E'OLA Signs FDA Consent Decree

ST. GEORGE, Utah--Biogenics Inc. dba E'OLA International signed a consent decree with the Food and Drug Administration (FDA) prohibiting the company from manufacturing or distributing any products that violate FDA regulations. The decree stems from an October 2001 seizure of products containing ephedrine hydrochloride (HCl) that were labeled as dietary supplements for obesity.

Under terms of the agreement, Biogenics may not market any products containing ephdedrine HCl, or any synthetic ephedrine alkaloid, or any unapproved drug product. Also, the company must destroy, at its own expense, the 140,000 bottles of AMP II Pro Drops that were seized by U.S. marshals in October.

In a statement issued by E'OLA, the company noted it negotiated in good faith with the agency to adopt an equitable agreement. "We are pleased to finally have this issue behind us and to get back to business," said Fred Rogers, manager of legal affairs for E'OLA International (www.eola.com). "E'OLA has many fine products that are as effective as those we have phased out. We tried for years to get the FDA to give us clear direction regarding our ingredients and products. We had every desire to cooperate with the agency, but had no success in getting definitive answers. That leads us to believe that the seizure action was more about headlines than about resolving issues. That is frustrating."

"But now that is in the past. E'OLA is proud of its extensive line of high quality, natural ephedrine-based products that we will continue to produce and market for our thousands of loyal customers and distributors."