Trade groups campaign for further changes to GMPs
changes to the FDA's proposed current good manufacturing practices
(cGMP), which they say would make it a more 'reasonable' assessment
of product quality.
The most important of the proposed changes were in the area of production and process controls. The submission from the American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the National Nutritional Foods Association (NNFA) described processes whereby product quality can be ensured by establishing appropriate specifications and by emphasizing control of raw materials and manufacturing processes, rather than accepting FDA's proposal to test quality at the end point, or finished product.
Proposals for the cGMPs were published last March and prompted numerous concerns in the industry. Trade associations individually submitted extensive comments last year addressing the proposed regulation but the new submission on January 30 is the result of cooperation by the three groups.
They all believe the rule should apply to both dietary ingredients and to dietary supplements, as FDA had proposed, provided that the final rule itself is modified to offer a more realistic framework for the entire industry.
They suggest written procedures for numerous manufacturing practices, consistent with the same suggestions made by the industry groups in a proposal submitted to FDA in 1995.
They have also requested that a statement of product shelf life should appear on product labels.
Michael McGuffin, AHPA's president, said: "Our three organizations were able to sort out all of our differences and arrive at a consensus position that provides an excellent model for appropriate cGMP for dietary supplements, by shifting from the agency's emphasis on exhaustive and unnecessary finished product testing to more appropriate attention to ensuring the quality of the raw materials and processes used in manufacturing."
"We believe that this document will assist the agency in its preparation of a rigorous but reasonable final rule," added Annette Dickinson, president of CRN.
The recommendations re-addressed many details that were identified in the proposed rule and in the original comments but they focus on issues that were either absent in FDA's proposed rule or in sharp contrast to industry needs.
The document is available on the AHPA website.
