FDA continues to face pressure from U.S. lawmakers over its inaction in creating a regulatory framework for hemp-derived CBD.
In a recent letter, two Republican congressmen, Morgan Griffith of Virginia, and Brett Guthrie of Kentucky, requested FDA answer several questions pertaining to CBD.
They asked, for example, what scientific questions FDA has posed to federal agencies or academic institutions engaged in CBD research that it must answer to create a regulatory framework.
“The FDA’s regulatory approach to CBD has created unnecessary uncertainty in the marketplace around these products,” Griffith and Guthrie wrote to FDA Commissioner Robert Califf, M.D., in a Sept. 19 letter. “The United States currently has a robust but largely unregulated CBD market, which leads to an unsafe marketplace for consumers.”
The seven-page letter also criticized FDA’s handling of tobacco products, asserting FDA has failed to meet “the challenge of making harm reduction in tobacco regulation a reality.”
“The FDA has wide authority over products Americans consume, but severe lapses have shaken confidence in its ability to properly regulate them,” Griffith said in a recent statement. “In areas from baby formula to CBD products to tobacco, the FDA has been sluggish in solving problems, it has been unresponsive to Congress, and it has been deficient in the execution of responsibilities given to it by law. Congressman Guthrie and I want to know how and why the agency has fallen short and what it is doing to improve.”
In a separate letter sent in August to Califf and released by the U.S. Hemp Roundtable, Griffith and three of his colleagues in the House of Representatives criticized FDA for technical assistance it provided in response to their legislation, H.R. 6134, the CBD Product Safety and Standardization Act.
“This one-page TA, which took your agency nearly four months to provide in response to our request, is simply a reformatting of a document provided to Congress over two years ago, does not address provisions of our bill drafted specifically to address product safety, and is a completely insufficient response at this moment when cannabidiol (CBD) products are proliferating around the country,” wrote Griffith and Reps. Angie Craig, Kathleen Rice and Dan Crenshaw.
H.R. 6134 is focused on the regulation of CBD as a food rather than as a dietary supplement. A separate bill focused on CBD in dietary supplements, H.R. 841—otherwise known as the Hemp and Hemp-Derived CBD Consumer Protection and Market Stabilization Act of 2021—has garnered over 40 co-sponsors, including most recently Rep. Dina Titus (D-Nevada). The chairman of the House Agriculture Committee, Rep. David Scott (D-Georgia), co-sponsored the bill in August.
“Rather than denying new products from coming to market, the FDA must take action and establish a clear set of standards for companies to adhere by, especially since these products are already being sold in states across the nation,” Griffith and Guthrie wrote to Califf in the Sept. 19 letter.
In May, Califf said his agency was committed to moving forward on a pathway for CBD. However, he suggested the agency doesn’t have the current authorities to do so today and will require collaboration with lawmakers on Capitol Hill.
“I don’t think the current authorities we have on the food side, the drug side, necessarily give us what we need to have to get the right pathways forward,” Califf said in response to a question during a May 19 hearing held by a subcommittee of the House Committee on Appropriations. “We’re going to have to come up with something new. I’m very committed to do that.”
Hemp supporters are continuing to look to Congress to support the industry. The U.S. Hemp Roundtable recently announced an annual “Member DC Fly-In” where members met with more than 40 lawmakers and congressional offices.
Among the highlights, according to the Sept. 23 update, was a dinner with Senate Republican Leader Mitch McConnell and former Transportation Secretary Elaine Chao. The event “served as a brainstorming session to determine next steps in legislative initiatives to regulate CBD and promote agricultural sustainability through hemp fiber and grain,” U.S. Hemp Roundtable said.
FDA emailed a brief statement to Natural Products Insider in response to a request for comment regarding its plans for a regulatory framework for hemp-derived CBD.
“The FDA recognizes that there is significant interest in the development of therapies and other consumer products derived from cannabis and its components, including CBD,” the agency said. “We are committed to working efficiently to further clarify our regulatory approach to these products, using science as our guide and upholding our rigorous public health standards.”
Norman Birenbaum, a veteran cannabis regulator in New York and Rhode Island, recently joined FDA as a senior public health advisor. Birenbaum also was the founding president of the Cannabis Regulators Association (CANNRA), according to an FDA official who announced the new hire. CANNRA’s members include the top cannabis regulatory agencies and other state agencies involved in implementation of cannabis policy in more than 40 states and U.S. territories.
“With his expertise in policy analysis and legislative outreach related to cannabis and cannabis-derived products, Norman is excited about creating the high-value partnerships needed for FDA’s outreach throughout the health care community, including with patients and patient advocacy groups,” Douglas Throckmorton, M.D., deputy center director for regulatory programs with FDA’s Center for Drug Evaluation and Research (CDER), shared in an email to FDA staff.
Some industry stakeholders are hopeful that Birenbaum’s hiring signals a path forward for hemp-based CBD.
“After four years of inaction, we are hopeful that the appointment of Norman Birenbaum by the FDA signals a positive step forward for the regulation of hemp-derived cannabinoids such as CBD,” Jonathan Miller, general counsel to the U.S. Hemp Roundtable, said in a statement on the organization’s website. “We appreciated working with Birenbaum on the development on New York’s landmark regulatory regime for hemp, and we look forward to working closely with him on the development of a regulatory framework for CBD products to ensure consumer safety and product quality across the country.”
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