(July 26, 2007) — The American Herbal Products Association (AHPA) yesterday submitted a Petition for Reconsideration to the Food and Drug Administration (FDA) to request that the agency reconsider and amend seven specific elements in the final rule on current good manufacturing practice for dietary supplements that was published on June 25, 2007.

The Petition addresses issues that AHPA members, staff and general counsel have identified as either potentially confusing, contrary to the public interest, or that might be damaging to dietary ingredient manufacturers with no corresponding benefit. The Petition was submitted under the FDA rule that applies the Administrative Procedures Act’s requirement for all federal agencies to “give an interested person the right to petition for issuance, amendment, or repeal of a rule.” Any decision to accept or reject any such petition is at the sole discretion of the FDA Commissioner.

AHPA’s Petition includes requests for FDA to:

1. Clarify that a dietary ingredient manufacturer or supplier cannot be made subject to the final rule based on how its customers use its ingredients.
2. Remove a potential loophole that would allow companies that package products made by someone else to avoid some parts of the rules on verifying that product specification are met.
3. Add definitions for the terms “manufacturing,” “packaging,” “labeling,” and “holding.”
4. Allow master manufacturing records to include a range of batch sizes, rather than be limited to a specific batch size.
5. Remove language that would have the effect of barring any single-employee companies from being in the dietary supplement business, and replace it with appropriate options that will ensure product quality even in such small firms.
6. Allow personnel to conduct examinations for correct labels (this is now limited to electronic or electromechanical examination) to qualify for an exemption to label reconciliation.
7. Require that the batch, lot or control number that must be assigned to dietary supplements actually appears on finished products.

“AHPA believes that these are all reasonable requests and hopes that FDA accepts them as such,” commented AHPA’s president, Michael McGuffin. “At the same time, AHPA members should be focused on implementing the final rule as published, especially those companies with over 500 employees who must be in compliance by next June.”

The AHPA petition is available on the AHPA website at http://www.ahpa.org/Portals/0/pdfs/07_0725_AHPA_cGMP_Petition.pdf.