and the unknown effects of cumulative exposure from daily, multiple sources of CBD–as well as potential drug interactions–could risk public health."
Loren Israelsen is president of the United Natural Products Alliance (UNPA) and an instrumental figure in the negotiations that led to passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
He described Peterson’s bill as “very clean.”
“It cuts to the chase and clarifies the situation with little ambiguity,” Israelsen said in an interview.
But he also expressed support for a “comprehensive solution to all constituents in hemp.” Should FDA determine other cannabinoids were first studied as drugs and consequently excluded from the definition of a dietary supplement, Israelsen is among those in favor of broad legislation that would create an exception for those other cannabinoids.
“Congress doesn’t want to revisit [the issue later on], nor does FDA, nor do we,” he explained. “The obvious hard problem is it makes it a much bigger ask to make it comprehensive.”
“Everybody is aware that there is active research going on with a number of other cannabinoids,” Israelsen added. “This is not a theoretical what-if. This is the reality.”
Whether the drug-related exclusionary clause has been triggered for other cannabinoids and “how many times” remains “unknown,” he said.
In response to a request for comment, an FDA spokesperson said the agency could not share information on any cannabinoids that are or have been subject to an investigational new drug (IND) application.
Finally, GW Pharmaceuticals underscored the importance of preserving incentives to investing in research of new drugs.
"GW continues to support rigorous clinical research to unlock the potential of the cannabis plant and a clear differentiation between CBD-containing medicines and mass-marketed CBD consumer products," Schultz said. "A framework that waives the IND bar should also rebalance research incentives and include policies to ensure rigorous medical research of cannabis and its derivative products continues and expands."