A first-of-its-kind congressional committee hearing took place on Thursday, with lawmakers examining 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.
“FDA announced earlier this year that it’s needs a new regulatory framework for hemp and CBD,” Chairwoman Lisa McClain (R-MI) said in her opening remarks. “Translation: Give us more authority. Give us more money. Give us more staff and only then will we actually do our duties under the law.”
“This announcement has led to confusion and uncertainty in the market, which has suppressed the ability for good faith manufacturers to sell CBD products,” she said. “It only benefits bad actors who capitalize on the confusion and the flood of the market with potentially unsafe products. The FDA must do better and use their already existing authority to regulate how derived products you know actually do the job they were signed up to do.”
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.
“Even though we have more and more data available to regulators to make appropriate decisions about CBD in the marketplace, the FDA has taken no meaningful action to provide clear guidance and certainty in the market, refusing to regulate CBD products under existing lawful pathways,” Comer said at Thursday’s hearing. “Without FDA regulations, the good faith producers of these products are left with no path forward and consumers are left in the dark.”
“It’s well past time for FDA to do its job and be more than just a major obstacle to the economic prosperity of our great farmers and producers of these products,” he said. “The American people need to know what is in their products, and the FDA has the power to enforce reasonable regulations by regulating CBD as a dietary supplement or food additive.”
Rep. Jamin Raskin (D-MD), ranking member on the full House Oversight Committee, said that he agrees that “we need reasonable regulation of the hemp and hemp derivative marketplace to protect consumers and to ensure the good actors in the hemp industry can grow their businesses and we could have a legitimate and flourishing market in hemp.”
“But we need to make sure that the regulations make sense,” Raskin, who also touted a separate bill that he introduced on Thursday to prevent the denial of security clearances or federal employment based on past or current marijuana use, said. However, the congressman said “FDA realistically cannot regulate the entire world of hemp and its derivatives without additional research authority and resources.”
Rep. Katie Porter (D-CA), the subcommittee’s ranking member, also made that argument, siding with FDA despite the hemp industry’s repeated complaints about the agency’s inaction and criticism that it already has the means to develop CBD regulations.
“Republicans have convened this hearing because they believe, apparently, that the FDA doesn’t need any more authority from Congress to properly regulate hemp derived products,” she said. “The problem is that some of the same lawmakers who want to do oversight of the FDA for being cautious about its existing powers would turn around and blast the agency if they ever felt like it went too far beyond its legal authority. Look, we can’t have it both ways here.”
“The FDA knows Congress will appropriately hold it accountable if the agency exceeds its authority. That’s our job,” she argued. “So the FDA is not going to take the risk of going too far. Why ask them to take that risk when we could just work together across the aisle on some common sense legislation.”
Comer, the full Oversight Committee chairman, 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, was among those who testified at Thursday’s meeting.
“Unfortunately, the U.S. hemp industry has been struggling considerably in the last few years,” he said. “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 also testified 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. “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.”
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.
“This inaction has needlessly put consumers at risk by allowing an unregulated marketplace to be flooded with low-quality, potentially unsafe products,” Jim Higdon, co-founder of the Kentucky-based CBD company Cornbread Hemp, told Marijuana Moment. “Meanwhile, legitimate CBD companies have been begging for these regulations in order to create a safe and prosperous CBD marketplace.”
“Anyone interested in the legalization of cannabis should pay close attention to this hearing because the challenges faced by the CBD industry to get appropriately regulated by the executive branch is the same problem that full-strength cannabis will face on the other side of federal legalization,” he said. “Getting legalized by Congress is only half the battle.”
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. (Full Story)