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So much for lazily easing into summer. July had barely begin when the Food and Drug Administration (FDA) dropped a bombshell on the dietary supplements industry the day before Independence Day with the publication of its long-awaited draft guidance on new dietary ingredients (NDIs) ... Now it might sound pretty innocuous, but this document certainly ruined a few July 4 holiday weekends, and could have apocalyptic ramifications for the trade if some commentators are to be believed. While the FDA’s Dan Fabricant insisted it contained few surprises, trade associations and food law attorneys alike warned it could prove catastrophic unless Fabricant et al are prepared to countenance some pretty radical revisions. Click here for Herbalife’s Vasilios Frankos’ take on the guidance. Click here for Marc Ullman’s view at Ullman, Shapiro & Ullman; click here for Alan Feldstein’s view at Collins, McDonald & Gann, click here for Scott Bass’s take at Sidley Austin and here for Wes Siegner’s view at Hyman, Phelps & McNamara. Click here for Dan Fabricant’s spirited defense of the document. Click here for a perspective from Mark Blumenthal at the American Botanical Council and click here for a toxicologist’s view. Click here for Steve Mister’s reaction at the Council for Responsible Nutrition. |
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