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CRN Urges FDA to Reverse Synthetic Botanicals Position

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By: Sean Moloughney

Editor, Nutraceuticals World

The Council for Responsible Nutrition (CRN), Washington, D.C., has called on FDA to reverse its current position that synthetic constituents of botanicals cannot be dietary ingredients. In a letter to FDA Commissioner Margaret Hamburg, MD, CRN said the agency’s position is contrary to the congressional intent behind the Dietary Supplement Health and Education Act of 1994 (DSHEA), stands in stark conflict with decades of FDA precedent, and is neither scientifically justified nor in the interest of the public health. 

Further, CRN president and CEO Steve Mister requested that this issue be resolved without having to wait for resolution on other aspects of the New Dietary Ingredient (NDI) Draft Guidance, given the association’s concern that FDA has recently increased enforcement activities related to synthetic botanical constituents. “Because such enforcement actions are not grounded in the law, they exceed FDA’s statutory authority and must be ceased,” Mr. Mister wrote. “FDA’s actions and comments are having an immediate chilling effect on the industry and are irrevocably damaging commerce, innovation and investment.” 

Despite ongoing discussions between the industry and FDA on other aspects of the NDI Draft Guidance, FDA’s district offices and port inspectors continue to detain ingredients at the border, issue warning letters to manufacturers, request recalls and threaten seizures of synthetic botanical constituents, and to allege they are not legitimate dietary ingredients. “CRN asks FDA to reverse its position, to cease taking or threatening enforcement action against synthetic botanical constituents, and to stop asserting…that such substances are not lawful dietary ingredients,” Mr. Mister concluded.

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