WASHINGTON — The Council for Responsible Nutrition (CRN) Wednesday expressed disappointment with the Food and Drug Administration’s response to its citizen petition about the status of N-acetyl-L-cysteine (NAC) as a legal dietary supplement.
“CRN is extremely dissatisfied with today’s ‘tentative response’ from FDA to CRN’s June 1 citizen petition,” CRN president and CEO Steve Mister said in a statement.
“FDA’s initial position, expressed in a series of warning letters in July 2020, appears to be that products containing N-acetyl-L-cysteine (NAC) may not be lawfully marketed as dietary supplements,” said Mister. “The legal issues here are clear: The provisions of the Dietary Supplement Health and Education Act of 1994 (DSHEA) may not be interpreted retroactively to remove ingredients that were lawfully marketed in 1994 and have enjoyed a long history of safe use since then. The delay in clearing up the status of NAC by asking for more data and refusing to admit its error disregards the law and disserves consumers who use NAC.
“This is not a complicated determination for FDA to make. DSHEA makes clear that ingredients in use as dietary supplement ingredients prior to its enactment are grandfathered into the supplement marketplace. Thus, pharmaceutical manufacturers could not have had any expectation of exclusivity in the years prior to the creation of this provision of the law. Given the long history of safe use of NAC, FDA cannot now try to establish a safety concern in order to award this ingredient exclusively to drug makers. Even members of Congress have expressed concerns over FDA’s position on NAC while the agency continues to avoid admitting its error in the warning letters.
“As FDA unduly prolongs making clear NAC’s status, many retailers have discontinued selling supplements containing NAC in misplaced reliance on those warning letters, which means consumers have a difficult time locating these products. FDA’s delay is a disservice to the dietary supplement industry, retailers, health care practitioners, and most importantly, the more than 200 million supplement users who rely on FDA to do its job.”