The American Herbal Products Association (AHPA) filed comments with the FDA yesterday suggesting that it may have hugely overestimated the economic benefits to the industry of the proposed GMPs.
Proposals for good manufacturing practice (cGMP) for dietary supplements were published by FDA on March 13, 2003. Several industry associations have submitted comments to the body requesting modifications.
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.
"AHPA continues to support the implementation of cGMP specific to dietary supplements," said Michael McGuffin, AHPA president, but added: "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 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 association analysed the benefits based on fewer product recalls, fewer illnesses associated with product recalls and fewer consumer search time. It suggests that FDA estimates may have overstated the reduction in illnesses, exaggerating unreported illnesses in sample cases. It has also assumed that illnesses will be reduced 100 per cent by the new rules, an unlikely event given current practice in the food and drug industry, suggests AHPA.
Further detail on AHPA's comments can be found on the website.