January 30, 2001

Mr. Richard F. Mann
Keller and Heckman, LLP
1001 G Street, N.W.
Suite 500 West
Washington, DC 20001

Re: GRAS Notice No. GRN 000037

Dear Mr. Mann:

The Food and Drug Administration (FDA) is responding to additional correspondence that you sent regarding GRAS Notice No. GRN 000037. In GRN 000037, which you submitted on behalf of the American Dairy Products Institute (ADPI), you requested that FDA convert the filed GRAS affirmation petition GRP 1G0371 to a GRAS notice 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 conversion request informed FDA of the view of ADPI that whey protein isolate and dairy product solids are GRAS for use in food.

In a letter dated April 21, 2000, FDA informed you that we had no questions at that time about ADPI's conclusion that whey protein isolate and dairy product solids are GRAS under the intended conditions of use. In that letter, we cited "whey mineral concentrate" as an alternate name for dairy product solids. We included this alternate name because ADPI, in its original submission of GRP 1G0371, characterized "whey mineral concentrate" as another term for "dairy product solids."

In its original submission of GRP 1G0371, ADPI requested that FDA affirm as GRAS three modified whey products: (1) whey protein isolate; (2) dairy product solids; and (3) lactose product. In a subsequent amendment, ADPI narrowed the scope of GRP 1G0371 to request that FDA affirm as GRAS two of these three modified whey products, i.e.,whey protein isolate and dairy product solids. According to ADPI, the third modified whey product covered by the initial petition (i.e., lactose product) would be encompassed within the definition of dairy product solids.

In a letter dated January 19, 2001, ADPI explained that at the time it submitted GRP 1G0371, dairy product solids was defined as a permeate product with variable levels of protein, ash, lactose, and solids, and that as such, it was similar to "whey mineral concentrate." Subsequent to the initial submission of GRP 1G0371, ADPI, at FDA's request, provided specifications for dairy product solids; these specifications included a minimum lactose content of 59 percent. Given these specifications, "whey mineral concentrate" and "dairy product solids" no longer necessarily describe the same food ingredient. For this reason, ADPI believes that the reference to "whey mineral concentrate" in FDA's April 21, 2000 letter may cause some confusion and perhaps should be eliminated.

As you are aware, Glanbia Ingredients, Inc. (Glanbia) has submitted a GRAS Notice (GRN No. 000052) for whey mineral concentrate. In GRN 000052, Glanbia specifically describes differences between "whey mineral concentrate" and "dairy product solids." For example, whey mineral concentrate typically contains 9 percent lactose, and dairy product solids contains at least 59 percent lactose. Given Glanbia's notice, we agree that "whey mineral concentrate" is not an alternative name for "dairy product solids." We believe that this additional correspondence is sufficient to clarify this matter, particularly in light of the fact that "dairy product solids" and "whey mineral concentrate" are listed separately in the Inventory of GRAS Notices.

Consistent with our April 21 letter, based on the information provided by ADPI, as well as the information in GRP 1G0371 and other information available to FDA, the agency has no questions at this time regarding ADPI's conclusion that whey protein isolate and dairy product solids are GRAS under the intended conditions of use.

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 Internet (at http://www.cfsan.fda.gov/~lrd/foodadd.html).

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