INDUSTRY UPDATES
May 23, 2022
U.S. Hemp Roundtable Requests FDA Issue Policy Of Enforcement Discretion For CBD
Today, the U.S. Hemp Roundtable sent a letter to FDA Commissioner Robert Califf requesting the immediate issue of an enforcement discretion policy for dietary supplements containing hemp-derived CBD and other cannabinoids.
The FDA has recently announced its intent to exercise enforcement discretion with respect to the sale and distribution of certain products that contain N-acetyl-L-cysteine (NAC) that are labeled as dietary supplements, along with the agency’s consideration of a rulemaking to allow the use of NAC in dietary supplements. The U.S. Hemp Roundtable is now asking FDA to take these same actions for dietary supplements that contain legal hemp-derived cannabidiol (CBD) and other lawful hemp ingredients, especially in light of new safety data on CBD.
“We recognize that safety was a factor in FDA’s decision to issue the draft guidance on NAC and agree that safety should always guide FDA policy,” reads the letter. “Indeed, there has been no indication that CBD poses significant safety concerns at the levels typically found in CBD dietary supplements, based on adverse event reporting, observational data, and toxicology data on CBD.”
Last Tuesday, Commissioner Califf acknowledged that his agency has taken little regulatory action on CBD products in recent years despite the federal legalization of hemp and its derivatives. “It looks pretty much the same in terms of where we are now,” he told a House Appropriations subcommittee during a hearing that touched briefly on CBD regulation. “We just know more because we’ve done more research.”
Jonathan Miller, U.S. Hemp Roundtable General Counsel, told Marijuana Moment in a statement that he appreciated Califf’s responses at Thursday’s hearing. “I’m quite encouraged by the tone of Commissioner Califf’s remarks—his frustration that nothing has been accomplished by the agency in the six years since he last served in that position, as well as his repeated commitment to identify pathways for CBD,” Miller said. “He’s looking for a creative approach, and the U.S. Hemp Roundtable looks forward to working with FDA on this.”
While Califf insisted he wants FDA to continue moving forward on regulations for CBD products, he said the agency likely needs broader regulatory powers from Congress to get it done. “I don’t think the current authorities we have on the food side or the drug side necessarily give us what we need to have to get the right pathways forward,” he said. “We’re going to have to come up with something new. I’m very committed to doing that.”
The U.S. Hemp Roundtable strongly agrees and continues to urge Congress to pass HR 841, HR 6134 and S 1698 that would ensure that hemp-derived extracts like CBD are regulated as dietary supplements and food and beverage ingredients.
“We are open to other creative solutions like you suggest and have been willing for the past three years to sit down with FDA to discuss alternative approaches. Unfortunately, the agency has been unwilling to meet with us to discuss legislative options,” Miller states in the letter. “At the same time, we have been told FDA is urging congressional staff not to proceed with existing legislation. We ask for your help to break this stalemate, and we stand by to participate in productive negotiations with your staff to come up with solutions that best protect American consumers.”
Read more from Marijuana Moment.
Take action today by contacting your members of Congress and asking them to support legislation that would regulate CBD now.
