Supplement Industry Stays On FDA’s Radar with New Draft Guidance for “New Dietary Ingredients” In Supplements
Insight Dennis E. Raglin · September 16, 2016
In this article, posted on Nutraingredients-USA, Dennis Raglin discusses FDA's new actions against dietary supplements containing ingredients with potential health risks to the public.
This action follows the release of an August 11, 2016 revised draft guidance designed to improve the new dietary drug ingredient (NDI) premarket notification process, “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.” These notifications are supposed to assist FDA in identifying safety concerns in these products before they are sold to consumers. In addition to giving direction on whether and when to submit premarket safety notifications for new dietary ingredients, or for dietary supplements that contain an NDI, the draft provides specifics on what the agency expects to see in the premarket notification to better address consumer health. Access the full article here