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)...
Salt Lake City, UT—The United Natural Products Alliance has submitted comments to the FDA Office of Dietary Supplement Programs (ODSP) regarding NAC, according to a press release. The comments were submitted in response to a Constituent Update titled FDA Requests Information Relevant to the Use of NAC as a Dietary...
Silver Spring, MD—Industry associations have submitted comments to FDA regarding the agency’s tentative responses to the citizen petitions from Council for Responsible Nutrition (CRN) and Natural Products Association (NPA) regarding the legal status of NAC. The American Health Products Association (AHPA) submitted comments, focusing on identifying NAC-containing products sold pre-DSHEA.
Washington, D.C.—The Council for Responsible Nutrition (CRN) has responded to FDA’s November 2021 letter regarding CRN’s citizen petition on NAC. Background: As WholeFoods has previously reported, FDA issued warning letters in July 2020 asserting that NAC has been previously approved as a drug in 1963, and therefore is not a...
Houston, TX—COVID-19 patients have high levels of oxidative stress and damage, and markedly reduced levels of glutathione, according to a new study from researchers at Baylor College of Medicine. The results, published in Antioxidants, were found by comparing 60 patients hospitalized with COVID-19 to healthy age-matched individuals whose samples were...
Washington, D.C.—The Natural Products Association (NPA) announced that it has filed a lawsuit against the Food and Drug Administration (FDA). At issue: the status of N-acetyl-L-cysteine (NAC). NPA is requesting that FDA "cease its unlawful retroactive application of the Food, Drug, and Cosmetic Act" against NAC. As WholeFoods has previously...
Washington, D.C.—The Council for Responsible Nutrition (CRN) has expressed disappointment with FDA’s response to its citizen petition about the status of N-acetyl-L-cysteine (NAC) as a legal dietary supplement. The petition, as WholeFoods previously reported, was filed in June 2021 following several meetings with FDA leadership. While NAC has been marketed...
Silver Spring, MD—The American Herbal Products Association (AHPA) announced that it has joined the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) in calling on the Food and Drug Administration (FDA) to clarify that N-acetyl cysteine (NAC) is a lawful dietary ingredient. As WholeFoods previously reported, despite decades...
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...
About three decades ago, I was one of the food-and-drug attorneys involved in defending various persons and companies who for some time had been distributing an amino acid called GHB (gamma hydroxybutyrate), which although sold as a dietary supplement, had three remarkable characteristics: It helped users quickly fall asleep; It...
