Jarrow Formulas has released N-A-C Sustain, with 500mg of N-Acetyl-L-Cysteine in a vegetarian capsule form. The supplement is an antioxidant amino acid, and supplies L-Cysteine, which acts as an antioxidant itself or as precursor to glutathione, the company says. It is meant to support glutathione production in the brain, liver,...
This article has been updated with comments from the industry. Washington, D.C.—The Food and Drug Administration (FDA) has issued Guidance for Industry: Policy Regarding N-acetyl-L-cysteine. The guidance advises dietary supplement manufacturers, distributors, and other stakeholders of FDA's intent to exercise enforcement discretion with respect to the sale and distribution of certain...
Washington, D.C.—Earlier this year, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a discussion draft of legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes the Durbin-Braun premarket approval concept. As WholeFoods Magazine reported, the Natural Products Association (NPA) has been cautioning...
Washington, D.C.—The U.S. Food and Drug Administration (FDA) announced in a Constituent Update that it is issuing “Policy Regarding N-acetyl-L-cysteine: Draft Guidance for Industry” to be published on April 22, 2022. FDA said the draft guidance, when finalized, will explain the agency's intent to exercise enforcement discretion with respect to...
In this episode of The Natural View, WholeFoods Magazine VP of Media Heather Wainer talks with Kyle Turk, Director of Government Affairs at the Natural Products Association (NPA), about legislation that would place age restrictions on nutritional supplements. NPA is spearheading grassroots campaigns across the country against these bills—in Rhode...
Washington, D.C.—In July 2020, the U.S. Food and Drug Administration (FDA) sent warning letters to seven supplement companies selling products containing N-acetyl-L-cysteine (NAC), claiming that NAC was not lawful for sale as an ingredient in a dietary supplement because NAC had already been approved as a drug prior (in 1963)...
Washington, D.C.—The Natural Products Association (NPA) has filed a Citizen’s Petition with the Food and Drug Administration, requesting that N-acetyl-L-cysteine (NAC) not be excluded from the definition of a dietary supplement. As WholeFoods previously reported, despite decades on the marker as a dietary supplement, in July 2020, FDA issued multiple...
