A Republican congressman is demanding the Food and Drug Administration (FDA), turn over documents related to the agency’s decision to not regulate CBD products.
Rep. James Comer, R-KY, chair of the House Oversight and Accountability Committee sent a letter on Monday to FDA Commissioner Robert Califf, announcing a probe into the agency’s decisions and criticizing “insufficient justification for inaction” regarding CBD regulations.
In January, the FDA stated that after reviewing hemp and its derivatives, like CBD, for years, since they were legalized in the 2018 Farm Bill it had determined that no regulatory pathway was in place to implement rules that would allow the non-intoxicating cannabis to be sold as a food or dietary supplement. The FDA said that Congress must take action to create CBD regulations.
Comer, in his role as Oversight Committee Chairman, had promised to take FDA to task over the lack of regulations regarding cannabidiol.
The letter to Califf states that CBD is a popular product among adults, and usage has increased in recent years. It also says the World Health Organization has determined CBD to be safe and well tolerated.
He wrote: “As the FDA’s role in regulating CBD products becomes more important as science catches up, it is essential that they recognize their role.” The FDA’s failure to regulate non-intoxicating CBD has allowed dangerous products such as Delta-8, and hemp-derived intoxicants to reach the market. This lack of regulation is leading to increased concern about the safety of some products.
Comer stated that “proper regulation by the FDA will not only prevent bad actors from entering the marketplace but also increase the amount of contributions made by good faith manufacturers of a useful item for the American public.”
He said that the argument of the agency that there is no regulatory pathway for enacting CBD regulations is “insufficient justification for inaction,” which “directly affects the welfare” of the American people.
The FDA does not distinguish between the therapeutic CBD products and the products that are intoxicating. The FDA must act quickly, safely and efficiently in order to give the American public the proper information about CBD products.
The Chairman listed the “documents” and “information” he is asking FDA to give to the committee before May 1st:
1. All documents, communications and drafts related the announcement made on January 26, titled: “FDA Concludes Existing Regulatory Frameworks For Foods And Supplements Are Not Appropriate For Cannabidiol. Will Work With Congress On A New Way Forward.”
2. Documents and communications related to FDA’s assessment on the regulatory framework in place for CBD.
3. The FDA has all scientific data, research, reports and studies pertaining to the safety of CBD-based products.
Rep. Andy Harris, R-MD, has also criticized FDA for the lack of CBD regulation. He told the commissioner at a hearing in a congressional committee last month that ‘s inaction “disrupts public confidence”.
The top officials of the agency had previously indicated that it might require work from Congress in order to adequately regulate CBD.
In a hearing of the House Appropriations Subcommittee last year, Califf acknowledged that the agency was moving slowly on rulemaking for CBD within the food supply. He stated that the situation looked “pretty much the same” compared to his first work on the issue in 2016
He claimed that the FDA had taken steps to investigate the safety profile for cannabinoids in order to inform future regulations, but he also referred the criticism of the lack of action to Congress. He stated that he didn’t believe “that the current authorities we have, on the food or drug side, give us what we require to move forward.”
“We will have to find something new,” Califf stated. “I am very committed to that.”
The Congress has repeatedly attempted to fill the regulatory gaps for non-intoxicating cannabis.
Last month, for example, Reps. Morgan Griffith (R-VA), and Angie Craig (D-MN ) reintroduced two bills that were intended to create a regulatory pathway for hemp derivatives such as CBD in food and beverage supplements.
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Griffith and Rep. Brett Guthrie, (R-KY), sent a letter last year to Califf demanding answers about the lack of regulation for CBD.
In August, Griffith and bipartisan legislators wrote a letter to FDA commissioner. The lawmakers expressed their frustration at the “completely inadequate response” that the FDA provided to their bill requesting hemp-derived CBD be allowed and regulated as an additive in food.
The FDA announced that it would not be regulating CBD just days after released its finalized guidance which focuses on the development of cannabis-based medicines and details the process as well as unique considerations that scientists should take into account when it comes hemp and marijuana.
FDA recently praised its role in helping a state crackdown on a firm selling delta-8 THC gum, which they claimed are linked to serious adverse events.
Five companies selling CBD-containing foods and beverages received warning letters from the agency in November.
The agency did not specify why they targeted these five companies, out of many others that sell similar cannabidiol infused products. However, it stated that the products are “that people might confuse with traditional foods or drinks which could result in unintentional or excessive consumption of CBD.”
This is all happening in the context of FDA’s major task: Conducted a scientific review of marijuana at the request of President Joe Biden to help in assessing its federal scheduling. FDA’s recommendation will not be binding. However, officials expect that the Drug Enforcement Administration will make a recommendation for scheduling marijuana in accordance with its findings.
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