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Agency Response Letter GRAS Notice No. GRN 000647

Recently Published GRAS Notices and FDA Letters

See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

October 14, 2016

Susan Cho, Ph.D.
Glycom A/S
NutraSource, Inc.
6309 Morning Dew Court
Clarksville, MD 21029

Re: GRAS Notice No. GRN 000647

Dear Dr. Cho:

The Food and Drug Administration (FDA) is responding to the notice, dated April 1, 2016, that you submitted on behalf of Samyang Corporation 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 April 6, 2016, filed it on May 17, 2016, and designated it as GRAS Notice No. GRN 000647.

The subject of the notice is D-psicose. The notice informs FDA of the view of Samyang Corporation that D-psicose is GRAS, through scientific procedures, for use as a sugar substitute and/or flavor modifier in food applications at use levels ranging from 1 to 100%; selected (low or reduced calorie) bakery products, alcoholic beverages (as a flavor modifier), soft drinks, fruit juice and fruit-flavored drinks, yogurt, frozen dairy desserts, hard and soft candies, chocolate, chewing gums, coffee mix, sauce, fat-based cream, sugar substitutes, nutrition bars, meal replacement shakes, and medical foods.

In an email dated October 11, 2016, you asked that FDA cease to evaluate your notice in order for you to revise the notice in response to issues raised by FDA during the present review. Given your request, we ceased to evaluate your GRAS notice, effective October 11, 2016, 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 000647, 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 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

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