A pair of Republican congressmen is demanding answers from the Food and Drug Administration (FDA) over the continued lack of regulations for CBD as food items and dietary supplements.
Reps. Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf on Monday, expressing concerns about the protracted timeline for CBD rulemaking since the hemp-derived cannabinoid was federally legalized under the 2018 Farm Bill and the resulting “significant marketplace disruptions and regulatory uncertainly.”
The lawmakers said that they understand FDA is continuing to collect scientific data on the safety of CBD in the food supply—and that it intends to work with the agency’s independent non-profit Reagan-Udall Foundation to evaluate regulatory processes overall—but they want FDA to answer to Congress in the interim.
“The United States currently has a robust but largely unregulated CBD market, which leads to an unsafe marketplace for consumers,” they wrote. “Consumer products that contain CBD—such as dietary supplements, food, and beverages—are currently sold across the country under a patchwork of state laws and regulations that have been developed and promulgated in light of FDA’s inaction.”
“This has even led to multiple cases of children purchasing over-the-counter CBD gummies with unsafe levels of delta-8 THC and suffering harm as a result,” the letter says. “This is due to the FDA’s failure to regulate and enforce statutory standards established by Congress that govern CBD and CBD-derived products.”
The FDA has wide authority over products Americans consume, but severe lapses have shaken confidence in its ability to properly regulate them. @RepGuthrie and I want to know how and why the agency has fallen short and what it is doing to improve. https://t.co/bwzbO0QcdU
— Morgan Griffith (@RepMGriffith) September 19, 2022
They reminded Califf that when Congress passed the 2018 Farm Bill, it removed hemp and its derivatives containing no more than 0.3 percent THC per dry weight from the Controlled Substances Act (CSA) and, thus, Drug Enforcement Administration (DEA) control. But it preserved FDA’s authority to regulate cannabinoids under existing statute.
CBD is still “prohibited from being used as an ingredient in dietary supplements or an additive in any foods and beverages,” pending regulations issues by FDA. But a market for such products has quickly proliferated within the regulatory void, leaving it up to states to set a “patchwork” of rules and posing consumer safety concerns.
FDA’s go-to answer for the delay is that it is gathering scientific evidence to inform rulemaking, and the congressmen acknowledged that the agency held a meeting in 2019 to advance that conversation. However, it “has yet to create a regulatory roadmap for CBD and CBD-derived products to safely come to market” in the years since.
“Instead, the FDA has sent several warning letters to companies making unsubstantiated therapeutic claims and denying companies the opportunity to come to market in a way which is safe and effectively complies with established regulatory standards,” Griffith and Guthrie wrote. “Rather than denying new products from coming to market, the FDA must take action and establish a clear set of standards for companies to adhere by, especially since these products are already being sold in states across the nation.”
“There must be a uniform and established standard that responsible actors can follow that will allow for safe CBD and CBD-derived products to come to market—just as FDA sets standards for all other CFSAN-regulated products,” they said.
The lawmakers also pointed out the the House recently passed a bipartisan cannabis research bill that is meant to simplify the process for scientists to obtain and study cannabis, in part by providing a “more streamlined process and removing FDA barriers.”
“While the FDA inaction in the interim is unacceptable, it is our hope that this will expedite the generation of data and a lawful and safe interstate CBD marketplace,” they said.
Here are the questions the congressmen are asking FDA to answer by October 17:
1. In addition to the public activities noted in this letter, please describe what the agency has done since Congress legalized CBD in 2018 to gather more scientific data and research into CBD?
2. Please provide the specific scientific questions that FDA has posed to NIH, CDC, or to other federal agencies, or academic research institutions engaged in CBD research that it needs to answer in order to establish a regulatory framework, and on what timelines does the agency expect to receive study results?
3. Please provide any analysis conducted by the agency comparing the risks of a regulated CBD marketplace with the risks of a growing unregulated CBD marketplace.
4. Please provide documents related to the withdrawal of the “Cannabidiol Enforcement Policy” document which completed OMB review in July 2020 but was never released by this Administration. Who was ultimately responsible for that decision?
5. We understand that the FDA has issued warning letters but what other enforcement or oversight has the FDA taken against CBD product manufacturers?
a. Why has there been a low level of enforcement over the vast CBD products that are on the market today?
6. In July 2021, the FDA sent rejection letters to CBD companies objecting to their New Dietary Ingredient applications. One of the concerns the FDA cited in their letters was due to insufficient data on safety and efficacy surrounding CBD in a dietary supplement.
a. Please explain the rationale behind the lack of data when denying companies from attempting to safely come to market.
b. What can be done to increase the amount of data available for future decisions?
c. How many denials has the FDA issued for CBD products by companies that have attempted to submit a premarket “new dietary ingredient” notification?
Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner late last month. They expressed frustration over the “completely insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be permitted and regulated as a food additive.
After the CBD Product Safety and Standardization Act was filed in December 2021, the sponsors sought technical assistance from FDA to advise on key provisions. But four months after they sent the inquiry, FDA returned a “one-page” response that was “simply a reformatting of a document provided to Congress over two years ago,” the lawmakers said.
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At a House Appropriations subcommittee hearing in May, FDA’s Califf recognized that the agency had moved slowly with rulemaking for CBD in the food supply, stating that the situation “looks pretty much the same in terms of where we are now” as compared to when he first worked on the issue in 2016.
He said the FDA has taken steps to research the safety profile of cannabinoids to inform future rules, but he also punted the criticism about inaction to Congress, saying he doesn’t feel that “the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward.”
“We’re going to have to come up with something new,” Califf said. “I’m very committed to doing that.”
Stakeholders have strongly encouraged FDA to live up to its authority and provide guidelines and clarity for the industry. But as the lawmakers pointed out in both letters, the agency has limited its regulatory enforcement authority to sending warning letters to certain CBD businesses and denying cannabinoid marketing applications.
In May, for example, the agency simply sent warning letters to four cannabis companies for allegedly making unsanctioned claims about the medical benefits of CBD products they’ve marketed for animals.
FDA also recently warned consumers about marijuana-infused copycat food products that resemble popular brands and the risks of accidentally ingesting THC, particularly for children.
The agency separately issued its first set of warnings to companies over the allegedly illegal sale of products containing the increasingly popular cannabinoid delta-8 THC.
It sent five warning letters to companies that are marketing products with the intoxicating compound and making what the agency says are unsanctioned claims about their therapeutic potential.
In May, a top Republican on a key congressional committee also called on leadership to schedule a hearing to hold FDA accountable for its lack of action to set regulations for CBD and delta-8 THC products.
Read the letter to the FDA commissioner on CBD regulations below:
Photo by Kimzy Nanney.