Agency Response Letter GRAS Notice No. GRN 000163
CFSAN/Office of Food Additive Safety
August 8, 2005
George A. Burdock, Ph.D.
888 Seventeenth Street, NW
Washington, DC 20006
Re: GRAS Notice No. GRN 000163
Dear Dr. Burdock:
The Food and Drug Administration (FDA) is responding to the notice, dated January 31, 2005, that you submitted on behalf of LycoRed Natural Products Industries, Ltd. (LycoRed), 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 February 5, 2005, filed it on February 14, 2005, and designated it as GRAS Notice No. GRN 000163.
The subject of the notice is tomato pulp powder. The notice informs FDA of the view of LycoRed that the use of tomato pulp powder as a direct food ingredient is GRAS, through scientific procedures, resulting in a maximum of 20 milligram (mg) lycopene/kilogram (kg) of food in the following food categories: baked goods, ground meat products, meat analogues (vegetable protein-based), dairy products, soups and sauces.
Our use of the term "tomato pulp powder" in this letter should not be considered an endorsement or recommendation of this term as an appropriate common or usual name for the purpose of declaring this substance in the ingredient statement of foods that contain these ingredients. As stated in 21 CFR 101.4, 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. Issues associated with labeling and the appropriate common or usual name of a food are the responsibility of the Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS).
As part of its notice, LycoRed includes a summary of conclusions of a panel of individuals (LycoRed's GRAS panel) who evaluated the data and information that are the basis for LycoRed's GRAS determination. LycoRed considers the members of its GRAS panel to be qualified by scientific training and experience to evaluate the safety of substances added to food. LycoRed's GRAS panel evaluated the following: estimated dietary exposure; method of production of tomato pulp powder; nature and quantity of impurities; product specifications; and data, and information available from human clinical studies and pre-clinical toxicity studies with tomato products (e.g., tomato juice, tomato powder) and tomato lycopene extracts.(1) LycoRed's GRAS panel concluded that tomato pulp powder is GRAS for its intended use.
LycoRed describes the method of manufacture of tomato pulp powder, prepared from a hybrid, high lycopene variety of tomato (Lycopersicon esculentum (L.) Karst Ex. Farwell). Tomatoes are selected for high lycopene content, washed, crushed, and screened to remove stems and seeds. The resulting tomato juice is passed through a heat exchanger and centrifuged to separate the tomato pulp from tomato serum. LycoRed also notes that the ratios of tocopherols, phytoene, and phytofluene to lycopene are similar for ripe tomato, tomato pulp powder, and tomato lycopene extract (containing 6 percent lycopene).
Tomato pulp powder contains approximately one percent lycopene, with the balance consisting of proteins, sugars, dietary fibers, lipids, and other carotenoids. It is a dark free-flowing powder and contains trans lycopene (Chemical Abstract Service Registry Number 502-65-8) as the predominant carotenoid.
LycoRed provides microbiological specifications as well as specifications for moisture and contaminants, including pesticides, heavy metals, residual solvent. LycoRed provides stability experiments conducted with tomato pulp powder and concludes that lycopene from tomato pulp powder is chemically stable under various processing conditions and is stable as an ingredient in a variety of foods.
LycoRed discusses the intended uses of tomato pulp powder, noting that its use is largely self-limiting. At high levels, certain food items may acquire a strong tomato flavor. Further, tomato pulp powder would not be compatible with all food systems, due in part to technical limitations (e.g., solubility, aesthetics), cost, and limited or restricted use in fresh and standardized foods.
LycoRed notes that all of the major constituents in tomato pulp powder are normal constituents of commonly consumed foods. In GRN 000163, LycoRed cites several published clinical trials using dietary intervention with tomatoes and tomato products. In GRN 000156, LycoRed discussed studies conducted with lycopene and tomato lycopene extracts (5 percent and 6 percent).
Potential Labeling Issues
Section 403(a) of the Federal Food, Drug, and Cosmetic Act (FFDCA) provides that a food shall be deemed to be misbranded if its labeling is false or misleading in any particular. Section 403(r) of the FFDCA lays out the statutory framework for health claims. LycoRed describes the intended use of tomato pulp powder as having beneficial effects. Any claims concerning beneficial effects are under the purview of the ONPLDS. The Office of Food Additive Safety neither consulted with ONPLDS on potential beneficial effects nor evaluated the information in LycoRed's notice to determine whether it would support any claims made about lycopene on the label or in labeling.
Standards of Identity
In its notice, LycoRed states its intention to use tomato pulp powder in several food categories, including dairy products and baked goods for which a standard of identity exists. 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.
Use in Meat Products
During its evaluation of GRN 000163, FDA consulted with the Labeling and Consumer Protection Staff 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 requested that FDA advise LycoRed to seek regulatory guidance from FSIS, Labeling and Consumer Protection Staff, about the use of tomato pulp powder in meat products. LycoRed 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.
Based on the information provided by LycoRed, as well as other information available to FDA, the agency has no questions at this time regarding LycoRed's conclusion that tomato pulp powder 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 tomato pulp powder. As always, it is the continuing responsibility of LycoRed 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, as well as a copy of the information in your notice that conforms to the information in 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. 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
(1) "Tomato lycopene extract" refers to the ingredients described in GRN 000156 that contain several fat-soluble compounds present naturally in tomato, including a stated percentage (typically 6 percent) of lycopene.