The CBD quandary facing the dietary supplement industry will not be solved this year.
Despite lobbying from several industry groups, a bill to fund some federal agencies—including FDA—and avert a government shutdown does not include language that would create a legal pathway for hemp-based CBD in dietary supplements.
Several industry trade groups recently wrote to Congress, urging lawmakers to create a legal pathway for CBD in supplements in response to FDA’s long-held position that the compound cannot be marketed in dietary supplements because it was first studied as a drug.
But the spending “bill did not include the legislative change we sought to make CBD a legal dietary ingredient in dietary supplements,” Patricia Knight and Peter Reinecke, senior political advisors to the United Natural Products Alliance (UNPA), wrote in a memo released late Monday.
In an Oct. 8 letter to Congress, the American Herbal Products Association (AHPA), Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA) and UNPA said any CBD products allowed to be marketed in supplements would need to meet the definition of hemp in the 2018 Farm Bill and comply with applicable requirements of the Federal Food, Drug & Cosmetic Act and FDA’s regulations related to dietary supplements, including requirements for new dietary ingredients (NDIs). The safety-related, premarket NDI notification requirement is part of the 25-year-old Dietary Supplement Health and Education Act (DSHEA).
“We are continuing to assess this situation and how it evolved,” Knight and Reinecke noted in the memo. “Preliminary reports we have received from the Hill indicate that FDA was not supportive of the industry’s language recommending an NDI pathway for CBD dietary supplements. In particular, the agency insists on evidence that would support a dosage level as safe.”
A bill passed in June in the House of Representatives, which drew the support of the Natural Products Association (NPA), directed FDA to establish a safe level of CBD for consumers to use. However, that language was not incorporated in a spending package that must be passed by Congress and signed by President Donald Trump in the coming days to avoid a government shutdown.
Instead, legislation to fund FDA and USDA incorporates report language earmarking $2 million for research, policy evaluation, market surveillance, issuance of an enforcement discretion policy and regulatory activities related to CBD-containing products under FDA’s jurisdiction that meet the definition of hemp in the 2018 Farm Bill.
The report language also directs FDA to provide a report to House and Senate appropriations committees within 60 days of the legislation’s enactment related to its “progress toward obtaining and analyzing data to help determine a policy of enforcement discretion and the process in which CBD meeting the definition of hemp will be evaluated for use in products.”
Congress further directs FDA to assess, through a sampling study, the CBD market to determine the extent to which products are adulterated or mislabeled and report to lawmakers within 180 days of the bill’s enactment.
“While providing funding for testing is a positive first step, unfortunately, today’s action falls short of what is needed to protect consumers,” said Daniel Fabricant, Ph.D., president and CEO of NPA, in a press release Monday. “The future of the U.S. hemp industry and the farmers and producers who provide it are directly tied to smart regulations for CBD, which includes FDA establishing a safe level of consumption so consumers are protected.”
David Spangler, senior vice president of legal, government affairs and policy with CHPA, said he was pleased the spending bill includes funds to support FDA’s work around hemp-derived CBD.
“CHPA has been asking very explicitly—including in our citizen petition—for FDA to accelerate their work in this area and the package similarly encourages FDA to speed up the establishment of a policy framework for CBD-containing products to enter [the] market legally,” he said in an emailed statement.
But the industry will be heading into 2020 without a clear pathway forward for CBD in dietary supplements amid growing concerns expressed by FDA about the compound’s safety profile.
“The FDA is concerned that people may mistakenly believe that trying CBD ‘can’t hurt,’” the agency noted in a recent consumer update. “The agency wants to be clear that we have seen only limited data about CBD’s safety, and these data point to real risks that need to be considered.”
FDA also has asserted CBD cannot be added to conventional food because it was first studied as a drug, yet CBD has profilerated in food and dietary supplements sold in the United States—a trend partly fueled by the 2018 Farm Bill, which removed hemp from the Controlled Substances Act.
"Growth aside, Americans buying CBD in today's huge market deserve the protection and consistency that federal regulation brings," the Grocery Manufacturers Association (GMA) wrote in a recent blog. "The fact that they believe they already have it shows that the situation is urgent and requires swift action."