Agency Response Letter
GRAS Notice No. GRN 000217

George A. Burdock, Ph.D.
Burdock Group
2001 9^th Avenue
Vero Beach, FL 32960

Re: GRAS Notice No. GRN 000217

Dear Dr. Burdock:

The Food and Drug Administration (FDA) is responding to the notice, dated December 14, 2006, that you submitted on behalf of Nisshin OilliO Group USA, Inc. (Nisshin OilliO) 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 December 18, 2006, filed it on December 21, 2006, and designated it as GRAS Notice No. GRN 000217.

The subject of the notice is tailored triglycerides containing approximately 12 percent medium-chain fatty acids (tailored triglycerides (12 percent MCFAs) ingredient).⁽¹⁾ The notice informs FDA of the view of Nisshin OilliO that the tailored triglycerides (12 percent MCFAs) ingredient is GRAS, through scientific procedures, for use as an oil in home cooking, salad dressings, vegetable-oil spreads, and frozen dinners (including meat and poultry), providing a maximum daily intake of 31 grams per person per day (g/p/d).

21 CFR 101.4 states that all ingredients must be declared by their common or usual name. In addition, 21 CFR 102.5 outlines general principles to use when establishing common or usual names for nonstandardized foods. Our use of "tailored triglycerides (12 percent MCFAs) ingredient" in this letter should not be considered an endorsement or recommendation of that term as an appropriate common or usual name for the purpose of declaring the substance in the ingredient statement of foods that contain that ingredient. Issues associated with labeling and the appropriate common or usual name of a food are the responsibility of the Center for Food Safety and Applied Nutrition's Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS).

As part of its notice, Nisshin OilliO includes the report of a panel of individuals (Nisshin OilliO's GRAS panel) who evaluated the data and information that are the basis for Nisshin OilliO's GRAS determination. Nisshin OilliO considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Nisshin OilliO's GRAS panel evaluated estimates of dietary exposure, method of manufacture, and product specifications as well as published and unpublished studies regarding the safety of the ingredient and related oils. Based on this review, Nisshin OilliO's GRAS panel concluded that the tailored triglycerides (12 percent MCFAs) ingredient, meeting established food-grade specifications, is GRAS under the conditions of its intended use as an oil in home cooking, salad dressings, vegetable-oil spreads, and frozen dinners (including meat and poultry).

Tailored triglycerides (12 percent MCFAs) ingredient is made from edible vegetable oils and medium-chain triglycerides (MCTs). Edible vegetable oils (predominantly long-chain triglycerides (LCTs)) include canola, soybean, cottonseed, sunflower-seed, peanut, olive, corn, safflower-seed, rice bran, and sesame-seed oils. Manufacturing of these oils includes extraction, degumming, deacidification (treatment with alkali), bleaching, and deodorizing processes. MCTs are produced from coconut or palm-kernel oil. Briefly, free fatty acids are obtained from coconut or palm-kernel oil, either by saponification or by hydrolysis with high pressure steam. The fatty acids from the coconut and palm-kernel oil are subjected to fractional distillation to isolate MCFAs (i.e., caprylic and capric acids). The MCFAs are then esterified with glycerin to produce a crude MCT product that is purified using traditional oil processing procedures.

Nisshin OilliO states that specific ratios of edible vegetable oil and MCT are combined with a food-grade lipase⁽²⁾ at a controlled temperature to produce a crude oil containing MCFAs (approximately 12 percent) and long-chain fatty acids (LCFAs) randomly attached to the glycerol backbone. The oil is then filtered, deacidified, bleached, deodorized, and mixed to produce the food-grade tailored triglycerides (12 percent MCFAs) ingredient. The final product is predominantly triglycerides (96-97 percent), with the remainder as diglycerides. The ingredient is tested to confirm compliance with specifications and absence of residual lipase activity.

Nisshin OilliO provides specifications for the food-grade tailored triglycerides (12 percent MCFAs) ingredient. The ingredient is described as a clear, liquid oil, with a MCFA content of 11.1-12.5 g/100 g (percent of fatty acids) and refractive index of 1.4665-1.4715 at 20 degrees Celsius. Specifications are also stated for lead and oil quality parameters.

Nisshin OilliO intends to use the tailored triglycerides (12 percent MCFAs) ingredient as an edible oil in home cooking, salad dressings, vegetable-oil spreads, and frozen dinners (including meat and poultry products). Nisshin OilliO considers these uses to be substitutional for edible vegetable oils commonly consumed by the U.S. population, and not to increase overall consumption of vegetable oils.

Nisshin OilliO provides an eaters-only estimate of intake of the tailored triglycerides (12 percent MCFAs) ingredient using the 2001-2002 National Health and Nutrition Examination Survey dietary intake data. In each food category, Nisshin OilliO calculated intake based on maximum use levels of raw ingredients obtained from standard recipe files from the United States Department of Agriculture (USDA) 1994-96, 1998 Continuing Survey of Food Intakes by Individuals. Mean and 90^th percentile intakes of the tailored triglycerides (12 percent MCFAs) ingredient are estimated to be approximately 11 and 31 g/p/d, respectively.

Nisshin OilliO considers the safety of the tailored triglycerides (12 percent MCFAs) ingredient to be supported by studies of structurally-related tailored triglycerides containing MCFAs and LCFAs, as well as studies of MCTs and LCTs. Published studies of tailored triglycerides containing MCFAs and LCFAs indicate they are readily broken down and absorbed through well-known processes. The distribution and metabolic fates of MCFAs and LCFAs have been also described in review publications and elsewhere in the published literature. Based on published data and studies, Nisshin OilliO concludes that the components of the tailored triglycerides (12 percent MCFAs) ingredient have been consumed in the human diet with no toxic effects.

Nisshin OilliO summarizes the results of published studies and one unpublished study of the tailored triglycerides (12 percent MCFAs) ingredient. Nisshin OilliO concludes that the tailored triglycerides (12 percent MCFAs) ingredient has been shown to be non-genotoxic in an in vitro study, as well as non-toxic in acute and subchronic animal studies. Nisshin OilliO discusses the results of a published human study which they say showed that the tailored triglycerides (12 percent MCFAs) ingredient was well tolerated and no adverse effects were noted in serum lipids, clinical chemistry, ketone bodies, body fat percentage, or liver and renal functions.

During its evaluation of GRN 000217, FDA consulted with the Labeling and Consumer Protection Staff of the Food Safety and Inspection Service (FSIS) of 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 notes that because oils are commonly used in the production of meat and poultry products, FSIS does not have any objection to the use of the tailored triglycerides (12 percent MCFAs) ingredient as a supplementary source of vegetable oil used in the production of various meat and poultry products. If, however, Nisshin OilliO has questions about the use of tailored triglycerides (12 percent MCFAs) ingredient in meat and poultry products, Nisshin OilliO should direct such an inquiry to Dr. Robert Post, Director, Labeling and Consumer Protection Staff, Office of Policy, Program, and Employee Development, Food Safety and Inspection Service, 1400 Independence Ave., S.W., Suite 602, Annex, Washington, DC 20250-3700. The telephone number for that office is (202) 205-0279 and the telefax number is (202) 205-3625.

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) amends the Federal Food, Drug, and Cosmetic Act (FFDCA) to require that the label of a food that is or contains an ingredient that bears or contains a "major food allergen" declare the presence of the allergen (section 403(w)). FALCPA defines a "major food allergen" as one of eight foods or food groups (i.e., milk, eggs, fish, Crustacean shellfish, tree nuts, peanuts, wheat, and soybeans) or a food ingredient that contains protein derived from one of those foods. Issues associated with labeling food are the responsibility of ONPLDS.

Section 403(a) of the FFDCA provides that a food is misbranded if its labeling is false or misleading in any particular manner. Section 403(r) of the FFDCA lays out the statutory framework for a health claim. In describing the intended use of tailored triglycerides (12 percent MCFAs) ingredient and in describing the information that Nisshin OilliO relies on to conclude that the tailored triglycerides (12 percent MCFAs) ingredient is GRAS under the conditions of its intended use, Nisshin OilliO raises an issue under these labeling provisions of the FFDCA. This issue consists of physiological effects of tailored triglycerides (12 percent MCFAs) ingredient that Nisshin OilliO views as beneficial. If products that contain tailored triglycerides (12 percent MCFAs) ingredient bear any claims on the label or in labeling, such claims are the purview of ONPLDS. The Office of Food Additive Safety (OFAS) neither consulted with ONPLDS on this labeling issue nor evaluated the information in your notice to determine whether it would support any claims made about tailored triglycerides (12 percent MCFAs) ingredient on the label or in labeling.

In the notice, Nisshin OilliO states its intention to use tailored triglycerides (12 percent MCFA) in several food categories for which standards of identity exist in Title 21 of the Code of Federal Regulations. OFAS notes 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.

Based on the information provided by Nisshin OilliO, as well as other information available to FDA, the agency has no questions at this time regarding Nisshin OilliO's conclusion that the tailored triglycerides (12 percent MCFAs) ingredient is GRAS under the intended conditions of use as an oil in home cooking, salad dressings, vegetable-oil spreads, and frozen dinners (including meat and poultry). The agency has not, however, made its own determination regarding the GRAS status of the subject use of the tailored triglycerides (12 percent MCFAs) ingredient. As always, it is the continuing responsibility of Nisshin OilliO 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 responding to GRN 000217, as well as a copy of the information in this notice that conforms to the information in the proposed GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying on the homepage of OFAS (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).

Sincerely,

Laura M. Tarantino, Ph.D.
Director
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

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

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⁽¹⁾In its notice, Nisshin OilliO refers to the ingredient as "medium- and long-chain triacylglycerol (MLCT)-oil."

⁽²⁾The enzyme is the subject of a previous GRAS notice, GRN 000043