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U.S. Department of Health and Human Services

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Agency Response Letter GRAS Notice No. GRN 000019

CFSAN/Office of Premarket Approval

September 30, 1999

Mr. James Hyde
Albion Laboratories, Inc.
101 North Main
Clearfield, UT 84015-2243

Re: GRAS Notice No. GRN 000019

Dear Mr. Hyde:

The Food and Drug Administration (FDA) is responding to the notice, dated April 20, 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)). FDA received the notice on April 22, 1999 and designated it as GRAS Notice No. GRN 000019.

The subject of the notice is ferrous bisglycinate chelate. The notice informs FDA of the view of Albion Laboratories, Inc. (Albion) that ferrous bisglycinate chelate is GRAS, through scientific procedures, for use as a source of dietary iron for food enrichment and fortification purposes.

The notice describes (1) Albion's patented process for the synthesis of ferrous bisglycinate chelate; (2) subchronic toxicity studies in rats, which have been accepted for publication in a peer-reviewed journal; (3) unpublished acute oral toxicity studies in rats; and (4) references to published studies on the bioavailability and efficacy of ferrous bisglycinate chelate in humans. In telephone conversations with representatives of the Office of Premarket Approval, you clarified that dietary exposure to ferrous bisglycinate chelate would be consistent with existing iron supplementation guidelines, which provide for an intake of 18 mg of iron per person per day. The release and dietary exposure to glycine from ferrous bisglycinate chelate given this level of iron supplementation would be approximately 50 mg per person per day.

Based on the information provided by Albion, as well as other information available to FDA, the agency has no questions at this time regarding the conclusion of Albion that ferrous bisglycinate chelate is GRAS under the proposed conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of ferrous bisglycinate chelate. As always, it is your continuing responsibility to ensure that food ingredients that you market 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 this letter, as well as a copy of the information in your notice that conforms to the information in proposed § 170.36(c)(1), is available for public review and copying on the Office of Premarket Approval's homepage on the World Wide Web.

Sincerely,
   
Alan M. Rulis, Ph.D.
Director
Office of Premarket Approval
Center for Food Safety and Applied Nutrition