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Align Supplement Industry Regulation With DSHEA, Groups Tell FDA In 'Responsible Innovation' Comments

Executive Summary

Targeted guidance on questions around NDINs and using import alerts to keep violative products off market are among supplement industry trade groups' suggestions for improving FDA oversight of the industry. Groups also continue asserting that the agency can strengthen its VMS product manufacturing and marketing oversight with its existing authorities.

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Drug Innovation Needs Exclusivity For Some Natural Substances, PhRMA Recommends

In comments on VMS industry oversight, PhRMA recommends FDA adhere to clear regulations that determine whether substances are eligible for use as dietary ingredients. DSHEA makes clear that some dietary ingredients are not eligible for use VMS products.

'Innovation' Meeting Shows FDA-Industry Gap On NDI Guidance Details Remains

Panel discussions and public comments during FDA public meeting show industry sees agency, as it stated in draft NDI notification guidances published in 2011 and 2016, is allowing little room for innovation through making new ingredients available for use in VMS products. FDA says immense growth of the VMS market since DSHEA passed shows numerous products available in US contain substances that haven't been notified to the FDA with proof showing they are dietary ingredients and are safe for use.

Degree Of Difficulty Could Climb For Industry's NDI Investments To Continue

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