Agency Response Letter GRAS Notice No. GRN 000240
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CFSAN/Office of Food Additive Safety
October 24, 2008
Mark L. Itzkoff
Olsson Frank Weeda Terman Bode Matz PC
Attorneys At Law
1400 Sixteenth Street, NW
Washington, DC 20036
Re: GRAS Notice No. GRN 000240
Dear Mr. Itzkoff:
The Food and Drug Administration (FDA) is responding to the notice, dated January 18, 2008, that you submitted on behalf of PURAC 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 January 22, 2008, filed it on January 28, 2008, and designated it as GRAS Notice No. GRN 000240.
The subject of the notice is corn, cane, or beet sugar cultured with Lactobacillus paracasei subsp. paracasei, Bacillus coagulans LA-1, or Propionibacterium freudenreichii subsp. Shermanii, or mixtures of these microorganisms. The notice informs FDA of the view of PURAC that corn, cane, or beet sugar cultured with L. paracasei subsp. paracasei, B. coagulans LA-1, and/or P. freudenreichii subsp. shermanii is GRAS, through scientific procedures, for use as an antimicrobial agent in meat and poultry products at a level of 4.8 percent.(1) For the purpose of this letter, FDA refers to the substance that is the subject of GRN 000240 as cultured cane, corn, or beet sugar.
As part of its notice, PURAC includes the report of a panel of individuals (PURAC's GRAS panel) who evaluated the data and information that are the basis for PURAC's GRAS determination. PURAC considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. PURAC's GRAS panel evaluated the method of production, including information about the microorganisms, product specifications, as well as published studies. Based on this review, PURAC's GRAS panel concluded that cultured cane, corn, or beet sugar, meeting appropriate food grade specifications, is GRAS, by scientific procedures, under the conditions of its intended use.
PURAC provides information about the identity, composition, method of manufacture and specifications of cultured cane, corn, or beet sugar. PURAC manufactures cultured cane, corn, or beet sugar by the fermentation of sucrose, originating from sugar cane or beet, or dextrose, originating from corn. The sugar substrate is fermented to organic acids, primarily lactic acid, by L. paracasei subsp. paracasei, B. coagulans LA-1, or P. freudenreichii subsp. shermanii, or mixtures of these microorganisms. PURAC describes standard microbiological procedures for the manufacture of its cultured-sugar ingredient. PURAC states that lactic acid, in the form of sodium and potassium salts, comprises 55 to 85 percent of cultured cane, corn, or beet sugar. PURAC states that its cultured-sugar ingredient also contains small amounts of sodium or potassium salts of acetic acid, succinic acid, formic acid, 2-hydroxybutyric acid and propionic acid, as well as glucose, fructose, and poly/oligosaccharides, consisting of glucose, galactose, rhamnose, glucosamine, mannose, and xylose. PURAC states that its cultured cane, corn, or beet sugar is produced in accordance with current good manufacturing practices and all raw materials and processing aids used in the manufacture of the ingredient are permitted for use in food in the United States. PURAC provides product specifications for cultured cane, corn, or beet sugar, among which are common microbiological specifications as well as specifications for organic acids, sugars, and a limitation for lead.
PURAC describes generally available information about the safety of the microorganisms used in the production of cultured cane, corn, or beet sugar. PURAC states that these are non-pathogenic, non-toxigenic organisms commonly used in the food industry for the production of enzymes and cheese, and also are used as "probiotics."
PURAC's notice provides an estimated daily intake of cultured cane, corn, or beet sugar. The estimate was based the 2003-2004 National Health and Nutrition Examination Survey dietary intake data. On an all user basis, the mean intake of cultured cane, corn, or beet sugar by the total United States population from all intended food uses is estimated to be approximately 6.55 grams per person per day (g/p/d). The 90th percentile all-user intake of cultured cane, corn, or beet sugar by the total United States population from all intended food uses is estimated to be 12.31 g/p/d.
PURAC's notice discusses information pertaining to the safety of cultured cane, corn, or beet sugar. PURAC states that cultured cane, corn, or beet sugar is safe under the intended conditions of use on the basis that the ingredient consists of substances that are either approved for use in food in the United States, are commonly consumed in the diet, or are endogenous to the body. PURAC also states that the safety of some of the components of this cultured ingredient is further supported by published animal and clinical studies.
Use in Meat and Poultry Products
During its evaluation of GRN 000240, FDA consulted with the Labeling and Program Delivery Division 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 does not object to the use of cultured cane, corn, or beet sugar at up to 4.8 percent of the product formula as an antimicrobial agent in enhanced meat and poultry products (e.g., beef or chicken injected with a solution containing cultured cane, corn, or beet sugar) and ready-to-eat meat and poultry products (e.g., hot dogs and luncheon meat) that provide for the use of ingredients of this type. Concerning ingredient labeling, FSIS believes that "cultured sugar" is an appropriate name for cultured cane or beet sugar and is consistent with 21 CFR 101.4 (b)(5), 101.4 (b)(20), and 184.1854. For cultured corn sugar, FSIS believes that an appropriate ingredient name that is consistent with 21 CFR 184.1857 is "cultured corn sugar" or "cultured dextrose." Any further questions regarding use in meat and poultry products should be directed to Dr. John Hicks, Jr., Director, Risk Management Division, Office of Policy and Program Development,(2) 1400 Independence Ave., S.W., Room 3549, South Agriculture Building, Washington, DC 20250-3700. The telephone number for that office is (202) 205-0210 and the telefax is (202) 720-0582.
Section 301 (ll) of the Federal Food, Drug, and Cosmetic Act (FFDCA)
The Food and Drug Administration Amendments Act of 2007, that 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 PURAC's notice that cultured cane, corn, or beet sugar is GRAS for use as an antimicrobial agent in meat and poultry products, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing cultured cane, corn, or beet sugar. Accordingly, this response should not be construed to be a statement that foods that contain cultured cane, corn, or beet sugar, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).
Based on the information provided by PURAC, as well as other information available to FDA, the agency has no questions at this time regarding PURAC's conclusion that cultured cane, corn, or beet sugar is GRAS under the intended conditions. The agency has not, however, made its own determination regarding the GRAS status of the subject use of cultured cane, corn, or beet sugar. As always, it is the continuing responsibility of PURAC 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 000240, 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
cc: Dr. John Hicks, Jr. DVM, MPH
Risk Management Division
Office of Policy and Program Development
Food Safety and Inspection Service
U. S. Department of Agriculture
1400 Independence Avenue, S.W., Room 3549, South Agriculture Building
Washington, DC 20250-3700
(1)The original notice of January 18, 2008, was also for an additional use as a flavoring agent. By an e-mail message of September 2, 2008, PURAC narrowed the scope of GRN 000240 to the use as an antimicrobial agent.
(2)Effective June 1, 2008, the Office of Policy and Program Development of FSIS has transferred the review process of ingredient submissions from the Labeling and Program Delivery Division to the Risk Management Division.