Agency Response Letter GRAS Notice No. GRN 000150
CFSAN/Office of Food Additive Safety
October 4, 2004
Brent D. Rogers
P.O. Box 9300, MS 110
Minneapolis, MN 55440-9300
Re: GRAS Notice No. GRN 000150
Dear Mr. Rogers:
The Food and Drug Administration (FDA) is responding to the notice, dated April 6, 2004, that you submitted on behalf of Cargill Incorporated (Cargill) 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 April 9, 2004 and designated it as GRAS Notice No. GRN 000150.
The subject of the notice is glucosamine hydrochloride. The notice informs FDA of the view of Cargill that glucosamine hydrochloride is GRAS, through scientific procedures, for use in select beverages as defined in 21 CFR 170.3(n)(3), (7), (16), (31), (36) at a maximum level of 0.75 grams per serving.
In a letter dated September 9, 2004, you asked that FDA cease to evaluate Cargill's notice in light of process related changes in the manufacture of glucosamine, with the understanding that Cargill may, in the future, submit another GRAS notification or make another appropriate submission for glucosamine. Given your request, we ceased to evaluate GRN No. GRN 000150 effective September 9, the date we received 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 homepage of the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition