AHPA urges FDA to maintain exemption from 100 percent identity testing

AHPA urges FDA to maintain exemption from 100 percent identity testing

Published: Tuesday, December 30, 2014

The American Herbal Products Association (AHPA) urged the FDA to maintain the exemption from the 100 percent identity testing of dietary ingredients under current good manufacturing practice (cGMP) requirements for the manufacture of dietary supplements.

AHPA submitted comments in response to FDA's Federal Register notice issued November 28 that announced a proposed collection of information has been submitted to the Office of Management and Budget (OMB) in relation to the Petition to Request an Exemption from 100 Percent Identity Testing of Dietary Ingredients.

In the November 28 notice, FDA states that it has not received any new petitions to request an exemption from 100 percent identity testing of dietary ingredients in the last three years.

"If there have been no petitions received to date it may be that FDA's stated goal 'of providing flexibility in the cGMP requirement' has not been met and that dietary supplement manufacturers may not have been provided with the 'potential relief' outlined in the regulations," said AHPA President Michael McGuffin.

In spite of this non-use to date, AHPA continues to believe that it is important to maintain this possible exemption to 100 percent identity testing in order to provide regulatory flexibility and encourage supplement companies to identify and implement systems of less than 100 percent identity testing that would result in no material diminution of assurance of the identity of the dietary ingredient as compared to the assurance provided by 100 percent identity testing.

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