Editor's note: Soon after Ohio University students return from spring break, the commonly used dietary supplement ephedra will be illegal. As investigations continue into the use of steroids and other performance enhancers in sports such as baseball, the ban on ephedra marks the first time a dietary supplement has been restricted. The Post has taken an in-depth look at ephedra: its effects, the FDA's battle to ban it and why students and athletes use the product. This is the first in a five-day series.
On April 12, the Food and Drug Administration can take legal action against manufacturers and distributors of the weight-loss aid ephedra if they continue the sale and distribution of products containing the supplement.
The new law stems from a final ruling by the FDA on Feb. 11, prohibiting the sale of dietary supplements containing ephedra because the supplement presents an unreasonable risk of illness or injury, according to an FDA spokeswoman.
According to the FDA, about 155 deaths can be linked to ephedra, and this is the first time U.S. officials have blocked the sale of an over-the-counter nutritional supplement.
Ephedra-based supplements that promise to increase the quality of sport performance are being especially targeted, and most have been removed from stores.
The rule does not pertain to traditional Chinese herbal remedies or to products like herbal teas that are regulated as conventional foods.
The FDA first proposed regulating ephedra in 1997 but had not developed sufficient evidence to take action.
Under the Federal Food, Drug and Cosmetic Act and the FDA's regulations, the labeling requirements of dietary supplements have changed.
Labels now must include: the product's name identifying it as a dietary supplement, a supplement facts panel containing nutritional information, a list of any additional ingredients not listed in the panel, the name and address of the manufacturer, packer, or distributor and the net quantity of contents.
Also, if the labeling makes a claim that the product affects functions of the body, mood, or helps fight disease, the product must also include a disclaimer stating that the FDA has not evaluated the claim and the product is not intended to diagnose, treat, cure or prevent any disease.
This is an important distinction because unlike drugs, dietary supplements do not have to get prior approval from the FDA.
The law requires us to go through ... a scientific finding. When a pharmaceutical company wants to put a drug on the market
they have to prove its efficacy and safety but nutrition and supplement drugs don't have to go through that process said Health and Human Services Secretary Tommy Thompson at a press conference on Dec. 30, 2003.
The ruling came after months of scientific analysis by the FDA, which studied more than 16,000 adverse incidents reports.
Ephedra, also known as Ma huang, has been marketed as a weight-loss aid and is known for boosting sports performance. The data showed little support for these claims, except for short-term weight loss, and confirmed that ephedra raises blood pressure and stresses the circulatory system. These effects are linked to heart attacks and strokes as seen in the case of Baltimore Orioles pitcher Steve Bechler, who died of heat stroke in February 2003.
Ephedra's history in sports:
-1993: The International Olympic Committee banned ephedra.
-1997: The NCAA added ephedra to its list of banned substances in 1997 and began year-round drug testing for the supplement in 2002.
-Sept. 8, 2001: The National Football League became the first profes- sional sports league to ban ephedra. The ban came one month and seven days after the death of Minnesota Viking's lineman Korey Stringer during training camp. A bottle of Ripped Fuel
which con- tains ephedra, was found in Stringer's locker, and some believe the supplement might have contributed to his death.
-July 2002: Former Vikings and current Washington Redskins tight end Byron Chamberlain tested positive for the drug before the start of the season and was suspended by the league for four games, costing him an estimated $176,470 in lost pay.
-Feb. 17, 2003: Baltimore Orioles' pitcher Steve Bechler collapsed dur- ing a workout because of complications of heat stroke. Bechler also had been using ephedra. The player's union has allowed baseball to ban ephedra in its minor leagues but has resisted a ban at the pro level.
-October 2003: The National Basketball Association, which banned ephedra before the opening of its 2001-2002 season, started to test for the drug in 2003.
-Jan. 6, 2004: NASCAR added ephedra to its list of banned substances.
-The National Hockey League has yet to ban the supplement and has never tested its players for steroids or illegal drugs.
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Megan Cotten
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Students walk past the Iron Empire, 42 S. Court St., one of the last stores in Athens to carry the newly banned dietary supplement ephedra.
