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Agency Response Letter GRAS Notice No. GRN 000655

Recently Published GRAS Notices and FDA Letters

See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

October 7, 2016

Donald Schmitt, MPH
Senior Managing Scientist
ToxStrategies, Inc.
739 Thornapple Drive
Naperville, IL 60540

Re: GRAS Notice No. GRN 000655

Dear Mr. Schmitt:

The Food and Drug Administration (FDA) is responding to the notice, dated June 3, 2016, that you submitted on behalf of J.M. Smucker Co. (Smucker) 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 June 7, 2016, filed it on June 28, 2016, and designated it as GRAS Notice No. GRN 000655.

The subject of the notice is rice bran wax. The notice informs FDA of the view of Smucker that rice bran wax is GRAS, through scientific procedures, for use as a texturizing agent in peanut butter at a level of 3-4%.

In an email dated September 20, 2016, you asked that FDA cease to evaluate your notice. You mentioned that Smucker is in the process of addressing estimated daily intake and safety data issues and intends to submit a revised GRAS notice in the near future. Given your request, we ceased to evaluate your GRAS notice, effective September 20, 2016, the date that we received your email.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000655, 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 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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