citizen’s petition
CRN Submits Citizen Petition Requesting FDA to Re-interpret Drug Preclusion Clause
The Council for Responsible Nutrition (CRN) has submitted a Citizen Petition to the FDA requesting that the agency to reconsider its interpretation of the Drug Preclusion Clause. According to the Washington, DC-based trade association, the Clause has been, and will likely continue to be, misapplied to dietary supplement ingredients that FDA has previously acknowledged as […]
NPA and ANH File Citizen’s Petition With FDA on Specific NMN Relief
The Natural Products Association (NPA) along with the Alliance for Natural Health (ANH) in a Citizen’s Petition to the Food and Drug Administration (FDA) requested the FDA: Determine nicotinamide mononucleotide (NMN) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B); Commit to exercising enforcement discretion in connection with the marketing […]
CRN and NPA Respond to FDA’s Enforcement Discretion Guidance on NAC
Both the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have responded to the U.S. Food and Drug Administration’s (FDA) draft enforcement discretion guidance on the use of NAC (n-acetyl-cysteine). Steve Mister, president and CEO of CRN, stated that “CRN appreciates FDA’s quick action following its March 31 response to our citizen petition with […]
CRN Dismisses FDA Response on N-acetyl-cysteine (NAC)
The Council for Responsible Nutrition (CRN) on March 31 denounced FDA’s decision regarding the legal status of n-acetyl-cysteine (NAC) as a dietary ingredient. “CRN is extremely disappointed and unconvinced by FDA’s response today that it has chosen to deny CRN’s citizen’s petition while holding out the possibility that it may open a rulemaking specific to NAC instead,” […]
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