Agency Response Letter GRAS Notice No. GRN 000016
CFSAN/Office of Premarket Approval
June 10, 1999
James T. Heimbach, Ph.D.
Environ International Corporation
4350 North Fairfax Drive, Suite 3000
Arlington, VA 22203
Re: GRAS Notice No. GRN 000016
Dear Dr. Heimbach:
The Food and Drug Administration (FDA) is responding to your letter dated March 5, 1999, concerning the notice 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 BASF Corporation that menhaden oil is GRAS, through scientific procedures, for use as a source of fat or for its nutritional properties in a variety of food categories at maximum levels of use, ranging from 0.5% to 12% by weight. FDA received your notice on March 11, 1999, and designated it as GRAS Notice No. GRN 000016.
Your June 8, 1999, letter states that BASF Corporation requests the withdrawal of GRN 000016 from consideration in accordance with proposed 21 CFR 170.36. Given your letter, FDA ceased to evaluate GRAS Notice No. GRN 000016, effective June 8, 1999, the date on which we received a fax copy of your letter.
In accordance with proposed 21 CFR 170.36(f), we have placed a copy of this letter, as well as a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1), in a file that is available for public review and copying in the public reading room of the agency's Freedom of Information Staff. A copy of this letter is also available for public review 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