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Proposed GMPs Seen as Costlier Than FDA Estimates
Silver Springs MD, 10 September 2003

The American Herbal Products Association (AHPA) filed comments yesterday related to the FDA's estimates of the costs and benefits associated with the agency's proposed good manufacturing practice (cGMP) for dietary supplements, as published by FDA on 13 March 2003.

Additional comments from AHPA filed per 30-day extension

AHPA had submitted comments to the proposed rule last month to address most of the issues that AHPA member companies had identified as important. AHPA had also requested and obtained an additional 30 days to file comments on the economic factors that were discussed in yesterday's comments.

The document submitted yesterday expressed concerns that the agency may have, in analyzing the economic impact of the proposed rule, overstated the economic benefits and understated the costs.

While FDA stated that the annual benefit of the proposed cGMP will be $218 million, AHPA suggests that the actual benefit may be only $21 million, or even less. Similarly, FDA calculated the annual industry cost to be $86 million, while AHPA's evaluation estimates the actual cost to be at least $700 million if the agency fails to consider appropriate modifications to the rule.

Editor's Note: If AHPA's estimates are correct, the cost would be 814% higher than FDA projections and the benefits only 10% of FDA projections.

"AHPA continues to support the implementation of cGMP specific to dietary supplements," stated Michael McGuffin, AHPA's President. "The concerns we have expressed about the excessive costs of FDA's proposal, however, must be addressed in the rulemaking process. AHPA encourages the agency to seriously consider the revisions we suggested in our earlier comments, to establish a more affordable, but equally effective rule."

AHPA's website has comments on GMP economic impact in PDF format (www.ahpa.org/03Sept09CommentscGMPEconomicsFinal.pdf).


American Herbal Products Association (AHPA).end-of-story


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