A first-of-its-kind congressional committee hearing is taking place on Thursday to examine the impacts of Food and Drug Administration (FDA) inaction on developing regulations to allow for the sale of hemp-derived CBD as food items or dietary supplements.
The House Oversight and Accountability Subcommittee on Health Care and Financial Services announced the scheduling of the hearing—titled “Hemp in the Modern World: The Years long Wait for FDA Action”—last week.
Watch the committee hearing on FDA and CBD live in the video below:
Rep. James Comer (R-KY), who chairs the full Oversight Committee, has sharply criticized FDA after the agency announced in January that it would not be developing CBD regulations because it said that there is not an available pathway to create such rules and it would require congressional action.
The congressman said in April that his panel would be launching an investigation into the matter, and he requested that FDA turn over documents related to its decision not to regulated the cannabinoid. Even before the agency made that decision, the congressman expressed his intent to address the lack of rules.
Jonathan Miller, general counsel to the U.S. Hemp Roundtable, will be among those testifying at the meeting.
“Unfortunately, the U.S. hemp industry has been struggling considerably in the last few years,” he said in written testimony published ahead of the meeting. “And this turmoil is due in large part to decisions made by the FDA.”
“The hemp industry may be unique in that we are coming to Congress to ask: Please, regulate us. A rational, sensible regulatory framework for the hemp industry can also provide a needed financial jolt to a nation emerging through economic recovery,” Miller said. “Regulatory relief for the hemp-derived CBD industry constitutes an economic stimulus package for the nation’s farmers and small businesses without requiring one dime from the American taxpayer.”
Three other witnesses are also set to testify at the hearing: Gillian Schauer, executive director of the Cannabis Regulators Association (CANNRA); Rayetta Henderson, senior managing scientist at ToxStrategies, LLC and Richard Badaracco, a former Drug Enforcement Administration (DEA) special agent who now serves as the president-elect of the Kentucky Narcotic Officers Association and as a board member of the U.S. Hemp Authority.
“Whether through the Farm Bill or another priority piece of legislation, a broad regulatory framework is urgently needed to address hemp-derived cannabinoid products,” Schauer said in written testimony. “Congress has an opportunity to learn from the approaches that states have taken to set a thoughtful and comprehensive federal regulatory framework. The regulation of hemp-derived products is complex and nuanced, and state regulators understand those nuances better than anyone.”
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Badaracco, the former DEA special agent, said that without FDA regulations, “the U.S. Hemp Authority encourages manufacturers who participate in the program to use best practices and high standards in preparing their products.”
“The standards based largely on the FDA’s regulatory regime concerning dietary supplements and food and beverage additives, is enforced by third-party auditors,” he said. “However, self-regulation is not sufficient; federal regulation is necessary to ensure that all products on the marketplace maintain the highest safety standards.”
Henderson, meanwhile, provided extensive data on the safety and efficacy profile of cannabidiol, saying that “science-based evaluations and an aligned consensus on the safety of CBD are in the best interest of public health and the consumer.”
The hemp industry took a major plunge in 2022, according to a report from the U.S. Department of Agriculture (USDA) that was released in April—and stakeholders say the FDA’s refusal to issue regulations for CBD products is largely to blame.
Bipartisan congressional lawmakers refiled a separate pair of bills in March that are also meant to provide a pathway for the regulation of hemp derivatives like CBD as dietary supplements and food and beverage additives.
Sens. Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR), along with Rep. Earl Blumenauer (D-OR), separately filed legislation last week that would remove regulatory barriers that FDA claims prevents it from allowing CBD sales.
The Hemp Access and Consumer Safety Act, which was also introduced last Congress but did not advance, would exempt “hemp, hemp-derived cannabidiol, or a substance containing any other ingredient derived from hemp” from certain federal restrictions, while permitting officials to enact labeling and packaging rules.
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.
Meanwhile, the agency has received some bipartisan praise for releasing first-ever guidance on developing psychedelic medicines. At the same time, it is actively working to review the federal scheduling of marijuana under a directive from President Joe Biden last year.
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