The July 27th hearing was called by the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services.
U.S. lawmakers criticized FDA for failing to make progress on creating a legal pathway for hemp-derived cannabinoids, including cannabidiol (CBD), in dietary supplements and food during a congressional hearing held yesterday, July 27. The hearing “was the first time Congress has formally scrutinized the impact of the U.S. Food and Drug Administration’s (FDA) failure to develop a regulatory pathway for the sale of ingestible hemp products such as CBD,” stated the group U.S. Hemp Roundtable, whose general counsel Jonathan Miller testified at the hearing.
The hearing was called by the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services. Titled the “Hemp in the Modern World: The Yearslong Wait for FDA Action,” the hearing heard oral testimony from these key witnesses: Jonathan S. Miller, general counsel, U.S. Hemp Roundtable; Rayetta G. Henderson, PhD, senior managing scientist, ToxStrategies LLC; Richard A. Badaracco, president-elect of the Kentucky Narcotic Officers Association and a retired assistant special agent at the U.S. Drug Enforcement Administration; and Gillian L. Schauer, PhD, MPH, executive director, Cannabis Regulators Association.
Witnesses, as well as lawmakers, largely criticized FDA for not yet having established a regulatory pathway for hemp/CBD dietary supplement and food products. Critics of FDA believe the agency already has the regulatory power it needs to legalize hemp cannabinoids in food and supplements. FDA, however, has argued that an entirely new legislative route for CBD needs to be created. This January, a statement from FDA’s Principal Deputy Commissioner Janet Woodcock, MD, declared that “a new regulatory pathway for CBD is needed that balances individuals’ desire for access to CBD products with the regulatory oversight needed to manage risks.”
As Nutritional Outlook Editor Sebastian Krawiec previously reported, “The fear for industry is that devising an alternative regulatory pathway for CBD and other cannabinoids would give FDA new and far-reaching authority,” including requiring premarket approval (which isn’t required for supplements) and additional testing requirements.
FDA says its reason for demanding a new regulatory framework for CBD is that the agency believes there is not enough information currently available on the safety of CBD products for human consumption. It has also stated that CBD cannot be a legal dietary ingredient because the ingredient runs afoul of the drug preclusion clause of the Federal Food, Drug, & Cosmetic Act (FD&C Act), which precludes ingredients first publicly studied as drugs to then be sold in supplements.
Those who disagree with FDA point out that other countries have been able to establish safe usage levels for CBD products, legalizing their use. Moreover, as Krawiec pointed out in Nutritional Outlook’s article, industry-leading CBD brands and researchers have already shared data their own toxicological safety data on CBD with FDA, information that the agency has had in hand for years.
During the hearing, Rayetta of ToxStrategies LLC said in testimony, “Based on my experience performing similar evaluations, the data available are sufficient for conducting a safety assessment of CBD following the same principles that we would apply for any ingredient proposed for use in foods or supplements.”
Meanwhile, many lawmakers and representatives of the hemp industry have pointed out that by failing to create a legal pathway for hemp/cannabidiol supplements, FDA has enabled an unregulated market in which there are “products containing intoxicating or impairing cannabinoids, most prominently delta-8 THC, which are being sold unregulated, sometimes to minors,” creating risks for consumers, as U.S. Hemp Roundtable’s statement said in a press release reporting on the July 27 hearing.
It added, “Hearing witnesses and members of Congress shared the same sentiments: 1) a regulatory framework for hemp-derived cannabinoids is urgently needed, 2) FDA has the existing data, tools, expertise, and authority to regulate hemp-derived cannabinoids, and 3) a continued lack of FDA regulations for products containing hemp-derived cannabinoids poses a major consumer health and safety issue.”
During the hearing, some members of the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services said FDA should move ahead in creating news legislation to legalize hemp cannabinoids while others said the agency already has existing authority to do so, such as under the 2018 Farm Bill.
“The pathway already exists,” said Representative Lisa McClain (R–MI), chair of the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services. “Congress spoke in 2018. The FDA just needs to do the job that the American taxpayer is paying them for, and if they can’t do their job, maybe we should stop funding them, or [fund] them at reduced levels.”
Meanwhile, Rep. Katie Porter (D–CA), said, “We should all be able to agree that the federal government needs to regulate hemp-derived products in a way that protects our constituents while also making safe products available to them. Given the bipartisan interest, members of Congress should have no problem rolling up our sleeves…and getting to work to establish the regulatory pathway that the FDA says it needs.”
The overall message from witnesses and lawmakers at the hearing was that FDA needs to move quickly to initiate a regulatory framework for hemp cannabinoids. Witness Schauer of the Cannabis Regulators Association said, “Whether through the Farm Bill or another priority piece of legislation, a broad regulatory framework is urgently needed to address hemp-derived cannabinoid products.”
Many made clear their criticism of FDA’s actions around hemp cannabinoids. “FDA has simply not been transparent with the industry stakeholders or Congress in what scientific studies it relies on and often moves the goal post for researchers attempting to satisfy the FDA’s requirements through rigorous studies,” said Rep. James Comer (R–KY), U.S. House Oversight Chairman, at the hearing. “So even though we have more and more data available to regulators to make appropriate decisions about CBD in the marketplace, the FDA has taken no meaningful action to provide clear guidance and certainty in the market, refusing to regulate CBD products under existing lawful pathways. Without FDA regulations, the good-faith producers of these products are left with no path forward, and consumers are left in the dark.”
U.S. Hemp Roundtable’s Miller added: “There are abundant consumer safeguards encompassed in the Federal Food, Drug, and Cosmetic Act that would be applied to CBD products sold as dietary supplements.” Supplement manufacturers aren’t allowed to sell mislabeled or adulterated products and must follow regulations for manufacturing, labeling, and reporting serious adverse events, for instance. Miller added that FDA could also require childproof packaging to assuage concerns of potential use by children.
Leaders of supplement industry associations also submitted written testimony for the hearing.
Comments from the Natural Products Association (NPA; Washington, DC), included: “Instead of collaborating with Congress and industry to use its existing legislative authority wisely, FDA has embarked on the pursuit of a new regulatory empire via a ‘center’ for cannabis/hemp. Based on what happened with the Center for Tobacco Products (CTP) at FDA, another new center will be yet another huge expense, likely costing the taxpayer hundreds of millions of dollars, more delays, and, as we’ve seen with CTP, no demonstrable functionality as a regulator.”
The Council for Responsible Nutrition (CRN; Washington, DC) stated in a press release that its comments focus on “asking that Congress demand FDA complete the work Congress directed the agency to do under the 2018 Farm Bill by permitting CBD and other hemp-derived cannabinoids to be lawfully marketed as dietary supplements using the appropriate safeguards found in the existing law.”
In CRN’s comments, the association concluded, “In the five years since Congress enacted the 2018 Farm Bill, the dietary supplement market for products containing CBD has exploded. While FDA dithers on how to regulate this marketplace, consumers are exposed to a wide range of products—some well-made and accurately labeled; and others that are mislabeled, contain too much, too little, or even no CBD; ones containing contaminants, or intoxicants like THC or delta-8; or that impermissibly claim to treat a range of diseases. It’s too late to return the proverbial horse to the barn; consumers deserve to have a CBD marketplace that is regulated and predictable. Allowing CBD to be marketed in dietary supplements would address these needs. Congress should enact H.R. 1629 and demand that FDA implement it.” (H.R. 1629 refers to the “Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2023,” reintroduced this year, which would direct FDA to deem CBD legal for use in supplements.)