Sharpless On FDA's Dietary Supplement Regulation Reform: It's 'Complicated'
"I look forward to beginning a productive dialogue about reshaping our oversight of these products," acting FDA Commissioner Norman Sharpless said recently about agency's public meeting on May 16. Access to meeting at CFSAN headquarters opens at 8 a.m. and irst of four sessions on questions center stated in meeting notice begins at 9 a.m. Each discussion followed by question and answer sessions and public comments scheduled for 3 p.m.
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In his first speech to agency staff, Acting Commissioner Norman Sharpless says FDA will continue working on issues including food safety and nutrition drug, and he is not approaching the post like a temporary caretaker. Sharpless said his appointment does not reflect attempt by President Trump or HHS Secretary Alex Azar to force FDA to change direction set by Scott Gottlieb.
FDA's notice for a May 16 public meeting say it intends to ensure its "regulatory framework is flexible enough to adequately evaluate product safety without unnecessarily restricting innovation." But FDA makes clear adherence with its NDI notification requirement is focus of the spurring improvement in VMS product industry's overall compliance with regulatory framework established by DSHEA.
USPlabs executives, others plead guilty to felony charges stemming from marketing unsafe products labeled as supplements but containing DMAA and linked to hepatitis. Blackstone Labs and other firms indicted on felony charges following FDA investigation for marketing DMBA-containing products. "It's all very welcome news, but I'm not sure this is going to change the overall environment," says Pieter Cohen, a physician who advocates for tighter regulation of supplement manufacturing and marketing.