FDA Policy/General

FDA Warning on Miracle Mineral Solution

FDA has issued a warning against Miracle Mineral Solution (MMS) because it is illegally promoted as a remedy for treating autism, cancer, HIV/AIDS, hepatitis and flu, among other conditions. “However, the solution, when mixed, develops into a dangerous bleach which has caused serious and potentially life-threatening side effects,” the warning says. “The FDA will continue to track those selling this dangerous product and take appropriate enforcement actions against those who attempt to evade FDA regulations and market unapproved and potentially dangerous products to the American public.”

FDA says that Web sites selling MMS describe the product as a liquid that is 28% sodium chlorite in distilled water. Product directions instruct consumers to mix the sodium chlorite solution with citric acid – such as lemon or lime juice – or another acid before drinking. When the acid is added, the mixture becomes chlorine dioxide, a powerful bleaching agent. New reports have been received about people becoming violently ill after ingesting it, the agency adds.

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