Earlier this week, Rep. Collin Peterson (D-MN), chairman of the House Agriculture Committee, introduced legislation to include hemp derived CBD in the definition of dietary supplements under the Federal Food, Drug and Cosmetic Act (FD&C Act). The bill, designated at HR5587, enjoys bipartisan support, with Rep. Thomas Massie (R-KY), Rep. James Comer (R-KY) and Rep. Chellie Pingree (D-ME) signing on as cosponsors.
“The last two Farm Bills were landmark successes for hemp, but we are still very early in this process, and growers need regulatory certainty,” said Peterson. “This bill will allow FDA to regulate CBD that comes from hemp as a dietary supplement, providing a pathway forward for hemp-derived products. It would also identify barriers to success for hemp farmers, informing growers and policy makers of the challenges facing this new industry.”
Tension over CBD stems back a number of years
Industry stakeholders have been seeking a way to break the logjam on CBD and hemp extracts ever since the 2014 Farm Bill opened the door a crack for hemp cultivation. In addition, thriving markets have cropped up in states like Colorado that were early adopters of full scale recreational cannabis usage.
The 2018 Farm Bill blew the lid off industrial hemp cultivation by taking the plant off the Schedule One list of controlled substances maintained by the US Drug Enforcement Administration and by specifically allowing hemp cultivation on a state by state basis. But FDA has weighed in by saying that CBD itself cannot be a dietary ingredient for use in foods or supplements because of its prior development as a drug.
In the years since 2014 dozens to hundreds of new companies have brought thousands of hemp/CBD products (no one knows just how many) to market. Most of these products, apparently at least those that specifically claim CBD content on their labels, are technically illegal under FDA’s current interpretation.
Peterson’s bill would get around this conundrum by inserting a specific exemption for CBD in the portions of the Dietary Supplement Health and Education Act that pertain to the so-called ‘exclusionary clause.’ The clause would still be in place, and would apply to everything but CBD.
The American Herbal Products Association has had a working committee on cannabis for a number of years. AHPA President Michael McGuffin said his organization has been attempting to work with FDA on the issue to find the most rational way forward to create a legal pathway to market for products featuring CBD or hemp extracts, which is clearly the will of many members of the US Congress.
AHPA: Regulators should regulate
“Is the Peterson bill the best way to resolve the issue? Of course it’s not,” McGuffin told NutraIngredients-USA.
“The best way is for the regulatory agency to take full responsibility for regulating and for the legislators to take responsibility for legislation. This gets awfully close to regulation by legislation,” he said.
“I appreciate the bipartisan support for this legislation and I share the sponsors’ frustration. But what we really want is for FDA to use its authority to establish a pathway for these products. I understand why FDA says they’ll need three to five years to do that but sometimes we need to encourage those we work with to move faster than they think they can,” McGuffin added.
Legislative fiat seen as having some merit
But attorney Ivan Wasserman, a partner in the firm Amin Talati Wasserman, said in his view it could be a quick and elegant solution to problem. Wasserman, like many attorneys in the industry, said CBD questions are now taking up a majority of his time.
“I am encouraged because it would put CBD on the same footing as any other botanical ingredient used in dietary supplements. It would not impede the other cannabinoids [such as CBG] found in hemp because only CBD has already been studied as a drug,” Wasserman said.
Some observers have questioned whether making a specific exemption for CBD might be the first step onto a slippery slope where dietary supplements could eat into the market share for drugs and discourage drug companies from looking to botanical sources for new therapies. Wasserman said in his view that concern is overblown.
“In any case, the exclusionary clause was not meant to be a public safety provision but was meant to encourage pharmaceutical R&D. I personally think this is such a unique situation, one that we’ve never seen before. I’m not particularly concerned about a slippery slope. And this bill wouldn’t take any arrows out of FDA’s quiver to ensure that CBD products are safe. NDIs, GMPs—all that stuff would still apply,” he said.
FDA’s inaction degrades its authority
Attorney Marc Ullman, of counsel with the firm Rivkin Radler, said he doesn’t agree with creating an exception to legitimize a market that has sprung up because mob of entrepreneurs didn’t agree with how federal legislation is written. Pasting in some sort of quick fix wouldn’t send the right message, he said.
“An entire illegal trade cropped up because people couldn’t be bothered with details like reading federal legislation. And because this market has appeared, does that mean we should just go ahead and legitimize it? That just rewards the scofflaws,” Ullman opined.
“The agency’s grand pronouncements and absolute lack of action on CBD has degraded the agency’s authority. They allowed the marketplace to develop to a point where companies that took the position that they intended to comply with the law [and so held off on CBD product development] are being hurt in the marketplace,” he said.
“It has been a huge regulatory failure,” he concluded.
McGuffin, too, said FDA in its languid action on the issue threatens to give claws to one of the longstanding criticisms of the dietary supplement industry, that it is insufficiently regulated.
“As long as FDA doesn’t act, they are proving that these products are unregulated. They didn’t create this unregulated framework, but their inaction has allowed it to proliferate,” he said.