Washington, D.C.—Four trade associations representing the natural products and dietary supplements industries sent Congress a letter on Tuesday, asking them to take legislative action to clarify the legal status of hemp-derived CBD dietary supplements. The trade associations included the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA), the Council for Responsible Nutrition (CRN), and the United Natural Products Alliance (UNPA).
The letter states that action is urgent, citing the strong consumer interest in CBD, growth in product and sales, and need for clarity among consumers, retailers, and manufacturers regarding the legal status of these products. It adds that, as hemp production is rising largely in response to CBD demand, U.S. farmers need to know if there’s a legal market for hemp.
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Steve Mister, President and CEO of CRN, told WholeFoods that going to Congress is “part of a multi-pronged approach, with the goal being to create a legal pathway to market for CBD. We are continuing the dialogue with FDA—we’ve sent them written comments, we’ve appeared in public meetings, we’ve had private meetings—but we’re concerned. The Farm Bill passed in December. 10 months have gone by and we are no closer to getting a legal pathway to market.” Both Mister and the letter brought up the comment made by Scott Gottlieb, M.D., then-Commissioner of FDA, in which he suggested that even an expedited rulemaking process would take three to five years. “That’s simply unacceptable,” Mister said. “There is a several hundred million dollar marketplace for ingestible products that contain CBD, but the agency gets up to the podium and says it’s illegal, but isn’t doing much to enforce that? If we have to go to Congress, well, maybe they’ll put pressure on the agency, or simply legislate it.”
The letter urges Congress to pass legislation clarifying that CBD derived from the hemp plant is a lawful dietary ingredient if it meets established product safety and quality criteria. The letter notes that this would require a limited waiver of certain sections of the Food, Drug, and Cosmetic Act (FDCA), but that the CBD would be required to fully comply with all other provisions of the FDCA.
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The letter ended by urging Congress to include in the Fiscal Year 2020 budget “substantial new resources” to enable effective FDA oversight of CBD, including funding for the timely review of new dietary ingredient notifications.
Mister said that CRN will be on the Hill today and Friday, and hope to get a sense of Congress’ response at that time. With regard to member concerns, he said that CRN vetted all positions laid out in the letter through their board.
Meanwhile, as reported by Marijuana Moment, a group of six senators sent a letter to FDA on September 23, calling on the agency to “urgently clarify and implement regulations for CBD derived from hemp.” The senators—Richard Blumenthal (D-CT), Patrick Leahy (D-VT), Jon Tester (D-MT), Tammy Duckworth (D-IL), Charles Schumer (D-NY), and Kirsten Gillibrand (D-NY)—wrote that “consumers still lack answers to questions about the potential risks, including adverse side effects and drug interactions, associated with CBD. Consumers rely on the FDA to conduct timely and appropriate oversight of new and emerging ingredients, and guidance from the FDA would also help manufacturers to develop safer, more effective, and more credible products for consumer use… Your efforts to date have been woefully inadequate. Within 90 days please provide our offices with an outline of your agency’s current plans for a specific regulatory framework related to CBD along with a timeline for when comprehensive enforcement policies will be finalized and implemented.”
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Mister ended on a hopeful note. With regard to his comments made in June at the Legal, Regulatory and Compliance Forum on Dietary Supplements, when he said “This is the ingredient that either proves that DSHEA works, or it could be the downfall of DSHEA,” Mister said “Sure hope it’ll be the former. I’m still very optimistic that it’ll demonstrate that DSHEA does work. We think that the framework that DSHEA laid out gives FDA the answer that it wants. Every single product that comes to market would be considered a new ingredient; CBD wasn’t on the market prior to 1994, I don’t think anybody’s arguing that. DSHEA requires a filed notification demonstrating that the product is reasonably expected to be safe. DSHEA is ideally suited to deal with something like CBD. If FDA enforces this and other safeguards, like GMP requirements and adverse event reporting, it will create a regulated framework for CBD.”