Citizen’s Petition
FDA’s Long-sought Guidance on NAC Follows NPA’s Lawsuit and Citizen’s Petition
Following a Citizen’s petition and lawsuit filed by the Natural Products Association (NPA) against the U.S. Food and Drug Administration (FDA) for a dietary supplement issued enforcement discretion for N-Acetyl-Cysteine (NAC) has resulted in the agency issuing final guidance. “This is a big win but it is bittersweet for sure. Although it was NPA’s leadership ...
NPA Files Citizen’s Petition With FDA on Specific CBD Relief
On Feb. 22, in a Citizen’s Petition to the U.S. Food and Drug Administration (FDA), the Natural Products Association (NPA) requested the FDA either: Determine cannabidiol (CBD) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B) allowing the Commissioner the ability to exercise enforcement discretion in a specific and selective ...
NPA Files Citizen Petition with FDA
In a Citizen’s Petition to the U.S. Food and Drug Administration (NPA), the Natural Products Association (NPA) requested that N-acetyl-L-cysteine (“NAC”) not be excluded from the definition of a dietary supplement. “The Food and Drug Administration has not established a public health risk for NAC,” said Daniel Fabricant, PhD, president and CEO of NPA. “Not ...
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