CRN Asks FDA: “Remove Impasses to Longstanding Issues; Promote Innovation by Protecting Intellectual Property”

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College Park, MD—On May 16, FDA held a public meeting titled “Responsible Innovation in Dietary Supplements.” The meeting was intended to give interested parties an opportunity to present ideas for maintaining FDA’s ability to protect the public while encouraging responsible innovation within the Industry. A full list of presentations can be found here.

The deadline for submitting comments regarding the meeting was July 15. The Council for Responsible Nutrition (CRN) has shown WholeFoods their comments, in which they urge FDA to “remove impasses to longstanding issues regarding permissible dietary ingredients, facilitate industry’s understanding of NDI notification requirements, and promote innovation by protecting the intellectual property of those that invest in science to bring new ingredients to the market using the NDI notification process as intended by DSHEA,” all with the goal of modernizing FDA’s approach to regulation.

CRN holds that “dietary ingredients” is a wider scope than FDA is acknowledging, and includes synthetic copies of botanical constituents as long as the two are chemically equivalent. CRN also asks that FDA include ingredients that existed in dietary supplements pre-DSHEA to be considered as “present in the food supply,” and thus excluded from the NDI notification requirement.

CRN further notes that lack of intellectual property protection, regulatory enforcement, and clarity regarding what constitutes an NDI have hindered innovation, suggesting, among other things, an NDI Master File that would help identify ingredient-specific safety information, such that a branded ingredient’s science could not be reused to ‘prove’ the safety of an unbranded version. It would allow FDA to swiftly identify marketers of NDIs that were not properly notified.

CRN concludes that all of this is predicated on the assumption that FDA will enforce its own rules, and urges it to “avail itself of all the enforcement tools it has the authority to use.”

CRN added that they were looking forward to working with FDA on all of this in the future.

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