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Dietary supplement firm signs consent decree with FDA to stop selling product containing ephedrine hydrochloride
On October 30, 2001, at the request of the FDA, US Marshals seized $2.8 million worth of E'OLA's product, known as AMP II Pro Drops. Previous FDA inspections found that the products contain a drug, ephedrine hydrochloride, but are labeled as a dietary supplement for use in weight loss. These E'OLA products violate the law because drug ingredients are prohibited for use in dietary supplements.
Ephedrine hydrochloride has been approved as a drug by FDA since 1948, and therefore cannot be legally marketed as a dietary supplement. E'OLA also marketed its product as a treatment for obesity. Products marketed to treat diseases are drugs. The product is also misbranded because its labeling fails to bear adequate directions for its intended use.
The Food and Drug Administration today announced that Biogenics Inc., of St. George, Utah, doing business as E'OLA International, has signed a consent decree that prohibits the firm from manufacturing and distributing violative products. These include AMP II Pro Drops, any product containing ephedrine hydrochloride, or any synthetic ephedrine alkaloid, or any drug product that is a new drug not approved by FDA.
The decree also gives FDA the authority to order the firm to discontinue the marketing of and recall any products that violate the law in the future. The decree was signed Friday, April 12, 2002, by United States District Court Judge Tena Campbell in Salt Lake City, Utah. "This action is yet another example of FDA's strong commitment to protecting the public from the dangers of unlawfully marketed drug products," said Lester M. Crawford, D.V.M., Ph.D., Deputy Commissioner of The Food and Drug Administration.
As a result of this consent decree, E'OLA International will destroy the seized articles at its own expense under the supervision of a Department of Health and Human Services representative within 25 days.
On October 30, 2001, at the request of the FDA, US Marshals seized $2.8 million worth of E'OLA's product, known as AMP II Pro Drops. Previous FDA inspections found that the products contain a drug, ephedrine hydrochloride, but are labeled as a dietary supplement for use in weight loss. These E'OLA products violate the law because drug ingredients are prohibited for use in dietary supplements.
Ephedrine hydrochloride has been approved as a drug by FDA since 1948, and therefore cannot be legally marketed as a dietary supplement. E'OLA also marketed its product as a treatment for obesity. Products marketed to treat diseases are drugs. The product is also misbranded because its labeling fails to bear adequate directions for its intended use.
The Food and Drug Administration today announced that Biogenics Inc., of St. George, Utah, doing business as E'OLA International, has signed a consent decree that prohibits the firm from manufacturing and distributing violative products. These include AMP II Pro Drops, any product containing ephedrine hydrochloride, or any synthetic ephedrine alkaloid, or any drug product that is a new drug not approved by FDA.
The decree also gives FDA the authority to order the firm to discontinue the marketing of and recall any products that violate the law in the future. The decree was signed Friday, April 12, 2002, by United States District Court Judge Tena Campbell in Salt Lake City, Utah. "This action is yet another example of FDA's strong commitment to protecting the public from the dangers of unlawfully marketed drug products," said Lester M. Crawford, D.V.M., Ph.D., Deputy Commissioner of The Food and Drug Administration.
As a result of this consent decree, E'OLA International will destroy the seized articles at its own expense under the supervision of a Department of Health and Human Services representative within 25 days.