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Herbal supplements: they may be ‘natural' but are they safe?

by Michelle Badash, MS

Michelle Badash, MS

In June 2001, the US Food and Drug Administration (FDA) issued a warning about dietary supplements containing aristolochic acid, an ingredient found in certain herbal remedies for conditions ranging from bladder problems to obesity, because of reports of kidney failure. Although aristolochic acid has not been proven conclusively to be the cause of the kidney failure, the FDA was concerned enough about the risk to issue this warning.

Previously, the FDA issued a warning about products containing ephedra, an ingredient found in supplements touted to promote weight loss and improve workouts. Ephedra was linked to 40 deaths and cases of serious illness, including heart attack, seizure, hypertension, arrhythmia and stroke.

Getting serious about supplements

Dietary supplements are big business. In 1999, $31 billion was spent on herbs, vitamins, and minerals. But as the dietary supplement market grows, many people are starting to ask whether supplements safe enough.

The politics of regulation

Unlike prescription medications, which must undergo rigorous scientific research before receiving FDA approval, dietary supplements are not required to undergo such testing. Thomas J. Moore, a health policy analyst at George Washington University, noted in an article on Salon.com that "dietary supplements don't meet the level of standards that my hair dryer has to meet."

There are several reasons why supplement standards are so different from medication standards:

Economics - Most supplement manufacturers lack the funds necessary to perform the rigorous clinical research on their supplements that the FDA mandates of drug companies. In addition, herbs cannot be patented (as drugs are), so supplement manufacturers cannot expect the same financial return on investing in research as drug manufacturers reap.

Assumption of safety - Many consumers have the misconception that herbs are completely safe because they are natural.

Politics - There are complex political influences at work. Congressional leaders—many of whom receive substantial funding from the nutrition supplement industry—have allocated limited funds to the FDA to oversee dietary supplement problems. Click here for specific details of the Dietary Supplement Health and Education Act of 1994.

FDA does regulate labeling of supplements

The FDA does, in fact, have strict policies regarding labeling language for unsubstantiated claims and unsafe products. For example, supplement manufacturers are not allowed to print explicit statements on packages regarding a product's effectiveness for treating a specific condition. The Council for Responsible Nutrition and the American Botanical Council say the problem is not so much a lack of regulation, but lack of enforcement.

New certification program for supplements

In an effort to encourage self-monitoring of the dietary supplement industry, the OSHA-accredited company NSF International recently established an independent certification program for dietary supplements. NSF will test products that are voluntarily submitted by their manufacturers and affix their certification seal to products that are approved.

Choosing safe herbs

For now, take the following steps to protect yourself:

  • Read labels carefully.
  • Buy well-established supplement brands.
  • Carefully consider the risks associated with consuming some of these products (see list below).

Be sure to discuss long-term use of any supplement with a health care professional. And always notify your doctor of supplements you take to insure that there are no adverse interactions with any prescription medication you take.

Potentially dangerous ingredients

The following is a list of ingredients that have been found to cause adverse reactions in certain groups of people. These herbs may be sold individually, or as an ingredient in other products, so always check labels.

Name

Used for

Potential effects

Other info

Aristolochic Acid

Variety of ailments, including weight loss

Kidney damage

Ingredient may be listed as "Aristolochia," "Bragantia" or "Asarum."

Chapparal

(Creosote bush)

Cancer cure, acne treatment

Liver damage

Most products containing chapparal have been removed from the market.

Comfrey

Asthma, tuberculosis, burns, stomach problems

Liver damage

As of July 2001, the FDA and Federal Trade Commission issued new warnings about comfrey, citing concerns of toxicity and potential cancer risk. Products containing comfrey will be removed from sale, and should not be used.

Yohimbe

Body building, enhanced male sexual performance

Kidney failure

Adverse effects when taken with certain foods and over-the-counter drugs. Should be avoided by people with diabetes, heart, liver or kidney disease, or low blood pressure.

Lobelia

Cough suppressant, fever reducer

Depression, respiratory problems

Should not be used by children, infants, pregnant women or smokers.

Germander

Weight loss

Liver damage

Willow bark

Pain killer, fever-reducer

Should be avoided by people sensitive to aspirin.

Ephedra (Ma Huang)

Weight control, energy stimulant

High blood pressure, stroke, rapid heart rate

St. John's Wort

Antidepressant

Recent study suggests that it may interfere with the AIDS drug Indinavir. Some adverse reactions may be caused by sun exposure.

Ginkgo and Ginseng

Memory enhancers

Can reduce blood sugar in people with diabetes. Do not use while taking blood-thinning medication or aspirin.

Resources

Food and Drug Administration
Center for Food Safety and Applied Nutrition
"Dietary Supplements: Warnings and Safety Information"
http://www.cfsan.fda.gov/~dms/ds-warn.html

Council for Responsible Nutrition
http://www.crnusa.org

American Botanical Council
http://www.herbalgram.org

NSF International
http://www.nsf.org


Last reviewed August 2001 by Medical Review Board



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