Embria Health Sciences, manufacturer of the immune support dietary supplement ingredient EpiCor, stated it is confident EpiCor was not part of the U.S. Health and Human Service’s Office of Inspector General (OIG) investigation of immune and dietary supplement products. The findings of that investigation, announced this week, claimed that 20 percent of the supplement products investigated made false or misleading disease claims or were not properly substantiated.
“We believe EpiCor was not reviewed against FDA's Guidance regarding structure/function claims,” said Kevin Boot, Embria regulatory counsel. “If OIG had examined EpiCor's substantiation, Embria firmly believes OIG would agree EpiCor's substantiation meets FDA requirements for supporting the
structure/function claims Embria suggests to its customers.”
“The totality of EpiCor’s clinical studies fully supports every claim suggested by Embria. There are no studies to contradict EpiCor’s immune health claims,” said Boot. “Every EpiCor claim is based on studies that are randomized, double-blind, parallel group, placebo-controlled trials with substantive populations and published in respected journals. This is in clear contrast to the research of the products investigated by the OIG.”
Embria stated the company is disappointed that OIG did not release product and company names because it would have helped consumers sort out the good, like EpiCor, from the not-so-good immune products.