Agency Response Letter GRAS Notice No. GRN 000636
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See also Generally Recognized as Safe (GRAS).
CFSAN/Office of Food Additive Safety
August 4, 2016
Susan Cho, Ph.D.
6309 Morning Dew Court
Clarksville, MD 21029
Re: GRAS Notice No. GRN 000636
Dear Dr. Cho:
The Food and Drug Administration (FDA) is responding to the notice, dated March 8, 2016, that you submitted on behalf of ECA Healthcare, Inc. (ECA) in accordance with the agency’s proposed regulation, proposed 21 Code of Federal Regulations (CFR) 170.36 (62 FR 18938; April 17, 1997; Substances Generally Recognized as Safe (GRAS); the GRAS proposal). FDA received the notice on March 16, 2016, filed it on March 25, 2016, and designated it as GRAS Notice No. GRN 000636.
The subject of the notice is phosphatidylserine derived from sunflower lecithin (sunflower PS). The notice informs FDA of ECA’s view that sunflower PS is GRAS, through scientific procedures, for use as a nutrient and as an alternative to other sunflower PS sources at levels up to 100 milligrams (mg) per serving in dairy product analogs (imitation milk and soy milk), grain products (nutritional bars: breakfast, granola, and protein), milk products (flavored milk and milk drinks, excluding fluid milk, milk-based meal replacements, and yogurt), and processed fruits and fruit juices (fruit flavored drinks); at levels of 50 mg per serving in breakfast cereals and milk (fluid: regular, filled, buttermilk, and dry reconstituted); and at levels up to 300 mg per day in medical foods.
In an email dated July 1, 2016, you withdrew your notice in order to collect further information regarding comments FDA raised in an email sent to you on June 20, 2016. Given your email, we ceased to evaluate your GRAS notice, effective July 1, 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 000636, 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.
Antonia Mattia, Ph.D.
Division of Biotechnology and GRAS Notice Review
Office of Food Additive Safety
Center for Food Safety and Applied Nutrition