AHPA Urges FDA to Revise its cGMP Alternative Identity Testing Petition Process

(October 24, 2007) — 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 was just one of several points the trade association made in comments submitted to FDA today on an interim final rule (IFR) that proposes a mechanism for such petitions, but that would limit these to supplement manufacturers. 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 cGMP’s 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.

“AHPA 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,” said AHPA President Michael McGuffin. “Importantly, AHPA supports FDA’s position that petitions for exemptions to 100 percent identity testing should only be granted when the described alternative identity testing ensures that there is no reduction in the degree of certainty of an ingredient’s identity.”

Other points that AHPA raised include:

♦ Suggestions on the minimum required information and additional optional information that a petition for an exemption to 100 percent identity testing should include.

♦ A request that FDA accept alternative identity testing petitions in advance of the cGMP’s compliance dates over the next three years.

♦ A discussion of AHPA’s belief that a citizen petition is not the best mechanism to petition for an exemption to 100 percent identity testing.

♦ AHPA’s belief that FDA’s assumption that statistical analysis is needed to support an exemption request is burdensome and unnecessary.

♦ Specific recommendations for timelines for FDA responses to alternative identity testing petitions.

♦ A request that FDA issue guidance on this regulation at the earliest opportunity.

AHPA’s comments, which include a draft revision of the IFR that incorporates many of its suggestions, are available on the association’s website at: http://www.ahpa.org/Portals/0/pdfs/07_1024_AHPAComments_GMP_IFR.pdf.


The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Celebrating our 25th anniversary in 2007! Website: www.ahpa.org.

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