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Update on Revised NDI Guidance

It remains unclear when FDA will issue its revised NDI guidance, but industry groups and members of Congress continue to put pressure on the agency to take action. “In a July 9 letter to Commissioner Margaret Hamburg, 18 House members said they ‘encourage the agency to continue its efforts to bring clarity to’ NDIs.”  This congressional letter follows an April 2013 letter from AHPA, NPA and other trade associations which asked “FDA to issue a draft guidance document focusing on identity information for NDI notifications.”

In addition to seeking more clarity on identifying ingredients, other issues that industry groups hope to resolve include whether NDI notifications (NDINs) should be submitted when a firm changes its manufacturing process or the ratio of ingredients.  Industry groups had also pressed for not listing manufacturing processes that would cause an ingredient to be “chemically altered”; however, in recent remarks, Dan Fabricant indicated that the next draft guidance is likely to include such a definition.  Dr. Fabricant also focused on the purpose of the NDINs – to “show a supplement product containing the subject ingredient has a reasonable expectation of safety, not that an ingredient is safe for use in any supplement formulation.”

Please stay tuned to our blog for more updates on when the revised NDI Guidance will be released and what it is likely to include.

* Our gratitude is extended to “The Tan Sheet” (July 15, 2013) for providing the content for this post.