Federal Judge Removes FDA Ban on Lower Doses of Ephedra
U.S. District Judge Tena Campbell on Thursday removed the FDA ban on dietary supplements that contain lower doses of ephedra because the agency did not have adequate evidence to prove the safety risks of such products, the Salt Lake Tribune reports. The case involves a lawsuit filed against FDA by Nutraceutical, which had manufactured dietary supplements that contain ephedra (Warchol, Salt Lake Tribune, 4/15).
FDA in February 2004 banned the sale of products that contain ephedra. FDA has linked ephedra -- often used for weight loss and athletic performance enhancement -- to about 16,000 adverse events -- such as heart attacks, irregular heartbeats and strokes -- and 155 deaths. FDA classifies dietary supplements as food and does not require them to meet the same requirements as prescription drugs. Under the 1994 Dietary Supplements Health and Education Act, dietary supplements can enter the market without FDA approval, and manufacturers are not required to inform the agency of any adverse effects that are associated with supplements (California Healthline, 4/13/04).
In the decision, Campbell wrote, "The FDA must prove that any dose amount, no matter how small, presents a significant or unreasonable risk of illness or injury." She added, "The proper focus here is on the evidence the FDA presented regarding the risk" of dietary supplements that contain lower doses of ephedra, and the agency failed to prove such a risk (Bloomberg/Richmond Times Dispatch, 4/15). In addition, Campbell wrote that FDA has improperly regulated ephedra as a medication, rather than a food (Thiessen, Washington Post, 4/15).
"The plain language of" the 1994 law "does not require a comparison of benefits and risks" of dietary supplements, according to Campbell (Wilde Mathews/Schaefer Munoz, Wall Street Journal, 4/15). The FDA statement that a "safe level" of ephedra "cannot be determined is simply not sufficient to meet the government's burden," she wrote. Under the decision, FDA cannot ban the sale of dietary supplements that contain less than 10 milligrams of ephedra (Washington Post, 4/15). Campbell returned the issue to FDA "for further rulemaking consistent with the court's opinion" (Weise, USA Today, 4/15). "It is unknown" whether FDA will appeal the decision, the Tribune reports (Salt Lake Tribune, 4/15).
According to the Wall Street Journal, the decision likely will "spark new debate over how dietary supplements are regulated at a time when the products are a focus of renewed concern" (Wall Street Journal, 4/15). Sen. Richard Durbin (D-Ill.) said that the decision highlighted a need for a "mandatory and uniform system of reporting adverse health events that result from the use of certain dietary supplements" (Washington Post, 4/15).
Rep. Henry Waxman (D-Calif.) said, "I hope and expect that FDA's ban will be upheld on appeal. If it is not, it will clearly be time for Congress (to) give FDA the authority it needs to protect American consumers from dangerous supplements" (Bell, Baltimore Sun, 4/15).
Sen. Orrin Hatch (R-Utah), who wrote the 1994 law, said, "I do not believe it is a good example of how the government should resolve dietary supplement safety. No one -- not the FDA, the supplement industry, nor the public -- has been satisfied by how ephedra has been regulated. Millions of people have used the product with satisfaction, but there is no doubt the product has had some serious problems" (Salt Lake Tribune, 4/15).
FDA spokesperson Kim Rawlings said, "The FDA interprets this to mean that the order remains in effect as to higher doses of these products and that it applies to the plaintiff's products. FDA is considering all its options with respect to the next step it will take" (Baltimore Sun, 4/15).
Steven Mister, president and CEO of the Council for Responsible Nutrition, said that the decision "applied only to a very specific segment of the ephedra dietary supplement market and should not be misinterpreted as a complete overturn of the ephedra ban, nor should anyone leap to inappropriate conclusions about what this means" (Bloomberg/Richmond Times Dispatch, 4/15).
Sidney Wolfe, director of the Health Research Group at Public Citizen, said, "The idea that when you're below a certain dose of ephedra is safe is a ridiculous idea. That a court would arrive at a decision like this is reason enough for Congress to repeal the dietary-supplements law" (Salt Lake Tribune, 4/15).
Julian Bailes, chair of neurosurgery at West Virginia School of Medicine, called the decision "a green light to abuse this substance again" (Harris, New York Times, 4/15).
However, Nutraceutical President Bruce Hough said the company had no plans to return products that contain ephedra to market. "This was not filed because of our desire to sell ephedra, but because FDA set a standard that would have long-term ramifications for many products sold within the nutritional supplement industry" (USA Today, 4/15).