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.

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.

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 dont 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.

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 products 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.

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.

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.

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.