March 16, 2022
FDA intends to respond by the end of the month to a citizen petition filed by the Council for Responsible Nutrition (CRN) relating to the legality of NAC (N-acetyl-L-cysteine) in dietary supplements.
An FDA official, Douglas Stearn, advised CRN in a letter early this month that it expects to respond to its petition by March 31. Similarly, FDA intends to respond by March 31 to a NAC-related citizen petition filed by the Natural Products Association (NPA).
As Natural Products Insider reported Tuesday, the U.S. Department of Justice specified the date in a court filing disclosing its intent to move to dismiss a lawsuit filed by NPA against FDA related to NAC.
CRN in June 2021 requested FDA reverse the agency’s position that NAC-containing products cannot be dietary supplements. NPA made a similar request and also has sued FDA regarding its position that NAC cannot be marketed in supplements because it was first approved as a drug in 1963.
Among other arguments, CRN and NPA both have maintained NAC is not excluded from the definition of a dietary supplement because a drug preclusion—or “race-to-market”—clause in U.S. law doesn’t apply to “articles” studied or approved by FDA before passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
FDA in November advised CRN and NPA that it had not reached decisions on their petitions due to the “complex nature” of their requests and research the agency needed to complete. The agency also requested additional information from the petitioners and stakeholders, including information on the past use of NAC in products marketed as dietary supplements.
“We eagerly await a response to our well-reasoned arguments on the drug preclusion clause and hope the agency will substantively address these arguments, as industry, retailers and consumers deserve clear direction on the FDA's retroactive interpretation of drug preclusion,” Megan Olsen, senior vice president and general counsel of CRN, said in an email to Natural Products Insider. “A resolution to this issue is important, not only so that retailers and manufacturers can confidently make NAC available to those who benefit from it, but also will provide stakeholders clarity beyond NAC.”
FDA had nothing to add when reached for comment Wednesday about its forthcoming responses to the citizen petitions.
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