FDA seizes more ephedra supplements

On the request of the FDA, the US Attorney's Office for the Northern District of Georgia filed a complaint for Forfeiture against Lipodrene, Stimerex-ES and Betadrene dietary supplements, manufactured by Hi-tech Pharmaceuticals.

With the legal position of ephedra-containing products still unclear, the FDA said it continues to warn consumers to avoid consuming such products.

"We will continue to do all we can to protect the public health against these dietary supplements that have been found to cause serious illness and injury,"​ said Andrew von Eschenbach, acting FDA commissioner.

Ephedra has been marketed as a supplement for weight-loss and sports performance, but a number of recent studies have linked ephedrine alkaloids with adverse effects on the cardiovascular and central nervous systems.

And in February 2004 the FDA issued a rule declaring that dietary supplements containing ephedrine alkaloids present an "unreasonable risk of illness or injury." Since this rule became effective in April 2004, the government has executed six seizures against numerous products.

Last week's seizure from Hi-Tech Pharmaceutical's facilities in Norcross, Georgia, included more than 200 cases of finished product, more than 200 boxes of bulk tablets and nine 25 kilo drums of ephedrine alkaloid raw material.

According to the FDA, the supplements in question are labeled as containing 25mg of ephedrine alkaloids per tablet. The product labels also state that the maximum recommended dosage of ephedrine for a healthy adult is 100 mg in a 24 hour period. But in the United States, dietary supplements containing more than 10mg of ephedrine alkaloids are outlawed.

However, in April 2005, a Utah judge ruled that the FDA failed to prove that a daily dosage of 10mg or less of ephedra presents an unreasonable risk of illness or injury.

Judge Teena Campbell ordered the FDA to carry out a dose-dependent toxicology study and impose a ban on the herbal's use only at and above the level at which it is found to produce toxicity. She also enjoined the government agency from taking any enforcement action to block Nutraceutical Corp, which brought the action, from selling supplements containing 10mg or less of ephedrine alkaloids per daily dose.

And H-Tech previously filed a lawsuit against FDA seeking to prevent the agency from enforcing the 2004 rule declaring dietary supplements containing ephedrine alkaloids to be adulterated. The United States recently moved to dismiss that lawsuit, which is currently pending in the United States District Court for the Northern District of Georgia.

Some lawmakers believe that the dietary supplements industry should be subject to the same regulations as pharmaceutical drugs. But the industry associations have frequently and vociferously defended the 1994 Dietary Supplement Health and Education Act as a good law.

A report carried out by the RAND Corporation prior to the initial ban suggested that it could have potentially dangerous effects on the heart. Other studies have also indicated that ephedra use raises blood pressure and otherwise stresses the circulatory system, which could lead to heart disease and stroke.

The FDA has said that there is little evidence for the herbal's effectiveness other than for short-term weight loss.

United States Attorney David Nahmias commented on last week's enforcement action that "the FDA has advised that these dietary supplements can be dangerous to the health of the citizens in our communities. This office and the FDA are taking the legal steps to safeguard the health and safety of people who may not know or understand the dangers that they face using ephedrine alkaloid products."​