The American Herbal Products Association (AHPA), Silver Spring, MD, the Council for Responsible Nutrition (CRN), Washington, D.C., and the National Nutritional Foods Association (NNFA), Washington, D.C., recently submitted to 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 practices (cGMPs) for dietary supplements published last March. This joint submission re-addresses many details that were identified in the proposed rule and in the original comments. The primary emphasis, 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 establish 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 line with 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.