Marian Zboraj10.25.07
The American Herbal Products Association (AHPA), Silver Spring, MD, has encouraged the Food and Drug Administration (FDA) to allow suppliers the option of submitting petitions to FDA so their customers could be exempted from 100% 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 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% 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:
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% 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% 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% 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.