Supplement Safety An Iffy Proposition

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.

Sweet trouble

Nobody wants to choke down a yucky supplement, but pills that look or taste like candy may be hazardous to a child's health. Some nutrients are troublesome — or even deadly — in high doses (see Chapters 10 and 11), especially for kids. For example, the Food and Drug Administration warns the lethal dose for young children may be as low as 3 grams (3,000 milligrams)

elemental iron, the amount in 49 tablets with 65 milligrams iron apiece. If you have youngsters in your house, protect them by buying neutral-tasting supplements and keeping all pills, nutrient and otherwise, in a safe cabinet, preferably high off the floor and locked tight to resist tiny prying fingers.

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 i Require premarket tests to prove that supplements are safe and effective i Limit the dosage in any dietary supplement i 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.

By the way, ephedra isn't the only herbal supplement that can make you really uncomfortable. Table 5-1 lists some equally problematic herbal products that you need to approach with caution — or avoid altogether. In many cases, even small amounts are hazardous.

Table 5-1 Some Potentially Hazardous Herbals

Herb

Known Side Effects and Reactions

Blue cohosh

Nausea, vomiting, dizziness, smooth

muscle (such as the uterus) contractions

Chaparral

Liver damage, liver failure

Comfrey

Possible liver damage

Kombuchu tea

Potentially fatal liver damage, intestinal

upset

Lobelia (Indian tobacco)

Potentially fatal convulsions, coma

Pennyroyal

Potentially fatal liver damage, convulsions,

coma

Senna

Severe gastric irritation, diarrhea

Stephania (also known as magnolia)

Kidney damage (sometimes severe enough

to require dialysis or transplant)

Valerian

Severe withdrawal symptoms

"Vitamin and nutritional supplements," Mayo Clinic Health Letter (supplement), June 1997; Nancy Beth Jackson, "Doctors' warning: Beware of herbs' side effects," The New York Times, November 18, 1998; Jane Brody, "Taking a gamble on herbs as medicine," The New York Times, February 9, 1999; Carol Ann Rinzler, The Complete Book of Herbs, Spices, and Condiments (New York: Facts on File, 1990)

"Vitamin and nutritional supplements," Mayo Clinic Health Letter (supplement), June 1997; Nancy Beth Jackson, "Doctors' warning: Beware of herbs' side effects," The New York Times, November 18, 1998; Jane Brody, "Taking a gamble on herbs as medicine," The New York Times, February 9, 1999; Carol Ann Rinzler, The Complete Book of Herbs, Spices, and Condiments (New York: Facts on File, 1990)

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