Drugs

Multiple Violations at Herbal Healer Academy

An 11/5-11/9/18 FDA inspection at Herbal Healer Academy, Mountain View, AR, found multiple violations of the Federal Food, Drug, and Cosmetic Act, according to a 9/12 Warning Letter. The letter first says the company takes orders for products that are listed with health claims on the firm’s Web site and in its catalog. FDA says the products are considered to be unapproved new drugs and misbranded drugs.

The letter also cites the company for misbranded homeopathic drugs and adulterated dietary supplements. It notes that during the inspection, investigators observed these significant violations of current good manufacturing practice guidelines for dietary supplements:

failing to collect and hold reserve samples of each lot of packaged and labeled dietary supplements that the firm distributes; and
failing to establish and follow written procedures to fulfill requirements related to returned dietary supplements.

The letter says that two of the firm’s dietary supplements would be misbranded even if they did not have therapeutic claims making them unapproved new drugs.

Herbal Healer was told to respond with a list of specific steps taken to correct the violations, with documentation of each step and a schedule for implementation and completion.

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