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NUTRASWEET WILL FILE GRAS PETITION FOR SIMPLESSE

Executive Summary

NUTRASWEET WILL FILE GRAS PETITION FOR SIMPLESSE fat substitute, NutraSweet Chairman Robert Shapiro told FDA Commissioner Young in a Jan. 29 letter. The letter, following a Jan. 28 meeting between Shapiro and Young, stated: "As a result of yesterday's meeting, we will in the near future be filing a petition to affirm the GRAS (generally recognized as safe) status of the products made with Simplesse. We are confident that the data will support a conclusion of GRAS status." In developing Simplesse, Shaprio continued, "it has always been our intention to provide the Food and Drug Administration with all the information necessary to demonstrate the GRAS . . . status of the products that would be marketed." Shapiro met with the commissioner at Young's request, to discuss FDA's position that Simplesse requires FDA review despite the company's public assertion that no premarket clearance is necessary. At the meeting, Young explained that the company had two regulatory pathways available: petitioning for affirmation of GRAS status or submission of a food additive petition. NutraSweet is describing Simplesse as a natural product derived from egg whites and milk, two GRAS ingredients. Procter & Gamble filed a food additive petition for its synthetic fat substitute, Olestra, last June. Young requested the meeting, in a Jan. 27 letter, to discuss NutraSweet's failure to use "long-standing" FDA procedures in establishing the safety of Simplesse. "NutraSweet may be correct that the product is safe for food use," Young's letter said, "but the company has failed to use, and the press materials imply that it does not intend to use, long-established and orderly FDA procedures for determining whether a food ingredient is safe in a manner that assures agency involvement and appropriate public participation." NutraSweet's Jan. 27 press conference for Simplesse generated "major" media coverage, "of obvious interest to consumers and public health and nutrition communities," without prior substantive consultation with FDA, Young asserted. The FDA commissioner added that NutraSweet's contacting FDA a week before the press conference was too little, too late. NutraSweet estimates that the first products containing Simplesse would be in the market in 12 to 18 months. Both Simplesse and Olestra are said to be low in calories and cholesterol. Simplesse is designed for use in products such as ice cream, butter and mayonaise. Olestra is to be used in baking.
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