US FDA/CFSAN - Implementation of FDA's Current Good Manufacturing Practices for Dietary Supplements
October 24, 2007
IFR
- Manufacturers may use one petition to request an exemption from 100 percent identity testing for one or more dietary ingredients and one or more suppliers;
- The petition needs to provide data and information that are specific to each dietary ingredient and each supplier.
- If the manufacturer changes dietary ingredient(s) or supplier(s), or any other combination thereof, FDA's approval would not apply to the particular changed dietary ingredient