July 2007

AHPA petitions FDA to reconsider parts of cGMP

The American Herbal Products Association (AHPA) recently submitted a petition to the Food and Drug Administration (FDA), requesting the agency to reconsider and amend seven specific elements in the final rule on current good manufacturing practices (cGMP) for dietary supplements published June 25.

The petition addresses issues 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.

AHPA’s petition includes requests for FDA to:

• • Clarify that a dietary ingredient manufacturer or supplier cannot be made subject to the final rule based on how its customers use its ingredients;
• • Remove a potential loophole that would allow companies that package products made by someone else to avoid some parts of the rules to verify product specifications are met;
• • Add definitions for the terms "manufacturing," "packaging," "labeling," and "holding;"
• • Allow master manufacturing records to include a range of batch sizes, rather than be limited to a specific batch size;
• • 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;
• • 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; and
• • 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," said Michael McGuffin, AHPA’s president."

Source: American Herbal Products Association, www.ahpa.org

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