Federal Oversight For Plaintiff Lawyer Advertising | Drug & Device Law

We write mostly about decisions in cases, with those mostly coming from judges. Occasionally, we will also comment on articles, amicus briefs, and official government pronouncements. We cannot remember the last time we explored a press release. In today’s political environment, speculation about what is contained in documents that purportedly exist but we cannot see can be time-consuming and often pointless...

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FDA Issues First Mandatory Recall Order, Exercising FSMA Authority Over Food Products Containing Kratom

On April 3, 2018, FDA announced[1] that it had issued a mandatory recall order for all food products containing powdered kratom manufactured, processed, packed, or held by Triangle Pharmanaturals LLC (Triangle). FDA issued this order based on its finding that several Triangle products contained kratom that tested positive for salmonella.   FDA issued the order after the company failed to respond...

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Despite Deadly Outbreak, FDA Cannot Recall Drugs

Health Letter[1], March 2017 By Sarah Sorscher, J.D., M.P.H. In January, the murder trial began for Barry J. Cadden, former pharmacist, president and co-owner of now-shuttered New England Compounding Center. Cadden was charged with second-degree murder[2] for his role in producing contaminated drugs that led to a nationwide fatal fungal meningitis outbreak in 2012. The 2012 outbreak, which sickened more...

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