U. S. Food and Drug Administration
Center for Food Safety and Applied Nutrition
Office of Food Additive Safety
February 24, 2003

Mark W. Empie, Ph.D.
Vice President
Regulatory and Scientific Affairs
Archer Daniels Midland Company
1001 N. Brush College Rd.
Decatur, IL 62521

Re: GRAS Notice No.000115

Dear Dr. Empie:

The Food and Drug Administration (FDA) is responding to the notice, dated August 19, 2002, that you submitted on behalf of Archer Daniels Midland - Kao LLC (ADM-Kao) 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); the GRAS proposal). FDA received the notice on August 21, 2002, filed it on September 5, 2002, and designated it as GRAS Notice No. GRN 000115.

The subject of the notice is diacylglycerol oil. The notice informs FDA of the view of ADM-Kao that diacylglycerol oil is GRAS, through scientific procedures, for use as a substitute for vegetable oils in bakery products, salad dressings, mayonnaise, pizza, breakfast/snack/power bars, soups and gravies, meal replacements, and frozen dinner entrees.

In GRN 000115, ADM-Kao incorporates by reference certain data and information from a previous GRAS notice (GRN 000056) for the use of diacylglycerol oil as a substitute for vegetable oils in cooking oil and in the commercial formulation of spread. GRN 000056 was submitted by the law firm of Morgan, Lewis & Bockius, LLP on behalf of Kao Corporation. In a letter dated October 28, 2002, Kao Corporation informed FDA that it had formed a joint venture company (i.e., ADM-Kao) with Archer Daniels Midland Company, and that it had transferred the responsibility for GRN 000056 to this joint venture company. Thus, in FDA's view, Kao Corporation has transferred, and ADM-Kao has accepted, the responsibility for the previous determination by Kao Corporation that diacylglycerol oil is GRAS for use as a substitute for vegetable oils in cooking oil and in the commercial formulation of spread.

As FDA discussed in its response to GRN 000056, that notice described generally available information about the identity, characteristic properties, and functionality of diacylglycerol oil. Diacylglycerol oil is composed of greater than 80 percent diacylglycerol as a mixture of 1,3-diglyceride and 1,2-diglyceride at a ratio of 7:3. The main fatty acid constituents of diacylglycerol oil are oleic acid (C18:1), linoleic acid (C18:2) and linolenic acid (C18:3). The method of manufacture of diacylglycerol oil (which includes the enzyme-catalyzed esterification of fatty acids derived from natural edible plant oils and either monoacylglycerol or glycerol) and the specifications for food-grade diacylglycerol oil are the same as presented in GRN 000056. In GRN 000056 and GRN 000115, Kao and ADM-Kao describe studies conducted with diacylglycerol oil, including published absorption and metabolism studies; unpublished acute, subchronic and chronic toxicity studies; an unpublished mutagenicity study; and published and unpublished clinical studies designed to study the effects of diacylglycerol oil on circulating lipid levels.

In GRN 000115, ADM-Kao includes an estimate of the daily intake of diacylglycerol from the two food categories that were the subject of GRN 000056 (i.e., current uses) and from the total ten food categories (i.e., current plus expanded uses, which are the subject of GRN 000115). ADM-Kao estimates that the expected consumption of diacylglycerol oil from its current use in edible oil and spread range from approximately 0.2 to 0.4 grams/kilogram body weight/day (g/kg bw/d) at the 90th percentile. ADM-Kao also estimates that the expected consumption of diacylglycerol oil from its current and expanded uses would range from approximately 0.3 to 0.5 g/kg bw/d at the 90th percentile. ADM-Kao notes that diacylglycerol oil is not intended for use in repetitive, institutional frying applications.

GRN 000115 includes the findings of a panel of individuals (ADM-Kao's GRAS panel) who evaluated the data and information that are the basis for ADM-Kao's GRAS determination. ADM-Kao considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. ADM-Kao's GRAS panel concluded that diacylglycerol oil is GRAS, through scientific procedures, when used for home cooking oil, commercial formulation of spread, salad dressings, mayonnaise, pizza, soups, gravies, meal replacements, frozen dinner entrees, bakery products, and breakfast/snack/power bars, provided that diacylglycerol oil meets food grade specifications and is produced in accordance with current good manufacturing practices.

Issues that are the purview of the Office of Nutritional Products, Labeling, and Dietary Supplements

In its response to GRN 000056, FDA noted that an ingredient that is lawfully added to food products may be used in a standardized food only if it is permitted by the applicable standard of identity. FDA also noted that "margarine" is a standardized food governed by regulations in Title 21 of the Code of Federal Regulations (21 CFR) Part 166 and that diacylglycerol may not lawfully be used in margarine. In GRN 000115, ADM-Kao states its intention to use diacylglycerol oil in several food categories, including foods governed by specific standards of identity. Such standardized foods include certain bakery products (21 CFR Parts 136 and 152) and food dressings (21 CFR Part 169).⁽¹⁾ If ADM-Kao has any questions about the use of diacylglycerol oil in standardized foods that would be marketed in the United States, ADM-Kao should contact the staff in the Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS), Division of Food Labeling, Standards, and Compliance, HFS-820, 5100 Paint Branch Parkway, College Park, MD 20740. ADM-Kao can reach this division by telephone at (301) 436-2371.

As also noted in its response to GRN 000056, under section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA), a food is misbranded if its labeling is false or misleading in any particular, and under section 403(r) of the FFDCA a food is misbranded if its labeling bears a claim characterizing the relationship of a nutrient or other food component to a disease or health-related condition unless the claim is made in accordance with a regulation authorizing such a claim. Similarly GRN 000115 raises a potential labeling issue (i.e., purported physiological effects of diacylglycerol oil that ADM-Kao views as "beneficial") under these labeling provisions of the FFDCA. If products that contain diacylglycerol oil bear any claims about such benefits on the label or in labeling, such claims are the purview of ONPLDS in the Center for Food Safety and Applied Nutrition. As was the case with GRN 000056, the Office of Food Additive Safety neither consulted with ONPLDS on this labeling issue nor evaluated the information in the notice to determine whether it would support any claims made about diacylglycerol oil on the label or in labeling.

Use in meat and poultry products

During its evaluation of GRN 000115, FDA consulted with the Labeling and Consumer Protection Staff of the Food Safety and Inspection Service (FSIS) of the United States Department of Agriculture (USDA). Under the Federal Meat Inspection Act and the Poultry Products Inspection Act, FSIS is responsible for determining the efficacy and suitability of food ingredients in meat and poultry products as well as prescribing safe conditions of use. Suitability relates to the effectiveness of the ingredient in performing the intended purpose of use and the assurance that the conditions of use will not result in an adulterated product, or one that misleads consumers.

FSIS would not object to the use of diacylglycerol oil as a replacement for vegetable oils in the production of meat and poultry products. If, however, ADM-Kao has any questions about the use of diacylglycerol oil in such products, ADM-Kao should direct such an inquiry to Dr. Robert Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program Development and Evaluation, Food Safety and Inspection Service, 1400 Independence Ave., S.W., Suite 602, Annex, Washington, DC 20250-3700. The telephone number for his office is (202) 205-0279 and the telefax number is (202) 205-3625.

Conclusions

Based on the information provided by ADM-Kao, as well as other information available to FDA, the agency has no questions at this time regarding ADM-Kao's conclusion that diacylglycerol oil 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 diacylglycerol oil. As always, it is the continuing responsibility of ADM-Kao 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 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).

cc: Dr. Robert Post, Director
Labeling and Consumer Protection Staff
Office of Policy, Program Development and Evaluation
Food Safety and Inspection Service
1400 Independence Ave., SW, Suite 602, Annex
Washington, DC 20250-3700

⁽¹⁾Food dressings would include salad dressings and mayonnaise.