Drugs

Court OKs FDA Injunction Against Grandma’s Herbs

The Utah federal court has entered a consent decree of permanent injunction between the U.S. government, through FDA, and Grandma’s Herbs, St. George, UT, and its owners, Kevin and Tracey Parr. An FDA news release says the company manufactured and distributed products marketed as dietary supplements with labeling that rendered them unapproved and misbranded new drugs.

“FDA has not approved Grandma’s Herbs’ products for any use, despite the company’s claims that its products could be used to diagnose, cure, mitigate, treat, or prevent conditions such as respiratory tract infections, ulcers, heart disease, autoimmune disorders, and epilepsy,” the release says. “The consent decree prohibits the defendants from, among other things, directly or indirectly manufacturing or distributing such products until certain requirements are met.”

A 2017 Warning Letter indicated that an agency review of the firm’s Web site found that many of its products are not dietary supplements but rather are unapproved and misbranded new drugs.

The decree prohibits Grandma’s Herbs from marketing such products until the company, among other things, hires a labeling expert, removes its products’ violative labeling, and receives written permission from FDA to resume operations.

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