Two Republican congressmen are demanding answers from the Food and Drug Administration (FDA) on the continued lack of regulation for CBD as foods and dietary supplements.
Representatives Morgan Griffith (R-VA) and Brett Guthrie (R-KY) sent a letter to FDA Commissioner Robert Califf on Monday expressing concern about the extended timeline for CBD rulemaking since the hemp-derived cannabinoid was federally legalized under the 2018 Farm Bill and the resulting “significant market disruptions and regulatory uncertainty.”
Lawmakers said they understand the FDA continues to collect scientific data on the safety of CBD in the food supply — and that it intends to work with the independent nonprofit Reagan-Udall Foundation. the agency to assess regulatory processes as a whole — but they want the FDA to respond to Congress in the meantime.
“The United States currently has a robust but largely unregulated CBD market, leading to a dangerous market for consumers,” they wrote. “Consumer products containing CBD, such as dietary supplements, foods and beverages, are currently sold nationwide under a patchwork of state laws and regulations that were developed and enacted at the light of the FDA’s inaction.”
“It has even led to several cases of children buying over-the-counter CBD gummies with dangerous levels of delta-8 THC and suffering harm,” the letter states. “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 broad authority over the products Americans consume, but serious lapses have shaken confidence in its ability to properly regulate them. @RepGuthrie and I want to know how and why the agency failed 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% THC by dry weight from the Controlled Substances Act (CSA) and, by therefore, from the control of the Drug Enforcement Administration (DEA). But it preserved the FDA’s authority to regulate cannabinoids under existing law.
CBD is still “prohibited from being used as an ingredient in dietary supplements or as an additive in foods and beverages,” pending FDA regulations. But a market for such products quickly proliferated in the regulatory vacuum, leaving states to establish a “patchwork” of rules and posing safety issues for consumers.
The FDA’s response to the delay is that it’s gathering scientific evidence to inform rulemaking, and members of Congress have acknowledged that the agency held a meeting in 2019 to move that conversation forward. However, it “has yet to create a regulatory roadmap for CBD and CBD-derived products to come to market safely” in the years since.
“Instead, the FDA issued multiple warning letters to companies making unsubstantiated therapeutic claims and denying companies the ability to enter the market in a way that is safe and effectively meets established regulatory standards,” they said. writes Griffith and Guthrie. “Rather than preventing new products from coming to market, the FDA needs to take action and establish a clear set of standards that companies must meet, especially since these products are already being sold in states across the country. .”
“There must be a uniform, established standard that responsible actors can follow that will allow safe CBD and CBD-derived products to come to market, just as the FDA sets standards for all other CFSAN-regulated products. “, they said.
Lawmakers also pointed out that the House recently passed a bipartisan cannabis research bill that aims to simplify the process for scientists to obtain and study cannabis, in part by providing a “more streamlined process.” and removing FDA hurdles.”
“While the FDA’s inaction in the interim is unacceptable, we hope this will accelerate data generation and a legal and safe interstate market for CBD,” they said.
Here are the questions members of Congress are asking the 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 on CBD?
2. Please provide the specific scientific questions the FDA has posed to the NIH, CDC, or other federal agencies or academic research institutions engaged in CBD research that it needs to answer in order to establish a regulatory framework, and how soon does the agency expect to receive the results of the study?
3. Please provide any analysis conducted by the agency comparing the risks of a regulated CBD market with the risks of a growing unregulated CBD market.
4. Please provide documentation related to the withdrawal of the “Cannabidiol Enforcement Policy” document which was reviewed by the OMB in July 2020 but was never released by this administration. Who was ultimately responsible for this decision?
5. We understand that the FDA has issued warning letters, but what other enforcement or oversight actions has the FDA taken against manufacturers of CBD products?
a. Why has there been a low level of enforcement on the vast CBD products that are on the market today?
6. In July 2021, the FDA sent rejection letters to CBD companies opposing their applications for new food ingredients. One of the concerns cited by the FDA in its letters was due to insufficient safety and efficacy data surrounding CBD in a dietary supplement.
a. Please explain the reason for the lack of data when refusing companies to attempt to get to market safely.
b. What can be done to increase the amount of data available for future decisions?
vs. How many denials has the FDA issued for CBD products from companies that attempted to submit a pre-market “new food ingredient” notification?
Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner late last month. They expressed frustration with the “totally insufficient response” the agency provided in response to their bill calling for hemp-derived CBD to be licensed and regulated as a food additive.
After the CBD Product Safety and Standardization Act was filed in December 2021, sponsors requested technical assistance from the FDA to advise them on key provisions. But four months after sending the request, the FDA returned a “one-page” response that was “merely a reformatting of a document provided to Congress over two years ago,” the lawmakers said.
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During a House Appropriations subcommittee hearing in May, the FDA’s Califf acknowledged that the agency had made slow progress with developing rules for CBD in the food supply, saying the situation “seems about the same in terms of where we are now” 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 pitched criticism of the inaction to Congress, saying he doesn’t think ” the current authorities that we have on the side of food or medicine necessarily give us what we need to move forward on the right path.
“We’re going to have to come up with something new,” Califf said. “I’m very determined to do that.”
Stakeholders strongly encouraged the FDA to live up to its authority and provide guidance and clarification to industry. But as lawmakers pointed out in the two letters, the agency has limited its enforcement power to sending warning letters to certain CBD companies and denying applications to market cannabinoids.
In May, for example, the agency simply sent warning letters to four cannabis companies for allegedly making unauthorized claims about the medical benefits of CBD products they marketed for animals.
The FDA also recently warned consumers against copycat marijuana food products that resemble popular brands and the risks of accidentally ingesting THC, especially to children.
The agency has separately released its first set of warnings to businesses about the allegedly illegal sale of products containing the increasingly popular delta-8 cannabinoid THC.
It sent five warning letters to companies that market products containing the intoxicating compound and make what the agency says are unauthorized claims about their therapeutic potential.
In May, a senior Republican on a key congressional committee also called on leaders to schedule a hearing to hold the FDA accountable for its inaction to establish regulations for CBD and delta-8 THC products.
Read the letter to the FDA commissioner on CBD regulations below:
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Photo by Kimzy Nanney.