Drugs

FDA Warns 7 Supplement Companies About CV Claims

FDA has warned seven dietary supplement manufacturers that they are illegally selling products that claim to cure, treat, mitigate, or prevent cardiovascular disease or related conditions such as atherosclerosis, stroke, or heart failure. An agency notice says FDA is urging consumers not to use these or similar products because they have not been evaluated by the agency to be safe or effective for their intended use and may be harmful.

The letters went to Essential Elements, Calroy Health Sciences, Iwi, BergaMet North America, Healthy Trends Worldwide, Chambers’ Apothecary, and Anabolic Laboratories.

Under the Federal Food, Drug, and Cosmetic Act, the notice says, products intended to diagnose, cure, treat, mitigate, or prevent disease are legally considered to be drugs and are subject to the requirements that apply to drugs, even if they are labeled as dietary supplements, FDA says.

The companies were told to respond with actions they will take to address the issues in the Warning Letters or by providing their reasoning and supporting information as to why they think their products do not violate the law.

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