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McCain-Dorgan NDI Guidance, Steroid Provisions In Senate Food Safety Bill

This article was originally published in The Tan Sheet

Executive Summary

Requirements that benefit dietary supplement manufacturing and that gained Sen. John McCain's support after he initially proposed legislation considered a threat to the industry are part of the food safety reform bill pending in the Senate.

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FDA NDI Draft Is A Push For Tighter Supplement Regulation – Stakeholders

FDA proposed “a pretty crazy” NDI notification draft guidance, says attorney Wes Siegner, because “they think everything is an NDI.” Other stakeholders acknowledge FDA wants tighter regulation of the industry, but say writing and imposing rules for supplement manufacturing is a two-way street.

FDA NDI Draft Is A Push For Tighter Supplement Regulation – Stakeholders

FDA proposed “a pretty crazy” NDI notification draft guidance, says attorney Wes Siegner, because “they think everything is an NDI.” Other stakeholders acknowledge FDA wants tighter regulation of the industry, but say writing and imposing rules for supplement manufacturing is a two-way street.

Hatch, Harkin Call For Withdrawal of NDI Draft Guidance

Sens. Hatch and Harkin ask FDA to craft a new document to replace the current NDI notification draft guidance, recommending the agency “provide needed clarification” on what constitutes an NDI.

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