The Food and Drug Administration (FDA) regulates food and drugs (no surprise there). Before the agency allows a new food or a new drug on the market, the manufacturer must submit proof that the product is safe. Drug manufacturers must also meet a second test, showing that their new medicine is efficacious, a fancy way of saying that the drug and the dosage in which it’s sold will cure or relieve the condition for which it’s prescribed. Nobody says the drug-regulation system’s perfect. Reality dictates that manufacturers test a drug only on a limited number of people for a limited period of time.
So you can bet that some new drugs will trigger unexpected, serious, maybe even life-threatening side effects when used by thousands of people or taken for longer than the testing period. For proof, look no further than Phen-Fen, a diet drug combination that appeared to control weight safely during premarket testing but turned lethal after it reached pharmacy shelves. But at least the FDA can require that premarket safety and/or effectiveness info be displayed on foods and drugs. Unfortunately, the agency has no such power when it comes to dietary supplements.
In 1994, Congress passed and President Clinton signed into law the Dietary Supplement Health and Education Act, which limits the FDA’s control over dietary supplements. Under this law, The FDA can’t
So you can bet that some new drugs will trigger unexpected, serious, maybe even life-threatening side effects when used by thousands of people or taken for longer than the testing period. For proof, look no further than Phen-Fen, a diet drug combination that appeared to control weight safely during premarket testing but turned lethal after it reached pharmacy shelves. But at least the FDA can require that premarket safety and/or effectiveness info be displayed on foods and drugs. Unfortunately, the agency has no such power when it comes to dietary supplements.
In 1994, Congress passed and President Clinton signed into law the Dietary Supplement Health and Education Act, which limits the FDA’s control over dietary supplements. Under this law, The FDA can’t
- Require premarket tests to prove that supplements are safe and effective
- Limit the dosage in any dietary supplement
- Halt or restrict sales of a dietary supplement unless evidence shows that the product has caused illness or injury when used according to the directions on the package; in other words, if you experience a problem after taking slightly more or less of a supplement than directed on the label, the FDA can’t help you.
As a result, the FDA has found it virtually impossible to take products off drugstore shelves even after reports of illness and injury. For example, supplements containing the herb ephedra are reputed to enhance weight loss and sports performance. More than 600 reports of illness and at least 100 deaths have been linked to the use of ephedra supplements. The herb is banned by professional football and college athletics in the U.S. and by the Olympics. However, the FDA didn’t act until February 2003, following the death of Baltimore Orioles pitcher Steve Bechler, who reportedly had been using ephedra products to control his weight.
Bechler’s untimely death rang warning bells across the country, including in Washington, D.C., where the FDA ruled that henceforth every bottle of ephedra must carry strong warnings that the popular herb can cause potentially lethal heart attacks or strokes. In the sports world, ephedra was immediately forbidden in minor league but not major league baseball. The FDA banned all ephedra products, but the ban was partially reversed in April 2005, when a federal judge ruled that products containing low doses of ephedra were safe and could remain on the market. Some in Congress are pressing for a law that would enable FDA to ban any supplements considered even potentially hazardous to your precious health. Stay tuned.
Bechler’s untimely death rang warning bells across the country, including in Washington, D.C., where the FDA ruled that henceforth every bottle of ephedra must carry strong warnings that the popular herb can cause potentially lethal heart attacks or strokes. In the sports world, ephedra was immediately forbidden in minor league but not major league baseball. The FDA banned all ephedra products, but the ban was partially reversed in April 2005, when a federal judge ruled that products containing low doses of ephedra were safe and could remain on the market. Some in Congress are pressing for a law that would enable FDA to ban any supplements considered even potentially hazardous to your precious health. Stay tuned.
No comments:
Post a Comment