Supplement Pre-market Approval Resurfaces From Blumenthal, Durbin
This article was originally published in The Tan Sheet
Sen. Blumenthal plans a floor amendment to the FY17 National Defense Authorization Act to require third-party verification for supplements sold at retail establishments on US military posts. The amendment likely would have support from Sen. Durbin, who joined Blumenthal in introducing a similar amendment in 2015.
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PharmaTech customers recall liquid supplements, including products indicated for children, after CDC informs FDA that an antibiotic-resistant pathogen was found in a PharmaTech Rx drug. CRN says the recall should remind supplement firms about tracking supply chains and auditing contract manufacturers.
Health Canada says its planned overhaul will not scrap the current natural health product framework, but industry is skeptical. In a Council for Responsible Nutrition webinar, an industry consultant says marketers of OTC drugs, supplements and cosmetics are discussing the proposal's negative implications with the agency.
Gottlieb is not the first FDA commissioner nominee to profess support for its regulatory framework established by DSHEA, but the focus of Hatch's question serves stronger notice than similar questions asked of previous candidates that the agency authority to enforce in the space does need adjustment.