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Agency Supplemental Correspondence Letter GRAS Notice No. GRN 000163

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CFSAN/Office of Food Additive Safety

September 15, 2010

George Burdock, Ph.D.
Burdock Group
801 N. Orange Ave.
Suite 710
Orlando, FL 32801

Re: GRAS Notice No. GRN 000163

Dear Dr. Burdock:

The Food and Drug Administration (FDA) is responding to your supplement received, October 16, 2007, that you sent on behalf of your client, LycoRed Natural Products Industries, Ltd. (LycoRed) regarding an additional use for the subject of GRN 000163. The Burdock Group initially submitted GRN 000163, on behalf of 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 GRN 000163. The notice informed FDA of the view of LycoRed that tomato pulp powder is GRAS, through scientific procedures, for use as an ingredient in a number of food categories at a maximum final concentration of lycopene in food of 20 milligrams per kilogram (mg/kg). In a letter dated August 8, 2005, FDA informed LycoRed that the agency had no questions at that time regarding LycoRed’s conclusion that the subject of the notice is GRAS under the intended conditions of use.

In a subsequent letter dated September 15, 2006, LycoRed informed the FDA of their determination that the addition of tomato pulp powder to other foods (i.e., beverages) is GRAS, while acknowledging that the use of tomato pulp powder in some of the foods listed in GRN 000163 is impractical and nonviable in the marketplace and that they, therefore, do not contribute to lycopene exposure. LycoRed concluded that the addition of beverages does not change the estimated level of lycopene consumption as projected in GRN 000163. In a letter dated January 26, 2007, FDA informed LycoRed that the agency had no questions at that time regarding LycoRed’s conclusion about the intended use in beverages.

In a letter received October 16, 2007, the Burdock Group informed FDA of LycoRed’s determination that the addition of tomato pulp powder is GRAS for use in medical foods at a level not to exceed 3 mg of lycopene per 100 kilocalories (mg/kcal) or 36 mg of lycopene per day (mg/d).(1) LycoRed based their determination on information submitted in the original GRAS notice as well as a review of more recent published studies and exposure information that was submitted in the supplements. As part of its October 16, 2007, supplement, LycoRed includes the report 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. The GRAS panel considers that intakes of medical foods containing lycopene (as proposed in the recent supplement), whether consumed as a sole source of nutrition or as a supplement to a diet where caloric needs are partially met by conventional foods, would not result in lycopene intakes that exceed the estimates of potential total lycopene intake presented in the original notice and considered by the GRAS panel to be safe. LycoRed’s GRAS panel concludes that tomato pulp powder is generally recognized as safe as currently used in various food categories described in GRN 000163 (and amended in the September 15, 2006, supplement) and for the intended use in medical foods.

Medical Foods

Section 5(b) of the Orphan Drug Act (ODA) defines a medical food as a food that is formulated to be consumed or administered enterally under the supervision of a physician and that is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. Section 403(q) of the Federal Food, Drug, and Cosmetic Act (FFDCA) lays out the statutory framework for nutrition labeling of food products. Section 403(r) of the FFDCA lays out the statutory framework for health claims and nutrient content claims. Under section 403(q)(5)(A)(iv) of the FFDCA and FDA’s implementing regulations in 21 CFR 101.9(j)(8), the requirements for nutrition labeling do not apply to medical foods as defined in section 5(b) of the ODA. Under section 403(r)(5)(A) and FDA’s implementing regulations in 21 CFR 101.13(q)(4) and 21 CFR 101.14(f)(2), the requirements for nutrient content claims and health claims do not apply to medical foods as defined in section 5(b) of the ODA. For your information, FDA’s response to LycoRed’s supplement that tomato pulp powder is GRAS for use in medical foods does not address the question of whether any particular food product that contains tomato pulp powder as an ingredient would be a medical food within the meaning of section 5(b) of the ODA and, thus, would be exempt from the requirements for nutrition labeling, nutrient content claims, and health claims.

Section 301(ll) of the 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 LycoRed’s supplement that tomato pulp powder is GRAS for use in medical foods, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing tomato pulp powder. Accordingly, this response should not be construed to be a statement that foods that contain tomato pulp powder, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).


Based on the information provided by LycoRed in GRN 000163, the supplements received, and 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 in medical foods. 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 responding to the October 16, 2007, supplement to GRN 000163, as well as a copy of the information in this notice that conforms to the information in the GRAS exemption claim (proposed 21 CFR 170.36(c)(1)), is available for public review and copying via the FDA home page at To view or obtain an electronic copy of the text of the letter, follow the hyperlinks from the “Food” topic to the “Food Ingredients and Packaging” section to the “Generally Recognized as Safe (GRAS)” page where the GRAS Inventory is listed.


Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition

(1)LycoRed notes that the energy content of medical foods is typically 200-400 kcal per serving, with a suggested intake of 1-3 servings per day. At the stated maximum use level of 36 mg lycopene/day, intake of medical foods containing these ingredients would be limited to 1200 kcal per day.

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