In what it is calling a victory for consumer protection, the US Food & Drug Administration (FDA) has forced Utah-based company Biogenics to agree to stop making products containing drugs but sold as dietary supplements.
Biogenics, which trades as E'OLA International, has signed a consent decree that prohibits it from making products such as AMP II Pro Drops, any product containing ephedrine hydrochloride or any synthetic ephedrine alkaloid, and also any drug product that is not approved by the FDA.
The decree follows a raid on Biogenics' headquarters last October which resulted in the seizure of $2.8 million (€3.2m) worth of E'OLA's products, known as AMP II Pro Drops. Earlier inspections by the FDA had revealed that these products -labelled as dietary supplements for weight loss - contravene US regulations because they contain a drug, ephedrine hydrochloride. 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, but under FDA rules products marketed to treat diseases are also classified as drugs.
Ephedrine is the chemical form of the popular herbal remedy ephedra, and the FDA's action is seen as a clear indication that it will not allow companies to sell ephedrine products masquerading as ephedra.
John Taylor, the FDA's enforcement officer, said: "People have masqueraded behind the claim that their product was a pure ma huang [ephedra] product. It's a signal that we are concerned about products that are promoted as dietary supplements that are actually unlawfully marketed drug products."
The FDA said that E'OLA had also broken the law because the labelling of its AMP II Pro Drops did not give adequate directions for its intended use.
E'OLA now has 25 days to destroy all the items seized by the FDA.