Federal judge Tena Campbell has ruled against United States’ Food and Drug Administration’s (FDA) ban on ephedra in a weight-loss supplement believed to be associated with 155 deaths. The ruling, however, doesn’t indicate that the supplement would return to shelves after being banned for a year.
Agreeing with Nutraceutical’s contention that the ephedra supplement should be considered ‘food’ and not a ‘drug’, Judge Campbell said a 1994 federal dietary supplement law enforces greater restrictions on the FDA for banning foods as compared to drugs. According to Campbell, under this law, the FDA would have to prove that a dietary supplement might pose health complications. In case of drugs, the maker has to prove that the drug is safe for prescription. “The statement that a safe level cannot be determined is simply not sufficient to meet the government’s burden,” Campbell said.
Ephedra, used by Nutraceutical in a supplement, has been shown to increase heart rate speed and also cause constriction in the blood vessels of healthy people. So those who suffer from heart ailments or high blood pressure are especially susceptible to fatalities induced by the supplement.
The case has now been sent back to FDA for further tests and approval and till then, Nutraceutical cannot sell the supplement.
Meanwhile, FDA is evaluating the judge’s decision. However, William Pierce of the Health and Human Services said the FDA had ‘made the right decision from the standpoint of science and our statutory authority’. “This is exactly when the dietary supplement law should apply,” he said.
According to Nutraceutical’s president Bruce Hough, the case had more to do with persuading the FDA to observe legal guidelines than about returning ephedra supplements to the shelves.
