The American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN), and the National Nutritional Foods Association (NNFA) on January 30th submitted to the Food and Drug Administration (FDA) a “joint industry submission” to recommend specific language that would resolve the major concerns that have been identified by each of these organizations and their members about FDA’s proposed rule on current good manufacturing practice (cGMP) for dietary supplements, as published last March.
Each of these associations submitted extensive comments in August 2003 to address specific topics that they had identified separately. Those comments expressed similar but not identical views regarding key issues raised by the proposal. Immediately following the filing of these original comments, the three groups decided to work to see if they could identify and resolve any disparities between their separate comments and accompanying suggestions for modifications to the proposed rule.
“This has been a very fruitful and constructive experience,” stated Michael McGuffin, AHPA’s president. “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. David Seckman, NNFA’s Executive Director and CEO noted, “The modifications we are now suggesting are not extensive and most of FDA’s proposed rule would remain unchanged if our suggestions are adopted.”
This joint submission re-addressed many details that were identified in the proposed rule and in the original comments. The primary emphases, however, were on a few points that were either absent in FDA’s proposed rule or where the industry groups identified important disagreements with the agency’s approach or had differed with each other in their comments. Specifically:
- The joint industry submission expressed agreement that 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 provides a strong but realistic framework for the entire industry;
- The organizations have now all agreed that a statement of product shelf life should appear on product labels;
- Written procedures were suggested in the joint submission for numerous manufacturing practices, consistent with the same suggestions made by the industry groups in a proposal submitted to FDA in 1995;
- The most significant modifications suggested were in the area of production and process controls and the joint submission 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, that is, in the finished product.
The document that was submitted to FDA can be read or downloaded at http://www.ahpa.org/JointcGMPSubmission.pdf.