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U.S. Department of Health and Human Services

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Agency Additional Correspondence Letter GRAS Notice No. GRN 000156

Return to inventory listing: GRAS Notice Inventory

See also Generally Recognized as Safe (GRAS) and about the GRAS Notice Inventory


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 000156

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 000156. The Burdock Group initially submitted GRN 000156, 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 August 6, 2004, filed it on August 11, 2004, and designated it as GRN 000156; FDA also received a submission dated September 29, 2004, on October 18, 2004, and added it as an amendment to GRN 000156. The subjects of the notice are tomato lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract. The notice informed FDA of the view of LycoRed that tomato lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract are GRAS, through scientific procedures, for use as ingredients in a number of food categories at a maximum final concentration of lycopene in food of 10 milligrams per kilogram (mg/kg).1 In a letter dated February 7, 2005, FDA informed LycoRed that the agency had no questions at that time regarding LycoRed’s conclusion that the subjects of the notice are GRAS under the intended conditions of use.

In a letter received October 16, 2007, the Burdock Group informed FDA of LycoRed’s determination that tomato lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract are GRAS for use in medical foods at levels not to exceed 3 mg lycopene per 100 kilocalories (mg/kcal) or 36 mg of lycopene per day (mg/d). 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 supplement. 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 the intake of medical foods containing lycopene (as proposed in the 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 the use of tomato lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene is generally recognized as safe as currently used in various food categories described in GRN 000156 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 lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract are GRAS for use in medical foods does not address the question of whether any particular food product that contains lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract 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 lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract are GRAS for use in medical foods, FDA did not consider whether section 301(ll) or any of its exemptions apply to foods containing lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract. Accordingly, this response should not be construed to be a statement that foods that contain lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract, if introduced or delivered for introduction into interstate commerce, would not violate section 301(ll).

Conclusions

Based on the information provided by LycoRed in GRN 000156, the supplement received, and other information available to FDA, the agency has no questions at this time regarding LycoRed’s conclusion that lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract are 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 lycopene extract 6 percent, tomato lycopene extract 1.5 percent, and crystallized tomato lycopene extract. 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 000156, 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 http://www.fda.gov. 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.

 

Sincerely,

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


 



 

1LycoRed 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.