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Specializing in FDA Regulatory Matters

Generally Recognized as Safe (GRAS) Notification Submissions

EAS Consulting Group, LLC. is an industry leader in submitting GRAS Notices to FDA for review.

Below is a partial list of GRAS Notices EAS has submitted on behalf of its clients that have received “no objections” letters from FDA:

GRN 470 – Ethyl cellulose
GRN 413 – Beta glucans derived from Ganoderma lucidum mycelium
GRN 411 – Egg yolk-derived phospholipids
GRN 343 – Wheat bran extract composed primarily of xylo- and arabinoxylo-oligosaccharides
GRN 311 – Krill-based phosphatidylserine
GRN 294 – Haematococcus pluvialis extract containing astaxanthin esters
GRN 279 – Phosphatidylserine derived from fish
GRN 237 – Alkyl polyglycosides
GRN 226 – Lecithin derived from krill
GRN 223 – Phosphatidylserine
GRN 218 – Bacteriophage P100 preparation from Listeria innocua

In addition, AAC Consulting Group, LLC., which was acquired by EAS Consulting Group in October 2006, successfully submitted the following GRAS notifications with no objections:

GRN 202 – Polyoxyethanyl-alpha-tocopheryl sebacate (PTS)
GRN 200 – Tailored triglycerides enriched in omega-3 fatty acids from fish oil
GRN 198 – Bacteriophage P100 preparation from Listeria innocua
GRN 158 – Sodium iron EDTA
GRN 135 – ε-Polylysine
GRN 27 – Dextranase from Chaetomium gracile

Also, EAS/AAC have helped numerous other firms documented the safety of ingredients through Independent (self) GRAS determinations and have helped firms submit GRAS Notices directly to FDA under their own company names.