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Industry Submits GMP Comments


Government

Industry Submits GMP Comments

WASHINGTONIn early August, several industry organizations submitted comments concerning the Food and Drug Administrations (FDA) proposed good manufacturing practices (GMPs). The American Herbal Products Association (AHPA), the Council for Responsible Nutrition (CRN) and the National Nutritional Foods Association (NNFA) were some of the organizations giving FDA their two cents worth.

AHPA submitted its comments in three parts: a detailed commentary that included suggestions for modifications, a redline edit that incorporated the changes into FDAs proposal, and a frank discussion of errors and misrepresentations that appeared in FDAs preamble of the proposed rule. Suggestions included FDA apply the same standard for qualifying personnel in the dietary supplement industry as in the food and drug industries; specifications for purity be mandated insofar as necessary to address public health issues and represented claims; and testing requirements that do not force manufacturers to test quality when analytical methods do not exist. Now that we are past the hurdle of providing thoughtful comments to FDAs proposal, industry must develop strategies for additional actions related to product quality and consumer perception of quality, said Michael McGuffin, AHPA president. (AHPAs comments can be found on its Web site at www.ahpa.org/03gmpfinal.pdf.)

CRN made four submissions to FDA during the comment period, which ended Aug. 11. In its comments, CRN proposed the rule apply only to finished product manufacturers, that it cover dietary supplements not dietary ingredients and that FDA explain the definition of manufacturer. CRN and its member companies support enhanced dietary supplement GMPs, but we do not believe they are essential as a prerequisite to FDA action against misbranded or adulterated products, and we do not believe they will reduce recalls to zero, as FDAs economic analysis predicts, concluded Annette Dickinson, Ph.D., CRN president. Because of the importance of issues such as these, we urge the agency to hold a public hearing or perhaps a series of public workshops on key aspects of the proposed rule, in order to help craft an appropriate and workable final rule. (CRNs comments can be found on its Web site at www.crnusa.org/leg_comments_FDA_081103.html.)

In a 120-page letter to FDA, NNFA reported the requirements for effective process control should be revisited. In addition, FDAs proposal excluded the use of written procedures and documentation for some key areas in an effort to reduce the economic burden of the proposal. Also, the testing approach should be more flexible and cost-efficient. The proposed rule would require analytical testing of every ingredient of every batch at the finished product stage if possible, NNFA (www.nnfa.org) wrote.

NNFA also recommended the final rule permit the use of verified certificates of analysis to confirm testing has been conducted and that ingredients meet the manufacturers specifications. Also, testing responsibilities along the supply chain should be clearly demarcated, according to NNFA, which recommended the final regulation make it clear that testing obligations fall primarily upon the raw material supplier and the manufacturer of the finished product, and that only one company in the chain has to perform the appropriate testing. NNFA also recommended GMPs apply to the entire industry, including raw material suppliers and foreign firms.

NNFA believes its recommendations are more economical than FDAs proposal, without compromising the goal of GMPs. NNFA also wrote FDAs assessment of the economic impact of the proposed rule grossly underestimated the cost to the industry. FDA officials stated during the course of the stakeholder meeting process that the rule would put approximately 250 companies out of business. Based on a survey we conducted of our members, NNFA believes this estimate should be much higher, NNFA wrote. Moreover, many multi-ingredient products will no longer be economical to manufacture and will disappear from retailers shelves. We estimate that prices of the products that remain on retail shelves will increase by approximately 35 to 50 percent.

TAGS: Regulatory
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