April 21, 2000

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 your letter, dated January 13, 2000, that you submitted on behalf of the American Dairy Products Institute (ADPI). Your letter requests 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)). FDA received this conversion request on January 14, 2000 and designated it as GRAS Notice No. GRN 000037.

Your conversion request relates to two direct human food ingredients: whey protein isolate and dairy product solids. Your conversion request informs FDA of the view of ADPI that whey protein isolate and dairy product solids are GRAS, through experience based on common use in food, for use in food. According to your conversion request, whey protein isolate would be used for nutritional purposes as a source of high quality protein in a wide variety of high-energy food and beverage products. Whey protein isolate would also be used for a variety of functional effects that are associated with proteins, e.g., as a gelation aid in yogurts and pudding, as a water binder in meat and sausage, as a foaming or whipping aid in toppings and fillings, and as an emulsifier in ice cream, margarine, and mayonnaise. According to your conversion request, dairy product solids would be used in a wide variety of foods, and in the production of alcohol and organic chemicals, galactose and glucose syrups, and sugar and corn syrup replacers.

In 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 an amendment dated January 10, 1995, 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.

On March 29, 2000, you discussed the statutory basis for ADPI's GRAS determination with Dr. Linda Kahl of this office. GRP 1G0371 makes clear that both whey protein isolate and dairy product solids are prepared by processes that were not common before 1958. Thus, although these ingredients had been consumed as components of food prior to January 1, 1958, they had not been isolated and consumed as such prior to that date. Given these facts, you agreed that it would be appropriate for the agency to evaluate ADPI's conversion request under scientific procedures. In a letter dated April 4, 2000, you confirmed this agreement.

Whey protein isolate

Whey protein isolate is related to whey protein concentrate, which is affirmed as GRAS (21 CFR 184.1979c). Under 21 CFR 184.1979c, whey protein concentrate is produced from whey using physical separation techniques that remove sufficient non-protein constituents from whey so that the finished dry product contains not less than 25 per cent protein. In GRP 1G0371, ADPI cites the final rule that affirmed the GRAS status of whey protein concentrate: "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 44435 at 44437)

According to GRP 1G0371, whey protein isolate is produced from whey using physical separation techniques that remove sufficient non-protein constituents from whey so that the finished dry product contains not less than 90 per cent protein. As with whey protein concentrate, whey protein isolate is either derived from whey that has been pasteurized, or is itself subjected to pasteurization techniques (or their equivalent) before use in food. GRP 1G0371 includes specifications for whey protein isolate, including a specification that the lead content would not exceed 0.5 parts per million.

Dairy product solids

Dairy product solids (which is also called "whey mineral concentrate") is related to lactose, which is a standardized product (21 CFR 168.122) that is normally obtained from whey and contains at least 98 per cent lactose. In GRP 1G0371, ADPI notes that a substantial market exists for food ingredients that are similar to lactose but do not have a high enough lactose content to meet the current standard. Dairy product solids is also related to whey, which is affirmed as GRAS (21 CFR 184.1979). In GRP 1G0371, ADPI cites the final rule that affirmed the GRAS status of whey protein concentrate, in which FDA noted that the product known as whey minerals concentrate would be a suitable subject for a GRAS affirmation petition (46 FR 44438).

According to GRP 1G0371, dairy product solids is a modified dairy product produced from milk or whey through physical separation techniques such as precipitation, filtration, or dialysis. The lactose content of dairy product solids is at least 59 per cent. The levels of the major components of dairy product solids (i.e., lactose, protein, ash, moisture, and fat) vary depending on the base dairy product (i.e., milk or whey). As with whey protein isolate, dairy product solids is either derived from milk or whey that has been pasteurized, or is itself subjected to pasteurization techniques (or their equivalent) before use in food. GRP 1G0371 includes specifications for dairy product solids, including a specification that the lead content would not exceed 0.5 parts per million.

FDA's evaluation of the data and information in GRP 1G0371

FDA has evaluated the information in GRP 1G0371, as well as other data and information that are available to the agency.

FDA estimates that the current consumption of whey products on a per capita basis is approximately 3.8 grams per person per day (g/p/d) and that the incremental per capita exposure to whey products from the consumption of whey protein isolate and dairy product solids would be approximately 0.2 g/p/d, an increase of 5 percent.

FDA estimates that approximately 99 percent of the U.S. population consumes lactose-containing products.⁽¹⁾ In addition, FDA estimates that the current mean consumption of lactose is approximately 16 grams per person per day (g/p/d) and that the current 90th percentile consumption of lactose is approximately 33 g/p/d. FDA also estimates that the incremental consumption of lactose from the consumption of whey protein isolate and dairy product solids would be less than 0.1 g/p/d, an increase of approximately 0.3 percent.

Conclusions

Based on the information provided by ADPI in GRP 1G0371, as well as 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. The agency has not, however, made its own determination regarding the GRAS status of the subject use of whey protein isolate and dairy product solids. As always, it is the continuing responsibility of ADPI to ensure that food ingredients that the firm markets are safe, and are otherwise in compliance with all applicable legal and regulatory requirements.

FDA consulted with the Labeling and Additives Policy Division (LAPD) of the Food Safety and Inspection Service (FSIS), United States Department of Agriculture, regarding the use of whey protein isolate and dairy product solids in meat or poultry products. Because GRP 1G0371 mentions the use of whey protein isolate as a water binder in meat and sausage, LAPD specifically commented on this use. For your information, binders are regulated under the statutes that FSIS implements based on efficacy of use. FSIS generally has viewed binders and extenders that are used at levels greater than 3.5 percent of the product as recharacterizing products. Based on the information in GRP 1G0371, FSIS has concluded that whey protein isolate and dairy product solids, when used at a level not to exceed 3.5 percent of the product, would be acceptable as binders in various non-standardized meat or poultry products. Currently, however, there are no allowances for the use of whey protein isolate or dairy product solids in standardized meat or poultry products. LAPD requested that we advise you to seek regulatory guidance regarding whether the use of whey protein isolate or dairy product solids requires rulemaking under the statutes that FSIS implements. You should direct your inquiry to Dr. Robert Post, Director, LAPD, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, 300 12th Street, SW, Room 602, Washington, DC 20250-3700. The telephone number for LAPD is (202) 205-0279 and the FAX number is (202) 205-3625.

In accordance with the interim policy discussed in the GRAS proposal (62 FR 18938 at 18954), FDA has not committed any resources to review of GRP 1G0371 since January 14, 2000, the date that we received your conversion request. At this time, we request that you formally withdraw GRP 1G0371.

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 World Wide Web.

⁽¹⁾The standard of identity for lactose in 21 CFR 168.122 covers the use of lactose as a sweetener or table sirup. Lactose is also consumed in foods such as infant foods, dairy products, prepared dry mixes, bakery products, special dietary foods, and confections.

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