The Subcommittee on Health Care and Financial Services recently held a hearing titled “Hemp in the Modern World: The Yearslong Wait for FDA Action” to examine the Food and Drug Administration’s lack of regulation of CBD and hemp-derived products.” The oversight committee is presided over by Kentucky Representative James Comer. The hearing marked the first time Congress has formally scrutinized the impact of the FDA’s refusal to develop a regulatory pathway for the sale of ingestible hemp products such as CBD.
Speakers included Minority Witness Gillian L. Schauer, PhD, MPH, Executive Director, Cannabis Regulators Association (CANNRA), US Hemp Roundtable's General Counsel Jonathan S. Miller, Senior Managing Scientist at ToxStrategies Rayetta G. Henderson, President-Elect of Kentucky Narcotic Officers Association Richard A. Badaracco.
Farm Bill
Despite the 2018 Farm Bill legalizing the growth and sale of hemp and hemp-derived products, the FDA claims it does not have the authority to regulate.
“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,” said Council for Responsible Nutrition (CRN) President and CEO Steve Mister in a press release.
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.”
“Whether through the Farm Bill or another priority piece of legislation, a broad regulatory framework is urgently needed to address hemp-derived cannabinoid products,” said Schauer.
“When Congress passed the 2018 Farm Bill, it explicitly legalized the sale of hemp and its derivatives such as CBD,” Miller noted. “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.”
Stakeholders assert the FDA must take action to regulate CBD beyond sending warning letters to create certainty for the industry, support the economy, farmers, and businesses as well to ensure consumer safety.
Safety
Witness testimony highlighted how the lack of FDA regulatory framework for hemp-derived CBD has also contributed to the proliferation of products containing intoxicating or impairing cannabinoids, most prominently delta-8 THC, which are being sold unregulated, sometimes to minors. While none of the witnesses expressed support for the criminalization of these products, they agreed that strict regulations are needed for safety and to keep them out of the hands of minors.
New pathway
Last January, FDA’s Principal Deputy Commissioner Janet Woodcock, MD, said 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,” pointing to the lack of information currently available on CBD safety.
However, many note that other countries have been able to establish safe usage levels.
“Let's look at every other government. Let's look at the UK, let's look at Canada. For supplements and foods, they established a daily exposure level and that's kept their population safe, there are no adverse events. That’s the role of this public health agency, so if those other governments can do it, why can't FDA?” Stated Natural Product Association’s President and CEO, Daniel Fabricant, PhD, and NPA’s Director of Government Relations, Kyle Turk.
If we're looking at the bigger public health issue, which is exposure through foods and dietary supplements, that's really the question that Americans deserve to have answered first and FDA has ample authority to do that–yesterday.”
Request for Information
House Energy and Commerce Committee Chair Cathy McMorris Rodgers (R-WA) and Ranking Member Frank Pallone, Jr., (D-NJ), along with Senate Health, Education, Labor, and Pensions Committee Chair Bernie Sanders (I-VT) and Ranking Member Bill Cassidy, M.D. (R-LA), announced a bicameral Request for Information (RFI) to subject matter experts and stakeholders regarding FDA’s regulation of CBD.
“Since hemp was descheduled five years ago, consumers, manufacturers, and policymakers have sought clarity regarding the legal status of CBD,” the RFI stated. “Farmers, food and beverage groups, and state regulators have shared their policy priorities with Congress. However, questions remain about the best way to provide a legal pathway to market for CBD products.”
Paige Figi, Executive Director of the Coalition for Access Now, a 501(c)4, to help provide families relief to their children via CBD, told us that the RFI is the next step and she’s encouraged that things are moving in the right direction.
“I've never seen such an appetite in Congress on the Hill to get something done. We've never quite been this far ahead and the industry is organizing well together,” said Figi.
Miller shared a similar sentiment: "The unity within the industry is remarkable and telling: Our shared voice will resonate with Congress and help us turn this opportunity into meaningful progress for hemp farmers and product consumers.”
Some of the RFI’s topics and questions include:
- Comments on the concerns FDA has raised with regard to regulating most CBD products through existing pathways (i.e., conventional foods, dietary supplements, and cosmetics), and FDA’s view that there is a need for a new regulatory pathway for CBD products. If existing regulatory pathways are sufficient for regulating CBD products, please explain how these existing pathways can be used to address the concerns raised by FDA, as appropriate.
- How the absence of federal regulation over CBD created a market for intoxicating, synthetically-produced compounds, such as Delta-8 THC, THC-O, THC-B, HHC-P and others?
- How should a new framework for CBD products balance consumer safety with consumer access?
- What precedent exists in foods, dietary supplements, tobacco, and cosmetics for requirements of labeling to present risks to special populations in labeling (e.g., children, pregnant and lactating women, consumers taking certain drugs, etc.)? What amount and type of evidence has been required to support such requirements?
The full RFI can be accessed here. Responses to the RFI can be submitted to CBD@mail.house.gov and CBD@help.senate.gov with a deadline of August 18, 2023.
