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ODSP director ticks through industry report card

By Published On: June 20, 20244.1 min readViews: 1090 Comments on ODSP director ticks through industry report card
So how is the industry doing 30 years after the passing of the Dietary Health and Education Act of 1994? Is it complying with the statute? Is there room for improvement?

Before launching into a rapid-fire series of slides, Dr. Welch reminded industry that her office, which currently sits within Center for Food Safety and Applied Nutrition (CFSAN) at the Food and Drug Administration (FDA), sets the policies and programs for FDA’s oversight of dietary supplements. This includes providing guidelines, regulations, safety assessments and compliance strategy.

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Always at the center of its strategic priorities, she emphasize, is consumer safety.

“The products should be what they say they are, contain what they say they contain, only in the amount that they say they contain,” she said, adding that informed decision-making at all levels from manufacturer to consumer is also key.

For the report card, she focused on scoring three main areas: new dietary ingredient notification requirements, good manufacturing practices and structure-function claim notifications.

New dietary ingredient notifications

New dietary ingredient (NDI) notifications are FDA’s only premarket review opportunity for dietary supplements. NDIs are defined as those not marketed prior to Oct. 15, 1994 or present in the food supply.

Published in 1997 to enable industry to comply with DSHEA, the requirement for NDI notification is codified in 21 CFR 190.6​. It establishes that a manufacturer or distributor of dietary supplements containing a new dietary ingredient submit a safety notification at least 75 days prior to marketing.


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