August 7, 2013

By Paul Faganel, President, Embria Health Sciences

Recently, there have been articles in the news about some dietary supplement companies producing unsafe or unapproved products. That’s why it’s so important to remind our customers and consumers that Embria Health Sciences goes above and beyond to ensure the safety of EpiCor®, Embria’s immune strengthening ingredient. Consumer safety is our first priority.We meet and exceed ALL rules and regulations concerning product safety and manufacturing. Our facilities also adhere to all standards for product and employee safety.

Embria is a U.S.-based food grade manufacturer certified by NSF International (NSF) to meet all the strict standards for current Good Manufacturing Practices (cGMP). What is cGMP? cGMP refers to the Current Good Manufacturing Practice regulations enforced by the US Food and Drug Administration (FDA).  cGMPs provide standards for systems to assure proper design, monitoring and control of manufacturing processes and facilities. NSF certification requires regular on-site inspections of our manufacturing facilities to ensure we meet the current safety standards under cGMP regulations.

As well as being NSF cGMP certified, Embria’s manufacturing facility was inspected by the FDA. As expected, it was a short audit since there were no concerns raised.

Not only does our manufacturing facilities meet or exceed the strictest standards, EpiCor has been thoroughly researched for safety, including multiple published human clinical studies and a dedicated safety study published in the International Journal of Toxicology Because of our strong safety science and history of safe use, Embria has successfully submitted a New Dietary Ingredient (NDI) Notification to the FDA to document the safety of EpiCor®.Under the Dietary Supplement Health and Education Act of 1994, NDI’s are required for all dietary supplement ingredients not marketed in the United States before October 15, 1994.

EpiCor not only meets dietary supplement safety standards, an independent panel of food safety experts concluded EpiCor meets FDA requirements to be considered Generally Recognized as Safe (GRAS) for conventional, everyday foods.

Testing by NSF also confirms that EpiCor does not contain substances banned from athlete use.  The NSF Prohibited Substances List contains ingredients identified by leading sports organizations, such as the World Anti-Doping Agency (WADA), the National Football League (NFL) and Major League Baseball (MLB).

I welcome customers, consumers, and the media to make inquiries about Embria’s policies, registrations, accreditations and investments in the area of product safety.

Thank you,

Paul Faganel

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