Agency Response Letter GRAS Notice No. GRN 000215
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CFSAN/Office of Food Additive Safety
September 27, 2007
Dr. Dean Stull
Chief Science Officer
7007 Winchester Circle, Suite 120
Boulder, CO 80301
Re: GRAS Notice No. GRN 000215
Dear Dr. Stull:
The Food and Drug Administration (FDA) is responding to the notice, dated October 16, 2006, that you submitted 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 notice on October 23, 2006, filed it on October 30, 2006, and designated it as GRN No. 000215. Efficas, Inc. (Efficas) provided additional information, dated April 12, 2007, in support of this notice.
The subject of the notice is Actinidia arguta fruit extract (A. arguta fruit extract). The notice informs FDA of the view of Efficas that A. arguta fruit extract is GRAS, through scientific procedures, for use as an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, grain products and pastas, candies, jams and jellies, milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, and snack foods at a level of 600 milligrams (mg) per reference amount of each product customarily consumed per eating occasion. (1)
As part of its notice, Efficas includes the report of a panel of individuals (Efficas' GRAS panel) who evaluated the data and information that are the basis for Efficas' GRAS determination. Efficas considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. Efficas' GRAS panel discusses A. arguta fruit extract's identity, composition, specifications, method of manufacture, intended uses, and dietary intake estimates. Efficas' GRAS panel also discusses published and unpublished safety studies of A. arguta fruit extract and similar preparations of other Actinidia species. Based on this review, Efficas' GRAS panel concludes that A. arguta fruit extract that meets appropriate food grade specifications and is manufactured in accordance with current good manufacturing practices (GMP) is GRAS, by scientific procedures, under the conditions of its intended use.
Efficas provides information about the identity, composition, specifications and method of manufacture of A. arguta fruit extract. A. arguta fruit extract is obtained from the fruit of A. arguta, a kiwi plant also known by the common name hardy kiwi. A. arguta fruit extract is manufactured by a hot water extraction process. Efficas states that the A. arguta fruits is harvested, sliced, dried, and cooked in hot water. After cooking, the insoluble components are removed by filtration. Following filtration, the liquid is concentrated by evaporation to produce the final product, that may be in the form of a liquid concentrate or a dried tan powdered concentrate. Efficas states that water is the only solvent used in the process and all processing aids used in the manufacture of the powder concentrate are appropriate for food use. Efficas states that A. arguta fruit extract is produced in accordance with current GMP and meets appropriate food-grade specifications. Efficas provides product specifications for A. arguta fruit extract, including specifications for moisture, carbohydrate, protein, ash, fat, total organic acids, heavy metals, lead, and microbiological specifications.
Efficas estimates the intake of A. arguta fruit extract from its intended use in the food categories listed above. These estimates were derived from the USDA Continuing Survey of Food Intakes by Individuals (CSFII) 1994-1996. Efficas estimates that the intake of A. arguta fruit extract under the conditions of its intended use would be 2.4 grams/person/day (g/p/d) at the mean and 4.4 g/p/d at the 90th percentile. Efficas states that the background consumption of kiwi fruit (A. deliciosa) in the United States is reported to be 3.6 g/p/d, and that on a dry weight basis, the estimated intake of the A. arguta fruit extract is within the range of the calculated per capita consumption of kiwi fruit in the United States. Efficas states that the use of A. arguta fruit extract in food and beverage products is self-limiting due to its pH and textural properties.
Efficas maintains that A. arguta fruit extract is GRAS for the intended use based on its compositional similarity to the A. arguta fruit, an edible fruit from which the extract is derived, and to the fruit of the taxonomically related common green kiwi, A. deliciosa. To support this view, Efficas performed and describes a comparative analysis of A. arguta fruit extract to the whole-fruit of A. arguta and to the whole-fruit of A. deliciosa. As part of this compositional analysis, Efficas discusses the levels and safety of quercetin present in A. arguta fruit extract. Based on this analysis and generally available information, Efficas concludes that the composition of A. arguta fruit extract is similar to the composition of the A. arguta and A. deliciosa whole-fruit, and as such there is no concern for potential increase in exposure of any of the constituents of the fruit as a result of the concentration process used to manufacture the ingredient, nor are there any anticipated adverse effects on human health from any of the components of the ingredient at estimated intake levels.
In addition to its safety conclusion based on comparative chemical analysis, Efficas discusses the history of the food use of the A. arguta fruit and describes published and unpublished studies relevant to the safety of A. arguta fruit extract, including studies relating to allergenic potential. Efficas describes published preclinical studies conducted with different types of kiwi extracts and published clinical studies using various kiwi fruit and juice test articles. Efficas also describes an unpublished in vitro study of mutagenic potential of the A. arguta fruit extract, and various unpublished subchronic and chronic toxicological studies of the extract conducted in rodents; Efficas notes that there were no adverse effects. Efficas considers that the results of the various published and unpublished studies described in the notice provide corroborative support to its conclusion that A. arguta fruit extract is GRAS for the intended use. With respect to allergenic potential, Efficas states that there is evidence to suggest that kiwi fruit allergens are heat labile, and thus heated A. arguta fruit extract, as in the subject of this GRAS notice, will likely lack allergenic potential. Efficas further states that the A. arguta fruit extract will be labeled as originating from hardy kiwi fruit; Efficas anticipates that individuals with kiwi fruit allergy will avoid ingestion of this product because of this labeling. Issues associated with labeling food are the responsibility of the Center for Food Safety and Applied Nutrition's Office of Nutritional Products, Labeling, and Dietary Supplements.
Standards of Identity
In the notice, Efficas states its intention to use A. arguta fruit extract in several food categories, including foods for which standards of identity exist, located in Title 21 of the Code of Federal Regulations. We note 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 Efficas, as well as other information available to FDA, the agency has no questions at this time regarding Efficas' conclusion that A. arguta fruit extract is GRAS under the intended conditions. The agency has not, however, made its own determination regarding the GRAS status of the subject use of A. arguta fruit extract. As always, it is the continuing responsibility of Efficas 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 000215, 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 the Office of Food Additive Safety (on the Internet at http://www.cfsan.fda.gov/~lrd/foodadd.html).
Laura M. Tarantino, Ph.D.
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition
(1)Reference amounts customarily consumed are listed in 21 CFR 101.12.