Drugs

Reverse Dietary Supplement NAC Ban: Petition

The Council for Responsible Nutrition (CRN) has petitioned FDA to reverse its recent position that the Federal Food, Drug, and Cosmetic Act prohibits manufacturers from marketing products containing N-acetyl-L-cysteine (NAC) as dietary supplements. “The policy, which represents a sudden and drastic departure from past agency practice, is legally invalid,” the 6/1 petition says. “FDA should revert to its longstanding policy of allowing manufacturers to market products containing NAC as dietary supplements.”

The petition says CRN has discussed NAC with the agency since 2020 and has met with various officials, including acting commissioner Janet Woodcock. It says FDA has indicated that it is considering CRN’s position but has given no firm timeline for a response. CRN says it has stressed the need for a quick resolution given marketplace reliance on FDA public statements.

“While FDA reviews the legality of its policy reversal,” the petition says, “NAC supplement manufacturers are experiencing significant negative economic impacts.” CRN says formal action is needed through the citizen petition process to put a 180-day deadline on the agency response or face potential court action.

Gupta Raises Concerns About Overton’s Independence, Ideology

FDA commissioner nominee Heidi Overton’s responses on vaccines, contraception and abortion medication during her 9/24 Senate confirmation hearing raise concerns that ideology could influence her decision-making if she takes over the agency, MSNBC senior medical analyst Dr. Vin Gupta said Friday. Gupta was particularly critical of Overton’

Overton Confirmation Remains Uncertain After Senate Hearing

FDA commissioner nominee Heidi Overton emerged from her Senate confirmation hearing Thursday (see earlier story) without resolving questions about whether she has enough Republican support to advance — and with a rapidly narrowing window for confirmation before the midterm elections. The Senate Health, Education, Labor and Pensions Committee hearing provided few

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA has classified Boston Scientific's recall of its Imager II Angiographic Catheters as Class I because a manufacturing problem could cause catheter tips to degrade and detach, potentially resulting in life-threatening complications. The agency announced the Class I classification 9/25, updating an Early Alert it issued

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome

FDA has approved Roche’s Gazyva (obinutuzumab) for reducing the risk of relapse in adults and children aged 2 and older with frequently relapsing or steroid-dependent, childhood-onset idiopathic nephrotic syndrome who are in remission. The expanded approval covers the use of the CD20-directed antibody beyond its existing

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome