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[资源] 【分享】 Enhancing the Regulatory Decision-Making Approval【已搜索无重复】

Title: Enhancing the Regulatory Decision-Making Approval Process for Direct Food Ingredient Technologies: Workshop Summary (Compass Series)
Author: Food Forum, Institute of Medicine
Publisher: National Academy Press
Publication Date: 1999-04
Number Of Pages: 150

WORKSHOP SUMMARY
Opinions vary on the historical success of the U.S. Food and Drug Administration (FDA) in protecting the American public from harmful food ingredients. Industry and academic representatives credit the agency with prevention of public health emergencies associated with consumption of food substances. Consumer groups are reluctant to praise FDA, and are not convinced that the public has been adequately served by the food additive petition process. The cases of violet dye #1 and sulfites are cited as historical examples of once-approved ingredients that may have adversely affected the public's health.

In the absence of timely approval, industry is likely to rely more heavily on the statutory exception for Generally Recognized as Safe (GRAS) substances to facilitate the marketing of new ingredients. A recent FDA proposed rule (see section on "Extramural Reviews" in Appendix A), if finalized, would eliminate the FDA GRAS affirmation process and establish a FDA GRAS notification procedure in its place.

However, not all potential ingredients can detour food additive review. Reform of the formal food additive review process may significantly affect the willingness of manufacturers to invest substantial sums of money in the research and development of new technologies. Congressional intent in enacting the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic (FD&C) Act was to create a process that would encourage technological development, not hinder it. This statute may need updating to serve this purpose. At the same time, it must continue to protect the food supply for the consuming public.

Three major themes emerged during the workshop. First, communication is a key to enhancing the regulatory review process. Well-developed food additive petitions that include all of the necessary data can only serve to enhance scarce agency resources. However, the determination of the appropriate level of communication needs further exploration. What some may consider to be a consultative process may appear to be collaborative to others.

Second, solving complex food ingredient issues requires the involvement of many scientific disciplines that are often not available within the FDA staff. Often, outside experts residing in academia, professional scientific associations, and public interest groups may need to be involved in the evaluation process, but barriers, such as the Federal Advisory Committee Act and the confidential nature of the data submitted, limit the involvement of outside experts.

available online from here:

http://newton.nap.edu/catalog/9453.html#toc

[ Last edited by signal023 on 2008-5-15 at 20:38 ]

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