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WASHINGTON — The Consumer Healthcare Products Association and the Council for Responsible Nutrition on Friday jointly filed comments with the Food and Drug Administration seeking withdrawal of its New Dietary Ingredient Draft Guidance, and calling upon the agency to work with stakeholders on a revised version that will maintain the current scope and intent of the Dietary Supplement Health and Education Act of 1994.
The submission noted that the agency’s proposed guidance would impose significant and unnecessary new burdens on the dietary supplement industry without conferring additional benefits to consumers. “We had hoped [the] FDA would propose a reasonable guidance related to new dietary ingredients, but this guidance goes far beyond what Congress authorized under the Dietary Supplement Health and Education Act of 1994,” stated CHPA President and CEO Scott Melville. “Rather than developing standards and a process for new dietary ingredients in accordance with DSHEA, this guidance would impose significant new burdens that would impact consumer access to dietary supplements as well as reduce innovation and growth of this industry.”
“The draft guidance essentially would undo nearly two decades of agency practice and policy that began with DSHEA’s passage," added CRN president and CEO Steve Mister. "CRN and others in the industry have been calling on [the] FDA to provide clarity through this draft guidance, and responsible industry fully supports a reasonable guidance that provides directions for filing NDI notices within the legal framework of DSHEA. However, this guidance does not answer that call.”
The joint comments highlighted five areas of concern, including the draft guidance’s requirement of notifications for individual supplements by each manufacturer rather than for the ingredient — a process that, if realized, would result in duplicative and unnecessary notifications.