NAC
NAC and Glycine: The Efficient Way to Raise Glutathione
The antioxidant glutathione (GSH) is a tripeptide1,2 primarily synthesized in the liver and composed of the amino acids cysteine, glutamic acid and glycine.3,4 It may be argued that GSH is the most important tripeptide in the body, playing critical roles in the synthesis and repair of DNA and protein, as well as the synthesis of ...
NPA Files Lawsuit Against FDA’s “Unlawful Application” of Food, Drug and Cosmetic Act
The Natural Products Association (NPA) filed a lawsuit on August 28 against the U.S. Food and Drug Administration (FDA), requesting the agency cease its “unlawful retroactive application” of the Food, Drug and Cosmetic Act against nicotinamide mononucleotide (NMN). “We are extremely grateful for the leadership shown by our organization’s members in deciding to take this ...
NPA Files Citizen Petition Regarding Labeling of Fungus-Derived Products
In a Citizen Petition submitted to the U.S. Food and Drug Administration (FDA) on August 9, the Natural Products Association (NPA) requested that FDA: Amend 21 C.F.R. § 101 to incorporate labeling aspects based on the American Herbal Products Association’s (AHPA) labeling guidance for mushrooms; and/or Commit to exercising enforcement discretion until the Agency provides ...
NPA Issues Statement in Response to FDA’s Refusal to Hold Public Hearing Regarding NMN
On July 20, the U.S. Food and Drug Administration (FDA) rejected a request by Rep. Jeff Duncan (R-SC), a member of the House Energy and Commerce Committee, to hold a public hearing on the agency’s position on nicotinamide mononucleotide (NMN). FDA stated that a public comment period would be sufficient. In response, the Natural Products ...
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 ...
CRN: FDA Must Prioritize Supplements, Facilitate Stronger Collaboration and Improved Communication
Any reorganization structure for human foods proposed by U.S. Food and Drug Administration (FDA) must include dietary supplements and the new deputy commissioner must be accountable for supplement regulation, the Council for Responsible Nutrition (CRN) President & CEO Steve Mister and SVP Scientific & Regulatory Affairs Andrea Wong, PhD, stated in a letter to FDA ...
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 Responds to FDA Letter Announcing β-NMN Is Not A Dietary Supplement
On Nov. 11, the Council for Responsible Nutrition (CRN) responded to the U.S. Food and Drug Administration’s (FDA’s) announcement that beta-nicotinamide mononucleotide (β-NMN) is not a legal dietary ingredient. CRN President and CEO Steve Mister issued comments expressing his dismay about the ruling. “CRN is alarmed that, once again, FDA changed its position on whether an ...
Following Final NAC Guidance and Marketplace Stabilization, NPA Withdraws FDA Lawsuit
After securing final guidance for N-Acetyl-Cysteine (NAC) through a citizen petition and lawsuit, the Natural Products Association (NPA) dismissed its case against the U.S. Food and Drug Administration (FDA), which preserves legal rights and standing should additional action be necessary. The guidance also initiates the process for export certificates for NAC, which was a primary ...
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 ...
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