Agency Response Letter GRAS Notice No. GRN 000247
CFSAN/Office of Food Additive Safety
October 7, 2008
Nga L.Tran, Dr. P.H, M.P.H.
1150 Connecticut Ave., NW
Washington, DC 20036
Re: GRAS Notice No. GRN 000247
Dear Dr. Tran:
The Food and Drug Administration (FDA) is responding to the notice, dated April 4, 2008, that you submitted on behalf of TIC Gums 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 April 7, 2008, filed it on April 9, 2008, and designated it as GRAS Notice No. GRN 000247.
The subject of the notice is modified gum acacia (MGA). The notice informs FDA of the view of TIC Gums that MGA is GRAS, through scientific procedures, for use as an emulsifier in icings, salad dressings, sauces, pure fruit juices (100%), select fruit flavored drinks, select beverages, select breads (whole grain and high fiber breads), and select cereals (low fat, low sugar and high fiber health foods) at levels from 350 to 10,000 milligrams per kilogram (mg/kg).
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 non-standardized foods. Our use of "modified gum acacia (MGA)" 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 Office of Nutrition, Labeling and Dietary Supplements in the Center for Food Safety and Applied Nutrition.
TIC Gums includes the report of a panel of individuals (TIC Gums' GRAS Panel) who evaluated the data and information that are the basis for TIC Gums' GRAS determination. TIC Gums considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. TIC Gums' GRAS panel evaluated published toxicity data and estimates of dietary exposure from intended uses of MGA, acacia,(1) and modified food starch. Based on this review, TIC Gums' GRAS panel concluded that MGA is GRAS under the conditions of its intended use.
TIC Gums provides information about the identity, composition, and method of manufacture of MGA. TIC Gums describes MGA as a cold-water soluble hydrocolloid; it is identified by the Chemical Abstract Services (CAS) registry number 455885-22-0. MGA is produced by reacting acacia with 1-octenyl succinic anhydride (OSA) in a production process that is similar to that used to produce modified food starch-OSA (21 CFR 172.892(d)). TIC Gums states that all of the ingredients used in the process are food grade. TIC Gums provides specifications for MGA, including the specifications for residual OSA (≤ 0.3 percent), lead (≤ 2 mg/kg), and microbiological criteria.
TIC Gums addresses the potential allergenicity of MGA. TIC Gums states that neither MGA nor its glycoprotein fraction is expected to be of any greater concern for allergenicity than unmodified acacia. TIC Gums notes that FDA found that the evidence for the allergenic potential of acacia was extremely weak (70 FR 8033; February 17, 2005).
TIC Gums estimates the daily intake of MGA. TIC Gums notes that the Flavor and Extract Manufacturers Association granted MGA GRAS status in 2003 for use in flavorings in a variety of food categories. TIC Gums estimates a cumulative maximum estimated daily intake of MGA of 524 mg per day (mg/day) for users two years and older by combining current uses (270 mg/day) and the intended new uses that are the subject of this notice.
TIC Gums discusses the safety of MGA. In its discussion, TIC Gums includes published and unpublished toxicity data on MGA, acacia, and modified food starch. TIC Gums considers published and unpublished data from adsorption, distribution, metabolism and excretion studies. Among the studies considered were acute, subchronic and genotoxicity studies with MGA; acute, subchronic, chronic, reproductive/developmental toxicity and genotoxicity studies with acacia; and a subchronic study with modified food starch. Based on its consideration of these data, TIC Gums concludes that MGA is safe for its intended use in foods.
Standards of Identity
In the notice, TIC Gums states its intention to use MGA 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.
Section 301(ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
The Food and Drug Administration Amendments Act of 2007, which was signed into law on September 27, 2007, amends the FFDCA to, among other things, add section 301(ll). Section 301(ll) of the FFDCA prohibits the introduction or delivery for introduction into interstate commerce of any food that contains a drug approved under section 505 of the FFDCA, a biological product licensed under section 351 of the Public Health Service Act, or a drug or a biological product for which substantial clinical investigations have been instituted and their existence made public, unless one of the exemptions in section 301(ll)(1)-(4) applies. In its review of TIC Gums' notice that MGA is GRAS for use in icings, salad dressings, sauces, pure fruit juices (100%), select fruit flavored drinks, select beverages, select breads (whole grain and high fiber breads), and select cereals (low fat, low sugar and high fiber health foods), FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing MGA. Accordingly, this response should not be construed to be a statement that foods that contain MGA, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by TIC Gums, as well as other information available to FDA, the agency has no questions at this time regarding TIC Gums' conclusion that MGA 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 MGA. As always, it is the continuing responsibility of TIC Gums 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 000247, 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)Acacia (gum arabic) is affirmed GRAS for certain uses under 21 CFR 184.1330 and is approved as a food additive for use in alcoholic beverages under 21 CFR 172.780.