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Agency Response Letter GRAS Notice No. GRN 000613

Recently Published GRAS Notices and FDA Letters

See also Generally Recognized as Safe (GRAS).

CFSAN/Office of Food Additive Safety

March 8, 2016

David H. Bechtel, Ph.D., D.A.B.T.
David Clarke
DS & Lab Services Ltd.
291 Eulalie Avenue
Oshawa, Ontario, L1H 2B6

Re: GRAS Notice No. GRN 000613

Dear Mr. Clarke:

The Food and Drug Administration (FDA) is responding to the notice, dated September 17, 2015, that you submitted on behalf of Leahy Orchards, Inc.(Leahy) 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 December 2, 2015, filed it on December 15, 2015, and designated it as GRAS Notice No. GRN 000613.

The subject of the notice is dried apple peel powder (DAPP). The notice informs FDA of the view of Leahy that DAPP is GRAS, through scientific procedures, for use as an ingredient in fruits and fruit juices, vegetable juices, fortified foods and beverages, milk and milk products, bakery products, dairy products and substitutes, ready-to-eat cereal, sauces, dips, gravies, and condiments (excluding those under the United States Department of Agriculture’s jurisdiction) at a level ranging from 0.1 to 20%, based on the food category.

In electronic mail (email) sent on March 8, 2016, you withdrew your notice in order to collect the information regarding the subjects FDA raised during a teleconference with and in a subsequent email sent to you on March 2, 2016. Given your email, we ceased to evaluate your GRAS notice, without prejudice to submission of a new notice, effective March 8, 2016, the date that we received your email.

In accordance with proposed 21 CFR 170.36(f), a copy of the text of this letter responding to GRN 000613, 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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