Agency Response Letter GRAS Notice No. GRN 000595

Recently Published GRAS Notices and FDA Letters

CFSAN/Office of Food Additive Safety

November 12, 2015

Noriko Horie
Pharma Foods International Co., Ltd.
1-49 Goryo-Ohara, Nishikyo-ku,
Kyoto 615-8245
JAPAN

Re: GRAS Notice No. GRN 000595

Dear Ms. Horie:

The Food and Drug Administration (FDA) is responding to the notice, dated August 3, 2015, 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 August 6, 2015, filed it on September 1, 2015, and designated it as GRAS Notice No. GRN 000595.

The subject of the notice is gamma-aminobutyric acid (GABA). The notice informs FDA of the view of Pharma Foods International Co., Ltd. that GABAis GRAS, through scientific procedures, for use as an ingredient in snack bars, carbonated drinks, energy drinks, flavored drinks, powdered drinks, sports drinks, flavored milk and milk drinks, yogurts, vegetable juices, breakfast cereals, processed cheese, chewing gum, coffee, tea, hard candies, soft candies, and chocolates at a level of 100 mg per serving which is equivalent to 0.0416–0.667%.

In a letter sent to us by e-mail dated November 10, 2105, you withdrew your notice. Given your letter, we ceased to evaluate your GRAS notice, effective November 10, 2015, 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 000595, 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/grasnoticeinventory.

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