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Agency Response Letter GRAS Notice No. GRN 000107

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See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory

CFSAN/Office of Food Additive Safety
October 17, 2002

Michael. H. Auerbach, Ph.D.
Director, Scientific Services, Regulatory Affairs
Danisco Cultor USA, Inc.
440 Saw Mill River Road
Ardsley, NY 10502-2606

Re: GRAS Notice No. GRN 000107

Dear Dr. Auerbach:

The Food and Drug Administration (FDA) is responding to the notice, dated April 29, 2002, that you submitted in accordance with the agency's proposed regulation, proposed 21 CFR 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS)). FDA received the notice on April 30, 2002, filed it on May 1, 2002, and designated it as GRAS Notice No. GRN 000107.

The subject of the notice is polydextrose. The notice informs FDA of the view of Danisco Cultor USA, Inc. (Danisco) that polydextrose is GRAS, through scientific procedures, for use in non-sweet baked goods, breading and batter coatings, flavor bits on crackers, snack chips, ready-to-eat breakfast cereals, surimi (minced fish and meat), ready-to-drink nutritional beverages, non-carbonated beverages, and dry beverage mixes for multiple technical effects at varying levels.

In a letter dated October 17, 2002, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective October 17, 2002, the date that we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter, as well as a copy of the information in your notice that conforms to the information in proposed 21 CFR 170.36(c)(1), is available for public review and copying on the homepage of the Office of Food Additive Safety (on the Internet at

Linda S. Kahl, Ph.D.
Division of Biotech and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

The location of this letter on FDA's website as described in the text is out of date. To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the "Food" topic on the FDA home page at to the "Food Ingredients and Packaging" section to the "Generally Recognized as Safe (GRAS)" page where the GRAS Inventory is listed.

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