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U.S. Department of Health and Human Services

Food

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Agency Response Letter GRAS Notice No. GRN 000346

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

October 6, 2010

Miriam Lewensztain
VitaGac, LLC
In care of Law Offices of Shula Barash
9454 Wilshire Blvd, Suite 500
Beverly Hills, CA 90212

Re: GRAS Notice No. GRN 000346

Dear Ms. Lewensztain:

The Food and Drug Administration (FDA) is responding to the notice, dated June 14, 2010, that you submitted 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 June 24, 2010, filed it on June 28, 2010, and designated it as GRAS Notice No. GRN 000346.

The subject of the notice is freeze-dried fruit gac powder. The notice informs FDA of the view of VitaGac, LLC that freeze-dried fruit gac powder is GRAS, through scientific procedures, for use as an ingredient in juice mixtures or beverages, nutritional bars, and functional foods as a source of lycopene and beta carotene.

In an electronic mail message dated September 10, 2010, you withdrew your notice. Given your electronic mail message, we ceased to evaluate your GRAS notice, effective September 10, 2010, the date that we received your electronic mail message.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000346, 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