Washington D.C.—As WholeFoods magazine previously reported, on July 27 experts testified during a hearing on hemp and CBD before the House Oversight and Accountability Committee’s Subcommittee on Health Care and Financial Services. Titled Hemp in the Modern World: The Years long Wait for FDA Action, this hearing is the first time Congress has formally scrutinize the impact of FDA’s failure to develop a regulatory pathway for the sale of ingestible hemp products such as CBD, according to the U.S. Hemp Roundtable.
(Background: The Latest in the Push for Regulation of Hemp Products Such as CBD)
The need for hemp-derived cannabinoids to be lawfully marketed as dietary supplements
Experts explained why FDA has the existing data, tools, expertise and authority to regulate hemp-derived cannabinoids. A continued lack of FDA regulations for products containing hemp-derived cannabinoids poses a major consumer health and safety issue, experts caution.
“Lack of a federal framework has led to the proliferation of unregulated products, some of which raise significant quality, safety, and other consumer protection concerns,” said U.S. Hemp Roundtable General Counsel, Jonathan Miller. Read Miller’s full written testimony here: 2023-Hearing-Packet.pdf (hempsupporter.com).
The Council for Responsible Nutrition (CRN) provided written testimony asking Congress to "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."
CRN, in response to FDA’s conclusion that a new regulatory pathway for CBD is needed, pointed out that the current regulatory framework for dietary supplements "provides ample tools by which FDA can mitigate risks and protect consumers, while allowing access to safe botanicals, like CBD. Other possible safeguards that FDA imagines for a new category of cannabis products could be achieved under the existing framework."
The Natural Products Association (NPA) shared its official testimony for the record about the FDA’s
"glaring lack of progress on any meaningful path towards regulation of CBD." NPA wrote: "FDA can today, under current authorities, can set a daily consumption level (which would address the major public health concerns) in foods and dietary supplements. Establishment of such a level would trigger other authorities dealing with labeling and product quality through good manufacturing practices (cGMP), which the agency can use to effectively regulate the marketplace and inspect facilities and analyze products. FDA can do this either through enforcement discretion (which has precedence for dietary supplements as recently as 2022 with N-Acetyl Cysteine) or through notice-and-comment rulemaking (an option which was written into statute in 1994 but has never been used by FDA). Once this pathway is established it would be viable for the other cannabinoids."
CRN President and CEO Steve Mister explained: “The FDA is downplaying, underestimating, and misrepresenting its enforcement capabilities and consumer protection tools it already has for dietary supplements as a justification for establishing new staff and resources within the FDA, and a regulatory category that undermines and ignores the existing structure. Creation of this new framework would require substantial funding requests from Congress to set up and staff it; or, if the FDA instead decided to seek user fees on these products, doing so could ultimately raise costs for consumers. In the meantime, consumers are left to navigate the CBD marketplace without any guardrails imposed on these products, when a viable framework for dietary supplements already exists.”
Miller noted: “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. For example, the law precludes manufacturers and distributors from selling mislabeled or adulterated products and it requires manufacture and sale of products consistent with good manufacturing product standards. The law also requires reporting of serious adverse events, and it mandates strict labeling, including if FDA desires, warnings against the use of products by children. Finally, the FDA with the Consumer Product Safety Commission could require child-proof packaging,”
Safety of CBD
As WholeFoods has reported, the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition (CFSAN) published its review the oral toxicity of cannabidiol (CBD). The authors of the review stated: "The toxicological profile of CBD raises safety concerns, especially for long term consumption by the general population."
NPA weighed in on the review when it was released. Daniel Fabricant, Ph.D., NPA President and CEO, said: “Using drug standards to conduct a ‘supplement study’ is at the very least disingenuous and at the worst very harmful for the foundering and rudderless regulatory process on CBD. Instead of using actual dietary supplement data and research like the data we supplied to the agency in our citizen’s petition, the FDA instead chose to use drug data to draw conclusions that are three times the dose of the CBD drug Epidiolex. This is extremely troubling, confusing, and sets us back even further on one of our top priorities for the past several years, which is meaningful progress on a regulatory path for something that’s ubiquitous in the market.”
Also weighing in on the topic of science and safety at the hearing, U.S. House Oversight Chairman, Rep. James Comer (R-KY) said: “FDA simply has not been transparent with the industry stakeholders or Congress in what scientific studies relies on and often moves the goal post for researchers attempting to satisfy the FDA’s requirements through rigorous studies. 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.”
FDA has also expressed concerns about CBD content in foods. To that, NPA counters: "FDA has also argued against CBD in foods, due to potential of abuse or overeating. However, FDA has never made a similar assertion about other foods or ingredients (i.e. sodium, corn syrup) used under the Reference Amounts Customarily Consumed (RACC) for foods and beverages. FDA has not presented any data to support their statements that exposure and potential for abuse would be greater in foods with CBD than any other food ingredient."
Congress must direct FDA to act
Concluding its remarks, NPA wrote: "Congress must direct FDA to use this authority, removing any drug preclusion, as well as other existing authorities for natural products to establish a safe daily amount as a food or supplement. This will establish the appropriate balance. Some are concerned that FDA would strike an unnecessarily low daily amount under such an approach. Such a level can be reviewed via Oversight and Investigation as appropriate going forward. Additionally, a level of even 40 mg a day which is approximately half of what was rendered in Canada would be preferred to the current status quo which is 0 mg a day and a regulator refusing to inspect facilities and test products to ensure Americans are safe."
