Bill introduced to add CBD to DSHEA’s supplement definitions

14-Jan-2020 - Last updated on 14-Jan-2020 at 17:55 GMT

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Building on a regulatory foundation already laid for hemp ingredients, Rep. Collin Peterson (D-MN) has proposed a bill that would include CBD under the definition of dietary supplements found in DSHEA.

Peterson, who is the chairman of the House Agriculture Committee, introduced the legislation yesterday 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.

Providing legal pathway

“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.”

The bill would also require a study and report from the US Department of Agriculture, which oversees the production of hemp, on the regulatory and market barriers for farmers engaged in hemp production.

Peterson represents a rural district that covers most of western Minnesota and is a farmer himself. As one of the movers and shakers behind the 2018 Farm Bill, he said at the time he was interested in provided new markets and commodities for hard pressed farmers.

“I may grow some hemp on my farm. I'm looking at it," Peterson told Minnesota Public Radio in late 2018. "There's a big market for this stuff that we've been ceding to Canada and other places.”

The bill amends the Dietary Supplement Health and Education Act by carving out a specific exemption for hemp-derived CBD in the so-called ‘exclusionary clause’ found in that legislation. This portion of DSHEA states that if “an article” was investigated as a drug prior to coming to market as a dietary supplement or as part of a food, then a drug it must remain and the other uses are precluded. Rep. Petersen’s bill adds the phrase ‘“(other than hemp-derived cannabidiol or a hemp-derived cannabidiol containing substance)” after “an article” in this portion of the legislation.

Collaborators on bill

Attorney Tami Wahl and consultant Mike Greene collaborated with Rep. Peterson’s office in work on the legislation. Greene, who prior to starting his own consulting firm spent almost 20 years at the Council for Responsible Nutrition, where he was senior vice president for government relations, said the bill would help make good on the promise that seemed to have been implied in the 2018 Farm Bill.

“I think the sponsors of that legislation thought CBD would be legal after the Farm Bill passed. My reading of this new bill is that it is making good on that promise,” Greene told NutraIngredients-USA.

Wahl, who runs her own law firm in Washington, DC and who previously was special counsel to the American Herbal Products Association, said the legislation will help provide clarity for the many stakeholders in the market.

“I come from a rural community in Minnesota, so I understand the potential for this crop and the excitement around it,” she said.

“The purpose of this legislation was to be true to the intent of the Farm Bill and to provide the regulatory certainty that everyone who has an interest in this ingredient needs. Looking back over the last growth cycle there was concern expressed by some of the farmers about whether they’d have end markets for their crop,” Wahl added.

FDA would be free to regulate ‘chaotic’ market

Greene said that while the new bill would obviate the exclusionary clause, it wouldn’t prevent FDA from doing the other things that might be necessary, such as requiring New Dietary Ingredient Notifications where appropriate. And Wahl said it could help FDA to start doing some of the things that aren’t getting done now.

“We’ve had a handful of warning letters on CBD that pertain to things like egregious claims. But with regulatory certainty FDA could enforce on a lot of other things, like GMP compliance, facility registrations, labeling issues and so forth,” she said.

“What this would help do is to resolve some of the chaos in the market,” Greene said. “CBD is everywhere.”