Agency Additional Correspondence Letter GRAS Notice No. GRN 000118
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CFSAN/Office of Food Additive Safety
Ying-Pi Lin, Ph.D.
Sensus America, Inc.
Princeton Corporate Plaza
Deer Park Drive, Suite J
Monmouth Junction, NJ 08852
Re: GRAS Notice No. GRN 000118
Dear Dr. Lin:
The Food and Drug Administration (FDA) is responding to your supplement dated May 3, 2007, that you sent regarding additional uses for the subject of GRN 000118. Environ Corporation initially submitted GRN 000118, on behalf of Imperial Sensus, LLC (now Sensus America, Inc.), 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 November 7, 2002, filed it on November 14, 2002, and designated it as GRN 000118. The subject of the notice is inulin from the root of the chicory plant (Cichorium intybus). The notice informed FDA of the view of Imperial Sensus, LLC that inulin is GRAS, through scientific procedures, for use in food in general, including meat and poultry products, as a bulking agent. In a letter dated May 5, 2003, FDA informed Environ Corporation that the agency had no questions at that time regarding Imperial Sensus, LLC's conclusion that the subject of the notice is GRAS under the intended conditions of use.
In a letter dated May 3, 2007, Sensus America, Inc. informed FDA of their determination that the addition of inulin is GRAS for use in baby foods, excluding infant formula, at levels up to 1 gram per serving. Sensus America, Inc. based their determination on information submitted in the original GRAS Notice as well as exposure information that was submitted in the supplement. Sensus America, Inc. concludes that the use level of inulin at a maximum level of 1 gram per serving in baby foods would not significantly increase the exposure to inulin for infants and children age 6 months and older.
Based on the information provided by Imperial Sensus, LLC in GRN 000118, the supplement dated May 3, 2007, and other information available to FDA, the agency has no questions at this time regarding Sensus America, Inc.'s conclusion that inulin is GRAS under the intended conditions of use in baby foods. The agency has not, however, made its own determination regarding the GRAS status of the subject use of inulin. As always, it is the continuing responsibility of Sensus America, Inc. to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to the supplement you submitted regarding GRN 000118, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (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 http://www.cfsan.fda.gov/~lrd/foodadd.html).
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition