A dietary supplements company has filed a federal lawsuit challenging the Food and Drug Administration’s ban on supplements containing ephedra.
The supplements were widely used for weight loss and bodybuilding, but have linked to 155 deaths, including that of Baltimore Orioles pitcher Steve Bechler. The FDA’s ban on all dietary supplements containing ephedra went into effect April 12.
Nutraceutical Corp. and its subsidiary Solaray claim in their lawsuit, filed Monday, that ephedra “has been safely consumed for millennia.”
The company contends its product is safe because it contains only low doses of the ephedrine alkaloid. Ephedra contains two alkaloids, ephedrine and pseudoephedrine.
Lawsuit seeks reversal of ban or compensation
The lawsuit claims that the FDA did not meet its burden of proving that all ephedrine dietary supplements present “a significant or unreasonable risk of illness or injury at every dose level and as labeled.”
The suit seeks to have the FDA’s rule declared illegal. It asks that if the court does not find the rule to be illegal, then it rule that Nutraceutical’s loss be considered a “taking,” which would require the government to pay compensation.
Research shows the herb can speed heart rate and constrict blood vessels even in seemingly healthy people, but it’s particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise.
Ephedra is a plant with varieties growing in Asia, Australia, Europe and North America. In China, it has been used for 4,000 years to treat respiratory infections. A wild variety in the U.S. Southwest was used medicinally by early settlers. Typically, the whole plant is powdered and used in pills or other preparations.
The FDA has argued that it amassed sufficient proof of ephedra’s dangers from thousands of side-effect reports and scientific studies that proved the herb’s stimulant-like effects inside the body.
A federal judge in New Jersey refused to block the ban in a similar case brought by other dietary supplement companies. That ruling, which rejected a request for a temporary restraining order, was issued the day the federal ban took effect.