Drugs

Nature City Settles FTC Claims for $537,500

The Federal Trade Commission (FTC) says Nature City, Boca Raton, FL, which markets two aloe vera-based supplements, has agreed to pay $537,500 to settle charges that it deceived consumers with false and unsupported claims that its TrueAloe and AloeCran were effective treatments for a range of conditions affecting older citizens, including chronic pain, ulcerative colitis, diabetes, and acid reflux.

A Florida federal court order sought by FTC and approved by the court bars the company from making false and unsubstantiated health claims and says FTC can use the company payment to provide refunds to defrauded consumers. The order also requires the company to disclose any material connection it has with compensated product reviewers.

The commission says that since 5/2002, the company and two of its officers marketed and sold the products primarily through direct mail to consumers nationwide. It says the products’ health claims were deceptive and not supported by competent and reliable scientific evidence. FTC also alleges that the company used testimonial reviews from seemingly independent users and failed to disclose that the reviewers received free products or free lifetime memberships as compensation for providing the reviews.

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