NDI Draft Guidance: Perceptions, Needs & Strategy

On July 5, 2011, FDA published its much-anticipated “Draft Guidance for Industry: New Dietary Ingredient (NDI) Notifications and Related Issues,” which immediately raised concerns within the dietary supplement industry related to issues such as dietary supplement notification, synthetic ingredients, changes in manufacturing processes and more. INSIDER fielded an online questionnaire on the draft guidance to the supplement community in September 2011, asking about their understanding of the guidance and key areas of concern.

What is the level of familiarity with the Draft Guidance?
Top concerns include cost of compliance and defining an "old" ingredient
Does the Draft Guidance follow the language and intent of DSHEA?

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About the Author

Heather Granato is the group editorial director, Health & Nutrition Network, VIRGO. With more than 19 years experience in the natural products industry, she oversees the content strategies for the Natural Products INSIDER, Food Product Design, Inside Cosmeceuticals and Integrative Healthcare Insider brands.