Drugs

FDA Mulls Enforcement Discretion on NAC Products

FDA says that it is considering exercising enforcement discretion for N-acetyl-L-cysteine (NAC)-containing products labeled as dietary supplements. But for the time being, the agency says it is still reviewing the issue and it denied two citizen petitions from the Council for Responsible Nutrition and the Natural Products Association (NPA) that asked it to determine that products containing NAC are not excluded from FDA’s definition of a dietary supplement. The agency says it intends to issue guidance about its policy on NAC-containing products labeled as dietary supplements in the near future.

In a just-posted letter to constituents, FDA says that while its response to the citizen petitions confirmed NAC is excluded from the definition of a dietary supplement, “the agency has not yet reached a decision on the NPA citizen petition’s alternative request that the agency undertake rulemaking to allow the use of NAC in dietary supplements. The FDA continues to review this request.”

The dietary supplement industry reportedly is concerned about recent Warning Letters to several dietary supplement manufacturers marketing them as hangover cures. These letters said NAC is excluded from the definition of a dietary supplement because it was first approved as a drug in 1963. Some 1,170 products containing NAC were listed in the Dietary Supplement Label Database maintained by the National Institutes of Health.

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