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Agency Response Letter GRAS Notice No. GRN 000582

Recently Published GRAS Notices and FDA Letters

See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

December 4, 2015

J. Caroline English, Ph.D., DABT
NSF International
151 Stone Pine Ln
Menlo Park, CA 94025

Re: GRAS Notice No. GRN 000582

Dear Dr. English:

The Food and Drug Administration (FDA) is responding to the notice, dated May 19, 2015, that you submitted on behalf of Industrializadora Intergral del Agave SA de CV (IIDEA) 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); the GRAS proposal). FDA received the notice on May 21, 2015, filed it on June 30, 2015, and designated it as GRAS Notice No. GRN 000582.

The subject of the notice is inulin from Agave tequilana. The notice informs FDA of the view of IIDEA that inulin from Agave tequilana is GRAS, through scientific procedures, for use as a bulking agent and sweetener in foods (excluding meat and poultry products, infant formulas, and baby foods) and beverages at levels ranging from 2 to 8 grams per serving.

In a letter dated November 25, 2015, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective November 25, 2015, the date that we received your letter.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000582, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at http://www.fda.gov/grasnoticeinventory.


Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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