Drugs

China Business Owner Sentenced in Supplement Scheme

A Shanghai, China business owner has been sentenced in Dallas to 18 months imprisonment and one year of supervised release in connection with a scheme to sell mislabeled dietary supplements. Xu Jia Bao (aka Fred Xu) is the principal of Shanghai Waseta International Trade Co. Ltd., a Chinese firm that sells raw ingredients for use in dietary supplements. Xu pleaded guilty 8/2018 in the Northern District of Texas to one count of wire fraud, according to the Justice Department. His company also pleaded guilty to wire fraud in September 2018. The company was sentenced in February to one year of probation and ordered to pay a $500,000 fine.

As part of his guilty plea, Xu admitted that he agreed with others working at Waseta to sell synthetic stimulant ingredients, including the substance known as DMHA, to a purported dietary supplement manufacturer in the U.S. According to the government, Xu admitted that the purported dietary supplement manufacturer, actually a confidential government informant, told him that Waseta ingredients would not be accurately listed on the labels of the finished dietary supplement. Xu admitted that he knew major American retailers would refuse to carry supplements known to contain certain stimulants, such as DMHA. Xu also admitted that he and Waseta caused a falsely labeled shipment of DMHA to be sent to Texas.

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