Drugs

Petition Wants NAC Declared Legal Dietary Ingredient

The Natural Products Association is petitioning FDA to acknowledge NAC (N-acetyl-L-cysteine) as a legal dietary ingredient. A Nutraingredients.com online post says the molecule, a derivative of the L-cysteine amino acid and a precursor of the cellular antioxidant glutathione, has been on the market for decades and was ruled violative last year by FDA.

“Despite its early use as a respiratory medication,” the post says, “the ingredient has been widely used for many years in finished dietary supplements, frequently as a standalone product.” It says it has found 1,442 products containing NAC.

The post says FDA must have been aware of the ingredient being on the market in supplement form for decades and took no action on its status until the summer of 2020 when it sent seven Warning Letters to companies making hangover remedies, which the agency said was illegal disease treatment. In the letters, FDA said NAC was an illegal dietary ingredient because of its prior investigation as a drug.

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