12 Dangerous Dietary Supplements Named by Consumer Reports

April 1, 2004 -- Consumer Reports, in the May issue, says they have found 12 dietary supplements that are too dangerous to be on the market according to government warnings, adverse-event reports, and top experts. These "dirty dozen" unsafe supplements, which CR easily purchased in stores and online in February, include:

-- Aristolochia: A herb conclusively linked to kidney failure and cancer.

-- Yohimbe: A sexual stimulant linked to heart and respiratory problems.

-- Bitter orange: Its ingredients have effects similar to the banned weight-loss supplement ephedra.

-- Chaparral, comfrey, germander, and kava: All known or likely causes of liver failure.

(see chart below of all of the targeted supplements)

The potentially dangerous effects of most of these products have been known for more than a decade, and at least five of them are banned in Asia, Europe, or Canada. Yet until very recently, the U.S. Food and Drug Administration had not managed to remove a single dietary supplement from the market for safety reasons. After seven years of trying, the agency announced a ban on the weight-loss aid ephedra in December 2003.

In March 2004 it warned 23 companies to stop marketing the body-building supplement androstenedione (andro). Despite these actions against high-profile supplements, whose dangers were so well- known that even industry stopped defending them, the agency continues to be hamstrung by the 1994 Dietary Supplement Health and Education Act (DSHEA).

While prescription and over-the-counter drug manufacturers are required to prove that their products are safe before being marketed, DSHEA makes the FDA prove that supplements on the market are unsafe and denies the agency all but the sketchiest information about the safety record of most of them. Major differences in the safety regulations of prescription and over-the-counter drugs vs. dietary supplements are outlined in the attached fact sheet.

There are signs of hope. The FDA has said that if the ban on ephedra holds up against likely legal challenges, it plans to go after other harmful supplements. Two bills, introduced by Senator Richard Durbin and Representative Susan Davis, would strengthen the FDA's authority under DSHEA. Consumers Union, the independent, nonprofit publisher of Consumer Reports, supports this legislation. Though these bills are still in committee, the supplement industry has mobilized in opposition.

Many people wrongly believe that the federal government regulates supplements. Until the law is substantially changed, consumers cannot rely on the federal government to ensure that dietary supplements are safe and effective.

Here are some steps consumers can take to minimize risk:

-- Stay away from the dirty dozen. All carry risks that in CR's view are unacceptable.

-- Do not take daily doses of vitamins and minerals that exceed the safe upper limits. While vitamins and minerals are the safest and best-studied of supplements, it's possible to overdose on some of them. For more information visit http://www.ific.org/publications/other/driupdateom.cfm.

-- Limit your intake of other supplements. CR's experts have identified a few products with possible benefits and sufficiently low risks to recommend for general use: saw palmetto for benign enlarged prostate in men, glucosamine and chondroitin for arthritis, and fish oil capsules for heart disease.

-- Tell your doctor about your supplements. Some supplements may reduce the effectiveness of prescription drugs.

-- Stay away from supplements for weight control. These products frequently contain stimulants that have never been adequately tested separately, let alone in combination.

-- Do your own research. Even physicians are not necessarily knowledgeable about the scientific evidence regarding dietary supplements. Reliable information can be found on the web sites of the National Institutes of Health and Memorial Sloan-Kettering Cancer Center.

-- Watch for adverse events. Let your doctor know if you are experiencing anything worrisome after starting a supplement.

-- Visit ConsumersUnion.org to learn more about dietary supplements.

"Dangerous Supplements Still At Large" is available free now at http://www.ConsumerReports.org/co/supplements.

The May 2004 issue of CR will be available in bookstores April 12. To subscribe, call 800-765-1845.

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