Agency Response Letter GRAS Notice No. GRN 000031
CFSAN/Office of Premarket Approval
January 12, 2000
Mr. Curtis W. Coleman
Safe Foods Corporation
1505 Rebsamen Park Road
Little Rock, AR 72202
Re: GRAS Notice No. GRN 000031
Dear Mr. Coleman:
The Food and Drug Administration (FDA) is responding to the notice, dated September 15, 1999, 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)). Your notice informed FDA of the view of Safe Foods Corporation that cetylpyridinium chloride (CPC) is GRAS, through scientific procedures, for use as an antimicrobial treatment in various types of raw and fully cooked food products that may include poultry, red meat, fish and shellfish, eggs, fruits, vegetables, cereal grains, nutmeats, and dairy products at a level not to exceed 1 percent in any food category. FDA received your notice on September 20, 1999 and designated it as GRAS Notice No. GRN 000031.
In your letter dated January 10, 2000, Safe Foods Corporation withdrew GRAS Notice No. 000031 from consideration under proposed 21 CFR 170.36. Given your letter, FDA ceased to evaluate GRAS Notice No. 000031, effective January 10, 2000, the date that we received a telefax copy of 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 Office of Premarket Approval's homepage on the World Wide Web.
Linda S. Kahl, Ph.D.
Regulatory Policy Branch (HFS-206)
Division of Product Policy
Office of Premarket Approval
Center for Food Safety and Applied Nutrition