Agency Additional Correspondence Letter GRAS Notice No. GRN 000163
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CFSAN/Office of Food Additive Safety
January 26, 2007
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 your correspondence dated September 15, 2006, that you sent on behalf of LycoRed Natural Products Industries, Ltd. (LycoRed ) regarding LycoRed's additional uses for the subject of their GRAS Notice No. GRN 000163 (GRN 000163). You 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. In a letter dated August 8, 2005, FDA informed LycoRed that the agency had no questions at that time regarding the conclusion of LycoRed that tomato pulp powder, the subject of the notice, is GRAS under the intended conditions of use.
In a 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. In the September 15, 2006, letter, LycoRed listed the foods in which tomato pulp extract is no longer considered for use. LycoRed states that they will advise tomato pulp powder users that LycoRed's GRAS determination now supports the remaining categories listed in GRN 000163 and additional ones (i.e., beverages) as listed in Appendix B of the letter submitted. LycoRed concludes that the addition of beverages does not change the estimated level of lycopene consumption as they stated in GRN 000163.
Based on the information provided by LycoRed in GRN 000163, the supplement dated September 15, 2006, 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. 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 additional information submitted regarding GRN 000163, as well as a copy of the information in the 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).
Antonia Mattia, Ph.D.
Director Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition