Eggshell Membrane Safety Publication Leads to GRAS

CARTHAGE, Mo.NEM® (Natural Eggshell Membrane, from ESM Technologies,  is the subject of a safety manuscript newly published online by the journal Food and Chemical Toxicology.   The manuscript, entitled Safety evaluation of a natural eggshell membrane-derived product, evaluated NEMs safety via multiple in vitro and in vivo toxicological studies conducted by a variety of independent research labs.

The labs evaluated NEM for cytotoxicity, genotoxicity and oral toxicity (both single acute dose and 90-day repeated-dose) at doses up to fifty times the clinically tested human equivalent dose.  They found no signs of toxicity in any of the focus areas, demonstrating NEM is safe for human consumption at the standard daily dose of 500mg per day.

 Although a food-based product such as eggshell membrane would be expected to be inherently safe, we wanted to demonstrate that elevated levels of NEM® could be consumed with complete confidence. says Kevin J. Ruff, Ph.D., director of scientific & regulatory affairs for ESM.

Based on results from these safety studies, an independent expert panel determined NEM is Generally Recognized As Safe (GRAS), allowing NEM to target the food and beverage industry, including beverages and beverage bases, fruit and vegetable juices, baked goods, soft candy and snack foods.  The Allowable Daily Intake (ADI) for NEM, which contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues, is up to 14 grams per day for food use and intake. 

Previously published clinical research showed NEM improves joint comfort and flexibility in just seven to 10 days at a dose of only 500mg per day.  "It is, therefore important to demonstrate to the public the safety of this product for use in either dietary supplements or food products that are expected to be consumed on a continuing basis," Ruff noted.