Drugs

Web Site Selling ‘Essential Oils’ as Covid Treatment: FDA, FTC

FDA and the Federal Trade Commission say that the Web site www.organic-beauty-recipes.com is participating in the Amazon Associates program that pays the site owners a commission for promoting the sale of essential oil products. A 6/8 Warning Letter says the agencies’ review of the Web site found claims that the Amazon Associates products can mitigate, prevent, treat, diagnose, or cure Covid-19 in people. FDA says the products are unapproved and misbranded.

“We request that you immediately cease promoting and participating in the sale of such unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of Covid-19,” the letter says.

The Web site owners were told to take immediate action to correct the violations cited in the letter and to respond by e-mail with a list of specific steps taken to correct the violations and documentation of each step.

The letter also notes that it is unlawful under the FTC act to advertise a product that can prevent, treat, or cure human disease unless the advertiser possesses competent and reliable scientific evidence including, when appropriate, well-controlled human clinical studies, substantiating that the claims are true at the time they are made. “For Covid-19, no such study is currently known to exist for the product identified above,” it says. The company was told to respond to FTC with a description of specific actions taken to address that agency’s concerns.

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