U.S. Hemp Roundtable Requests FDA Issue Policy Of Enforcement Discretion For CBD

U.S. Hemp Roundtable Requests FDA Issue Policy Of Enforcement Discretion For CBD
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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. Read the letter here. 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 “We recognize that safety was a factor in FDA’s decision to issue the draft guidance on NAC and agree that safety should always guide FDA policy,” reads the letter.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…

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Source : U.S. Hemp Roundtable Requests FDA Issue Policy Of Enforcement Discretion For CBD

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