AHPA urges revisions to GMP final rules

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AHPA urges revisions to GMP final rules
October 2007
Chiropractic Economics

The American Herbal Products Association (AHPA) is encouraging the Food and Drug Administration (FDA) to allow suppliers the option of submitting petitions to FDA, so their customers could be exempted from 100-percent identity testing under the final rule on current good manufacturing (cGMP) rules for dietary supplements.

This request was one of several points the trade association made in comments submitted to FDA regarding an interim final rule (IFR) that proposes a mechanism for such petitions. The IFR was published in June, at the same time as the final cGMP rule.

As currently written, supplement manufacturers, but not ingredient suppliers, may submit petitions for exemptions from the cGMPÌs requirement that manufacturers conduct at least one appropriate test or examination to verify the identity of each dietary ingredient used in their products.

Under the interim final rule, these petitions would need to include scientific support for proposed alternative testing and/or examinations that demonstrate there is no material diminution of assurance of the identity of the ingredient.

ÏAHPA is requesting that FDA provide some flexibility in the mechanisms that can be used to address the essential step of assuring ingredient identity, and has presented a proposal that will be both more efficient and more effective in meeting this need,Ó said AHPA President Michael McGuffin.

AHPAÌs comments, which include a draft revision of the IFR that incorporates many of its suggestions, are available on the associationÌs Web site, www.ahpa.org.