January 30, 2001

Mr. Richard F. Mann
Keller & Heckman LLP
1001 G Street, N.W.
Suite 500 West
Washington, D.C. 20001

Re: GRAS Notice No. GRN 000052

Dear Mr. Mann:

The Food and Drug Administration (FDA) is responding to the notice, dated June 26, 2000, that you submitted on behalf of Glanbia Ingredients, Inc., 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 June 27, 2000 and designated it as GRAS Notice No. GRN 000052.

The subject of the notice is whey mineral concentrate. The notice informs FDA of the view of Glanbia Ingredients, Inc., that whey mineral concentrate is GRAS, through scientific procedures, for use as a source of calcium in fortified beverages, fortified foods, and enriched dairy products.

The notice provides information that whey mineral concentrate is produced by subjecting pasteurized fluid whey to a precipitation and membrane separation process, followed by purification and drying. The resulting concentrate is a free-flowing white powder that is soluble at acid pH. Whey mineral concentrate typically contains 79 percent total minerals (including 24 percent calcium; 41 percent phosphorus, as phosphate; and 9 percent organic mineral, as citrate), 9 percent lactose, and 5 percent protein. Glanbia provides specifications for whey mineral concentrate, including specifications for residue on ignition and for microorganisms such as Salmonella and Listeria, and a lead specification of 0.5 ppm.

Glanbia intends to use whey mineral concentrate as a source of calcium in fortified beverages, fortified foods (including nutrition bars, bakery products, sport beverages, and isotonic beverages), and enriched dairy products. Glanbia recommends the use of whey mineral concentrate at levels consistent with current calcium supplementation guidelines, such as those of the National Academy of Sciences (which recommends between 1,000 and 1,300 mg of calcium per day for adults, with a tolerable upper limit of 2,500 mg per day).

The notice describes the relationship between whey mineral concentrate and other whey products that FDA has affirmed as GRAS. These products include fluid whey (21 CFR 184.1979), reduced lactose whey (21 CFR 184.1979a), reduced minerals whey (21 CFR 184.1979b), and whey protein concentrate (21 CFR 184.1979c). The notice cites the preamble to the final rule affirming these whey products as GRAS. In that final rule, FDA stated that: "The agency does not intend to limit the processing methods that may be used. Furthermore, the agency has no objection to the use of newly developed physical separation techniques, if there are no new toxicants introduced as a result of these techniques, and if these techniques do not result in a concentration of natural toxicants in whey products. FDA believes that such results can be avoided by the use of good manufacturing practices and by the establishment of specifications for heavy metals (September 4, 1981; 46 FR 44434 at 44437)." In this final rule (44438), FDA also stated that "The agency believes that whey minerals concentrate and whey lactose concentrate are suitable subjects for food additive or GRAS affirmation petitions ..."

Based on the information provided by Glanbia, as well as other information available to FDA, the agency has no questions at this time regarding Glanbia's conclusion that whey mineral concentrate is GRAS under the intended conditions of use. The agency has not, however, made its own determination regarding the GRAS status of the subject use of whey mineral concentrate. As always, it is the continuing responsibility of Glanbia to ensure that food ingredients that the firm markets 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 the text of this letter, as well as a copy of the information in the 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 Internet (at http://www.cfsan.fda.gov/~lrd/foodadd.html).

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