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CFSAN/Office of Food Additive Safety
June 2008
A substance that will be added to food is subject to premarket approval by FDA unless its use is generally recognized as safe (GRAS) by qualified experts.(1) On April 17, 1997, FDA issued a proposed rule (the GRAS proposal; 62 FR 18938) that would establish a notification procedure whereby any person may notify FDA of a determination by that person that a particular use of a substance is GRAS. Although the proposed notification procedure is not yet final, FDA has already received several notices. As described in the GRAS proposal, the agency is evaluating whether each submitted notice provides a sufficient basis for a GRAS determination and whether information in the notice or otherwise available to FDA raises issues that lead the agency to question whether use of the substance is GRAS. Following this evaluation, FDA replies to the notifier by letter.
In general, FDA's response has been in one of three categories:
In the GRAS proposal, FDA announced its intention to maintain an inventory of GRAS notices and the agency's response to those notices. The main page of the Inventory of GRAS Notices lists all notices that FDA has received, describes FDA's response as one of the three general categories described above, and provides a hyperlink to the actual response letter. The table below, which is a separate part of the Inventory of GRAS Notices, lists the notices that FDA received in the year 2008. Importantly, the table below lists all GRAS notices received in the year 2008, regardless of whether the notice is pending at FDA or has come to closure.
The table below:
This table is current as of May 31, 2008, and therefore does not show any new notices filed by FDA, or response letters issued by FDA, after that date. This table will be updated approximately monthly.
| GRN No. | Notifier | Substance | Intended Use | GRP # | Basis | Date of filing | Closure |
|---|---|---|---|---|---|---|---|
| 253 | Cargill, Incorporated | Rebaudioside A purified from Stevia rebaudiana (Bertoni) | General-purpose sweetener in foods generally, excluding meat and poultry products, at levels determined by current good manufacturing practices | Scientific procedures | May 20, 2008 | ||
| 252 | Whole Earth Sweetener Company LLC (a wholly owned subsidiary of Merisant Company) | Rebaudioside A purified from Stevia rebaudiana (Bertoni) | Sweetener in selected beverages (including sweetened teas, diet soft drinks, energy drinks and flavored waters) and cereals (oatmeal, cold cereal, and cereal bars) at levels ranging from 150 to 500 milligrams per kilogram (mg/kg); and as a tabletop sweetener at 30,000 mg/kg | Scientific procedures | May 13, 2008 | ||
| 251 | Vincent Mercogliano | Carbon monoxide | 0.4% carbon monoxide in a modified atmosphere of helium for treatment of fresh red meat prior to vacuum packaging for retail | Scientific procedures | May 8, 2008 | ||
| 250 | Arboris LLC | Pine tree phytosterol | For the existing uses of phytosterols in margarine and vegetable based spreads; yogurt and yogurt like products; milk-based juice beverages; ice cream and non-standardized ice cream products; cream cheese and cream cheese-like products; snack bars; salad dressing; standardized and non-standardized bread products; baked foods; beverages; dairy analogs; cheese and cream; breakfast cereal; mayonnaise; pasta and noodles; sauces; salty snacks; processed soups; puddings; confections; vegetarian meat analogs; fruit/vegetable juice; vegetable oils; egg products, including egg whites and substitute egg products | Scientific procedures | May 5, 2008 | ||
| 249 | SRA International Inc. | Capsiate | Ingredient in a variety of food categories to provide 1 milligram of capsiate per standard serving | Scientific procedures | May 14, 2008 | ||
| 248 | Compass Foods Pte Ltd | Sucrose fatty acid esters (alternate method of production) | As an emulsifier in fruit flavored beverages and beverage concentrates at levels up 50 parts per million | Scientific procedures | Apr. 10, 2008 | ||
| 247 | TIC Gums, Inc. | Modified gum acacia | As an emulsifier in pure fruit juices (100%), select fruit flavored drinks, select beverages (carbonated juices, oatmeal, and energy drinks and vitamin water), salad dressings, sauces, icing, select breads (whole grain and high fiber breads), and selected cereals (high fiber, low sugar, and low fat adult cereals) at levels that range between 350 and 10,000 parts per million | Scientific procedures | Apr. 9, 2008 | ||
| 246 | BioNeutra Inc. | Isomalto-oligosaccharides | As a sweetener in conventional foods at levels ranging from 1.5 to 15 grams per serving | Scientific procedures | Apr. 4, 2008 | ||
| 245 | NattoPharma ASA | Menaquinone-7 | As a nutrient supplement in dairy products, margarine substitutes, and dairy products including yoghurt, cottage cheese, hard cheeses, milk drinks and substitute products at levels up to 50 micrograms per day | Scientific procedures | Apr. 14, 2008 | ||
| 244 | Kohjin Co., Ltd. | Glutathione | Ingredient in several food categories, including meat products, at levels ranging from 5 to 300 milligrams per serving; and in milk- and soy-based infant formula at levels up to 0.167 grams per 100 milliliters | Scientific procedures | Feb. 14, 2008 | May 9, 2008 | |
| 243 | Bioenergy, Inc. | D-Ribose | Ingredient in beverages and beverage bases, coffee and tea, frozen dairy desserts and mixes, grain products and pasta, hard candy, milk products, processed fruits and fruit juices, processed vegetables and vegetable juices, and soft candy at levels ranging from 0.4 to 5.0 percent | Scientific procedures | Feb. 8, 2008 | ||
| 242 | Neptune Technologies and Bioressources | Krill oil | For use as a substitute for fish oils in non-alcoholic beverages, breakfast cereals, cheeses, frozen dairy desserts, milk products, processed fruit/fruit juices, and medical foods at levels that will provide not more than 2.2 grams per person per day of eicosapentaenoic acid and docosahexaenoic acid | Scientific procedures | Feb. 4, 2008 | ||
| 241 | Cypress Systems, Inc. | High-selenium yeast | Ingredient in baked products, non-alcoholic beverages, breakfast cereals, grain products and pastas, milk products, processed fruits/fruit juices, processed vegetables/ vegetables juices, commercial soups and soup mixes and medical foods as a source of selenium at levels yielding 5 micrograms selenium per serving | Scientific procedures | Jan. 30, 2008 | Apr. 9, 2008 | |
| 240 | PURAC | Corn, cane, or beet sugar cultured with Lactobacillus paracasei subsp. paracasei, Bacillus coagulans and Propionibacterium freudenreichii subsp. shermanii | Flavoring and antimicrobial agent in meat and poultry products | Scientific procedures | Jan. 28, 2008 | ||
| 239 | Biothera, Inc. | Yeast beta-glucan | Ingredient in a variety of baked goods, baking mixes, beverages, beverages bases, cereal, cereal products, dairy products analogs, milk, milk products, plant protein products, processed fruits, fruit juices, soft candy, soup, and soup mixes, at levels up to 200 milligrams per serving | Scientific procedures | Jan. 24, 2008 |
(1)In addition, a substance that is used in accordance with a sanction granted prior to September 6, 1958 is not subject to premarket approval.
