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CFSAN/Office of Food Additive Safety
April 8, 2011
James T. Heimbach, Ph.D., F.A.C.N.
923 Water Street
P.O. Box 66
Port Royal, VA 22535
Re: GRAS Notice No. GRN 000301
Dear Dr. Heimbach
The Food and Drug Administration (FDA) is responding to your supplement dated September 10, 2010, that you sent regarding changes in the specifications for the subject of GRN 000301. You submitted GRN 000301 on behalf of BioVittoria 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). The subject of the notice is Siraitia grosvenorii Swingle (Luo Han Guo) fruit extract (SGFE). The notice informed FDA of the view of BioVittoria that SGFE is GRAS, through scientific procedures, for use as a sweetener and flavor enhancer in foods, excluding meat and poultry products, at levels determined by current good manufacturing practices (cGMP), as well as use as a table top sweetener. In a letter dated January 15, 2010, FDA informed you that the agency had no questions at that time regarding BioVittoria’s conclusion that SGFE is GRAS under the intended conditions of use.
In a letter dated September 10, 2010, you informed FDA of BioVittoria’s intent to add 0.75 percent food-grade citric acid during the manufacture of SGFE, thereby reducing the pH of the final product from 6.0 ±0.5 (the original specification) to about 4.5. BioVittoria notes that citric acid is affirmed GRAS under 21 CFR184.1033 for use in food processing with no limitation other than cGMP. BioVittoria concludes that SGFE manufactured using the new specifications remains GRAS under the intended conditions of use.
Based on the information provided by BioVittoria in GRN 000301, the supplement dated September 10, 2010, and other information available to FDA, the agency has no questions at this time regarding BioVittoria’s conclusion that SGFE 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 SGFE. As always, it is the continuing responsibility of BioVittoria 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 000301, 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 at www.fda.gov/grasnoticeinventory.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition