Agency Response Letter GRAS Notice No. GRN 000324
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CFSAN/Office of Food Additive Safety
July 9, 2010
House Wellness Foods Corporation
Imoji 3-20, Itami, Hyogo
Re: GRAS Notice No. GRN 000324
Dear Mr. Matsumoto:
The Food and Drug Administration (FDA) is responding to the notice, dated January 29, 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 February 05, 2010, filed it on February 18, 2010, and designated it as GRAS Notice No. GRN 000324.
The subject of the notice is heat-killed Lactobacillus plantarum. The notice informs FDA of the view of House Wellness Foods Corporation that heat-killed L. plantarum is GRAS, through scientific procedures, for use an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, dairy product analogs, fats and oils, frozen dairy desserts, grain products and pastas, milk and milk products, plant protein products, processed fruits and fruit juices, processed vegetables and vegetable juices, soft candy, and soups and soup mixes, excluding meat and poultry, at a maximum level of 150 milligram per serving.
In a letter dated June 25, 2010, you asked that FDA cease to evaluate your notice. Given your request, we ceased to evaluate your GRAS notice, effective July 7, 2010, the date that we received your letter.
In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000324, 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.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition