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In US, Market Exclusivity For NDI Notifications ‘Just Not There’ In DSHEA Regulation

 
• By Malcolm Spicer

Unfounded expectation some firms have for FDA to protect their investments in preparing successful NDI notifications is part of industry’s overall interest in increased regulation of the market, says Steven Tave, Office of Dietary Supplement Programs director.

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Dietary supplement marketers don’t have support in the US law that established the Food and Drug Administration’s regulatory framework for oversight of the industry to claim market exclusivity for new dietary ingredients, says the agency’s head of enforcement for the market.

The apparent expectation some firms have for the agency to protect their investments in preparing successful new dietary ingredient notifications...

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