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FDA Premarket Approval: Process of Approving Olestra as a Food Additive

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Report Type Reports and Testimonies
Report Date April 7, 1992
Report No. HRD-92-86
Subject
Summary:

For more than 20 years, Proctor & Gamble has been trying to obtain premarket approval by the Food and Drug Administration (FDA) for Olestra--a noncaloric fat substitute covered by four U.S. patents. The first patent expired in 1988, and others will expire in 1994. Legislation has been introduced in Congress to extend Olestra's existing patents for another 10 years, beginning on the date of FDA approval. Proctor & Gamble believes that patent term extensions are justified because it views Olestra as a novel food additive for which FDA had no established regulatory approval path. The company contends that approval was delayed because it had to help FDA pioneer new scientific and administrative procedures to review the substance. This report examines the circumstance relating to actions by FDA and Proctor & Gamble during the last 21 years.

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