AHPA prepares cGMP comments
report summarizing input from recent meetings with the industry on
the FDA proposals for cGMPs, which will be sent to the agency to
demonstrate industry views.
The American Herbal Products Association (AHPA) has prepared a report summarizing input from recent meetings with the industry on the FDA proposals for cGMPs.
The document, which can be accessed on the AHPA website, highlights the problem areas with the proposed rules on current Good Manufacturing Practices. The FDA is accepting comments on the proposed rule on August 11, 2003.
AHPA president Michael McGuffin said: "I have heard several clear messages from the industry, which clearly support prompt implementation of cGMP for supplement products that will meaningfully address manufacturing issues, but who see real problems with FDA's proposal and especially with that agency's erroneous assumptions about this trade. The input that we have now received from AHPA's members and others has been essential to the initial preparation of our comments."
As part of an education effort, AHPA held meetings in Los Angeles, Portland, San Francisco, Salt Lake City and New Brunswick, NJ between May 22 and June 12, 2003, attended by around 65 companies (including 50 AHPA members, about 25 per cent of the entire AHPA membership).
The meetings involved discussion of the impact of the rule on various industry segments (e.g. raw material processors; finished product manufacturers; marketers), an in-depth review of the proposed rule (from an AHPA prepared worksheet) and a brief review of FDA's 1999 survey of the dietary supplement industry. This survey informed a Survey of Manufacturing Practices in the Dietary Supplement Industry, published by FDA in May 2000, claims the AHPA. Much of the recommendations that FDA has made in the proposed cGMP rule are based on response they received at that time, but this information is now out of date.
"The information that has served to support FDA's proposal is dated, at best," said McGuffin. "AHPA and its members should all have an interest in correcting the record by submitting contemporary information that can set the record straight."
At the regional meetings manufacturers were urged to complete and return this survey to AHPA.
