Drugs

Is NAC a Drug or a Dietary Supplement?

The dietary supplement industry reportedly is concerned about recent Warning Letters to several dietary supplement manufacturers that said N-acetylcysteine (NAC) is excluded from the definition of a dietary supplement because it was first approved as a drug in 1963. Natural Products Insider says in an online post that the Warning Letters went to several marketers of supplements for hangover cures.

The post also notes that NAC is included in several research studies as a potential treatment for Covid-19.

According to the post, some 1,170 products containing NAC were listed in the Dietary Supplement Label Database maintained by the National Institutes of Health.

“This is not a fringe ingredient,” Council for Responsible Nutrition CEO Steve Mister told the newsletter in an interview. He said that since the Warning Letters were issued, several members of the council have asked whether they should be concerned and whether FDA will be targeting products containing NAC.

FDA Office of Dietary Supplement Programs director Steven Tave told Natural Products Insider that the letters merely reiterate the agency’s previous conclusions that NAC is excluded from the definition of a supplement. “To the extent that any stakeholders and anyone in industry or anyone else have facts that they think would cause us to rethink our conclusion, then we would welcome that evidence. We’re happy to review it and we would invite them to submit it to us.”

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