April 1, 2004 -- Despite known hazards, many potentially dangerous dietary supplements are readily available for purchase in stores and on the Internet, according to a new report from Consumer Reports.

Today, the magazine released its "dirty dozen" list of dietary supplements that it says are too dangerous to be on the market.

The list includes yohimbe, bitter orange, chaparral, and andro. But researchers say the supplements are sold under many names, which makes it hard for consumers to know what they're getting.

Many of the supplements that made the list have already been banned in other countries. But researchers say regulatory barriers created by Congress have prevented the FDA from taking similar actions to protect consumers in this country.

The announcement coincides with a report on supplement safety issued today by the Institute of Medicine, which suggests that the FDA should take action against potentially hazardous dietary supplements and asks Congress to ease restraints on the agency.

Dirty Dozen of Dietary Supplements

Researchers from the consumer magazine say the supplements that made its "dirty dozen" list may cause cancer, severe liver or kidney damage, heart problems, or even death.

For example, they say the herb aristolochia has been conclusively linked to kidney failure and cancer in China, Europe, Japan, and the U.S. Yohimbe, a supplement marketed as a sexual stimulant and herbal Viagra, has been linked to heart and respiratory problems. The supplement bitter orange, whose ingredients have effects similar to those of the banned weight-loss stimulant ephedra, is also on the list of potentially dangerous supplements.

Many of these dietary supplements are sold in both single and combination products marketed for a wide variety of uses, from building muscle and losing weight to easing stress and arthritis.

Researchers divided the list into three categories based on the amount of available evidence about the dietary supplement: definitely hazardous, very likely hazardous, and likely hazardous.
 

Since the brand names of the products containing the dirty dozen supplement ingredients vary widely, researchers say consumers should read ingredient labels carefully and look for the following:

Definitely Hazardous

• Aristolochic acid (Aristolochia, birthwort, snakeroot, snakeweed, snagree root, sangrel, serpentary, wild ginger).They list this as having caused documented human cancers, and it is linked to kidney failure.

Very Likely Hazardous -- These are banned in other countries, have an FDA warning, or show adverse effects in studies:

• Comfrey (Symphytum officinale, ass ear, black root, blackwort, bruisewort, consolidae radix, consound, gum plant, healing herb, knitback, knitbone, salsify, slippery root, symphytum radix, wallwort). Abnormal liver function or damage, often irreversible; deaths reported.

• Androstenedione (4-androstene-3, 17-dione, andro, androstene). Increased cancer risks and decreases in "good" HDL cholesterol have been reported.

• Chaparral (Larrea divaricata, creosote bush, greasewood, hediondilla, jarilla, larreastat). Abnormal liver function has been linked to use.

• Germander (Teucrium chamaedrys, wall germander, wild germander). Abnormal liver function has been linked to use.

• Kava (Piper methysticum, ava, awa, gea, gi, intoxicating pepper, kao, kavain, kawa-pfeffer, kew, long pepper, malohu, maluk, meruk, milik, rauschpfeffer, sakau, tonga, wurzelstock, yagona, yangona). Abnormal liver function has been linked to use.

Likely Hazardous -- These have adverse-event reports or theoretical risks.

• Bitter orange (Citrus aurantium, green orange, kijitsu, neroli oil, Seville orange, shangzhou zhiqiao, sour orange, zhi oiao, zhi xhi). High blood pressure; increased risk of heart arrhythmias, heart attack, and stroke are risks associated with use.

• Organ/glandular extracts (brain/adrenal/pituitary/placenta/other gland "substance" or "concentrate"). Theoretical risk of mad cow disease, particularly from brain extracts.

• Lobelia (Lobelia inflata, asthma weed, bladderpod, emetic herb, gagroot, lobelie, indian tobacco, pukeweed, vomit wort, wild tobacco). Difficulty breathing and rapid heart rates are thought to be associated with this.

• Pennyroyal oil (Hedeoma pulegioides, lurk-in-the-ditch, mosquito plant, piliolerial, pudding grass, pulegium, run-by-the-ground, squaw balm, squawmint, stinking balm, tickweed). Liver and kidney failure, nerve damage, convulsions, abdominal tenderness, burning of the throat are risks; deaths have been reported.

• Scullcap (Scutellaria lateriflora, blue pimpernel, helmet flower, hoodwort, mad weed, mad-dog herb, mad-dog weed, quaker bonnet, scutelluria, skullcap). Abnormal liver damage.

• Yohimbe (Pausinystalia yohimbe, johimbi, yohimbehe, yohimbine) Blood pressure changes, heart beat irregularities and heart attacks have been reported.

Experts say it's important to tell your doctor about any dietary supplement you may be taking. Not only do many supplements have significant side effects, but they may also interfere with the effectiveness of prescribed medications, such as birth control pills.

SOURCES: Consumer Reports, May 2004. News release, Consumer's Union. FDA. Institute of Medicine.