Safety Evaluation of ESM Technologies’ NEM® Published in Food and Chemical Toxicology

ESM Technologies, the leading supplier of innovative, commercialized eggshell and eggshell membrane wellness ingredients, is excited to announce the publication of a safety manuscript for their flagship eggshell membrane ingredient NEM®.  The manuscript entitled “Safety evaluation of a natural eggshell membrane-derived product” has been published online ahead of print in the journal Food and Chemical Toxicology (http://dx.doi.org/10.1016/j.fct.2011.12.036).  This research evaluated NEM’s safety via multiple in vitro and in vivo toxicological studies.

The NEM® safety and toxicology studies were conducted by a variety of independent research labs.  NEM® was evaluated 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.  NEM® did not show any signs of toxicity in any of the areas that were evaluated.  These results demonstrate that NEM® is extremely 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., MBA, ESM Technologies’ Director of Scientific & Regulatory Affairs.

This safety evaluation formed the basis for an independent expert panel to deem NEM® Generally Recognized As Safe (GRAS), allowing NEM® to expand into the food and beverage industry.  There are numerous food and beverage categories for which NEM® is approved for use; a few include beverages and beverage bases, fruit and vegetable juices, baked goods, soft candy and snack foods.  The Allowable Daily Intake (ADI) for NEM® is up to 14 grams per day for food use and intake.

NEM® contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues.  Previous published clinical research on NEM® showed an improvement in joint comfort and flexibility in just 7 to 10 days with only 500mg per day.  Dr. Ruff states, “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.”

ABSTRACT:

NEM® is a novel dietary ingredient that contains naturally occurring glycosaminoglycans and proteins essential for maintaining healthy joint and connective tissues. NEM® was evaluated for safety via in vitro and in vivo toxicological studies. This included testing for cytotoxicity, genotoxicity, acute oral toxicity, and 90-day repeated-dose oral toxicity. NEM® did not exhibit any cytotoxic effects at a dose of 100 μg in an in vitro human cell viability assay after incubation for up to 20 h. NEM® did not exhibit any genotoxic effects in an in vitro assay of four strains of histidine-dependent Salmonella typhimurium and one strain of tryptophan-dependent Escherichia coli at a dose of up to 5000 μg/plate. NEM® did not exhibit any signs of acute toxicity in rats at a single oral dose of up to 2000 mg/kg body weight, nor signs of toxicity (via urinalysis, hematology, clinical chemistry, or histopathological evaluation) in rats at a repeated oral dose of up to 2000 mg/kg body weight per day for 90 days. The results of these studies suggest that NEM® may be safe for human consumption.

*These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.
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