A congressional committee has scheduled a hearing for next week focused on the Food and Drug Administration’s (FDA) refusal to enact regulations to allow for the marketing of hemp-derived CBD products. And bipartisan and bicameral lawmakers have separately reintroduced a bill to fill the regulatory gap.
The House Oversight and Accountability Subcommittee on Health Care and Financial Services scheduled the hearing—titled “Hemp in the Modern World: The Years long Wait for FDA Action”—for July 27.
Chairwoman Lisa McClain (R-MI) said in a press release on Thursday that “FDA has failed for too long to do its job to ensure the safety of legalized hemp-derived products.”
“Without these regulations, dangerous products could make their way to the shelves while safe and credible CBD products could be prevented from entering the market,” she said. “We are going to investigate why exactly the FDA has decided to ignore their regulation responsibilities related to CBD and other areas of jurisdiction. We need to ensure that the FDA is not setting what would be a dangerous precedent and using this as an opportunity to seek more authority and resources from Congress.”
Rep. James Comer (R-KY), who chairs the full committee, has sharply criticized FDA after the agency announced in January that it would not be developing CBD regulations, stating that there is not an available pathway to create such rules and it would require congressional action.
To that end, Sens. Ron Wyden (D-OR), Rand Paul (R-KY) and Jeff Merkley (D-OR), along with Rep. Earl Blumenauer (D-OR), separately filed legislation on Thursday that would remove regulatory barriers that FDA claims prevents it from allowing CBD sales in the food supply or as dietary supplements.
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.
“Despite being legally grown in the United States for nearly five years, hemp and hemp-derived CBD are still in a regulatory gray zone that puts consumers at risk and holds producers back,” Wyden said in a press release. “The FDA says it needs Congress to act. We’ve got the bill to ensure equal and safe access to hemp-derived CBD.”
Merkley added that “our hemp farmers need updated CBD regulations to thrive.”
“FDA get it done!” he said.
Paul, for his part, said that CBD products and businesses “have earned their recognition in the marketplace, but the FDA, unfortunately, hasn’t treated them like any other food additive or dietary supplement.”
“The Hemp Access and Consumer Safety Act directs the FDA to regulate hemp products properly and provides a huge relief to hemp farmers, processors, and merchants,” the senator said.
Comer, meanwhile, 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.
Now lawmakers are gearing up to formally address FDA’s inaction at the subcommittee hearing.
Jonathan Miller, general counsel to the U.S. Hemp Roundtable, will be among those testifying at the meeting, the organization announced in a press release on Thursday.
“I am honored to serve as a witness for this historic hearing to testify to the extraordinary challenges faced by hemp farmers and CBD consumers over the past five years,” Miller said. “I look forward to shedding light on the urgent need for clear regulations that ensure consumer safety and promote the growth of the hemp industry.”
Two other witnesses are listed to testify at the hearing next week: 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.
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.
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)