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.
Related: 14% of Americans Use CBD, Gallup Finds Gottlieb Again Suggests Legislation for CBD, Notes PrecedentSteve Mister, President and CEO of CRN, toldWholeFoodsthat 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.
Related: FDA Cannabis/CBD Public Hearing: “FDA Does Not Have the Luxury Of Time” Arrest of CBD-Carrying Great-Grandma Sparks DiscussionThe 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."