A Republican congressional committee chairman is demanding that the Food and Drug Administration (FDA) turn over documents relating to the agency’s decision not to regulate CBD products.
Rep. James Comer (R-KY), chair of the House Oversight and Accountability Committee, sent a letter to FDA Commissioner Robert Califf on Monday, announcing an investigation into the agency’s decision and criticizing the “insufficient rationale for inaction” on CBD regulations.
FDA said in January that, after years of review since hemp and its derivatives like CBD were legalized under the 2018 Farm Bill, it determined that there is not a regulatory pathway in place to enact rules allowing the non-intoxicating cannabinoid to be marketed as a food item or dietary supplement. It said that congressional action is required to develop CBD regulations.
Prior to that announcement, Comer had pledged to confront FDA over the lack of regulations for cannabidiol in his capacity as Oversight Committee chairman.
“CBD is an increasingly popular product among adults and has seen an uptick in usage in recent years,” the letter to Califf says, adding that the World Health Organization (WHO) has found CBD to be generally safe and well-tolerated.
“As science is catching up regarding the safety of CBD usage, it is imperative that the FDA recognize its role in regulating these products,” he wrote. “The lack of regulation of non-intoxicating CBD products have allowed for potentially dangerous products to enter the market in the form of Delta-8 and other hemp-derived intoxicants, leading to increasing concern that some products contain potentially dangerous ingredients due to the lack of regulation.”
“Proper regulation from the FDA would not only prevent bad faith actors from entering the market but will increase the amount of good faith manufacturers’ contributions of a useful product for the American public,” Comer said.
He added that the agency’s argument that there’s not a regulatory pathway to enact CBD regulations is an “insufficient rationale for inaction” that is “directly affecting the welfare of the American public.”
“Without allowing for therapeutic CBD products to be regulated as dietary supplements such as melatonin or fish oils, the good faith actors in the industry are unable to enter the market and provide people with helpful products because they are currently not distinguished under the FDA from the intoxicating products containing Delta-8. It is imperative that the FDA engages in this regulation quickly, safely, and efficiently to provide proper guidance to the American people about the safety of CBD products.”
The chairman listed “documents and information” that he’s asking FDA to provide to the committee by May 1:
1. All documents, communications, and drafts related to the January 26 announcement titled “FDA Concludes that Existing Regulatory Frameworks for Foods and Supplements are Not Appropriate for Cannabidiol, Will Work with Congress on a New Way Forward.”
2. All documents and communications relating to the FDA’s assessment of the existing regulatory framework at issue regarding CBD.
3. All scientific data, reports, and research in the possession of the FDA relating to the safety of CBD products for consumption.
Another GOP congressman, Rep. Andy Harris (R-MD), has similarly blasted FDA over the lack of CBD regulations, telling the commissioner in a committee hearing last month that the inaction is “disrupting public confidence” in its abilities.
Top officials in the agency have previously signaled that they felt it may take work from Congress to adequately regulate CBD.
At a House Appropriations subcommittee hearing last year, 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.”
There have been repeated efforts by congressional lawmakers to fill the regulatory gap for the non-intoxicating cannabinoid.
For example, Reps. Morgan Griffith (R-VA) and Angie Craig (D-MN) reintroduced a pair of bills last month meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
Griffith and Rep. Brett Guthrie (R-KY) sent a letter to Califf last year, demanding answers over the continued lack of regulations for CBD for those purposes.
Griffith and other bipartisan lawmakers sent a separate, related letter to the FDA commissioner in August. 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.
FDA’s announcement that it wouldn’t be regulating CBD came days after the agency released finalized guidance that focuses on developing cannabis-based drugs and outlined the process and unique considerations for scientists when it comes to hemp and marijuana.
FDA also recently touted its role helping a state agency crack down on a company selling delta-8 THC gummies that they said are linked to “serious adverse events.”
In November, the agency sent warning letters to five companies that sell foods and beverages containing CBD.
The agency didn’t specify why it targeted those particular five companies out of the many more that market similar cannabidiol-infused consumables, but it said that they sell products “that people may confuse for traditional foods or beverages which may result in unintentional consumption or overconsumption of CBD.”
All of this comes in the background of a major task for FDA: Conducting a scientific review into marijuana, at the direction of President Joe Biden, to aid in an assessment of its federal scheduling. FDA’s recommendation won’t be binding, but officials say they expect the Drug Enforcement Administration (DEA) to produce a scheduling recommendation that’s consistent with their findings about its risks and benefits. (Full Story)