FDA Policy/General

Two Ex-Supplement Marketers Sentenced to Prison

The northern Texas federal court has sentenced two former dietary supplement company executives to prison and ordered two companies to pay a combined $10.7 million in criminal forfeiture for their roles in fraudulently selling popular workout supplements. Former USPlabs CEO Jacobo Geissler (University Park, TX) was sentenced to 60 months’ imprisonment, and former USPLabs president Jonathan Doyle (Dallas, TX) was sentenced to 24 months, according to a Justice Department release. The court previously sentenced USPlabs to pay $4.7 million in criminal forfeiture, and sentenced SK Laboratories to forfeit $6 million in connection with the case.

The defendants were involved in the manufacturing and marketing of the popular workout and weight loss supplements known as Jack3d and OxyElite Pro, which were distributed by USPlabs. As part of their guilty plea last year, Doyle and Geissler admitted that they imported substances with false and misleading labeling to avoid law enforcement and regulatory agency attention, the Justice release says. Products were recalled in 2013 in the wake of an FDA investigation into whether the supplement caused liver injuries in consumers. The government’s indictment alleged that the defendants sold some of their products without determining whether they would be safe to use.

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