—particularly herbal remedies—are gaining popularity. Millions of Americans are spending billions of dollars on herbal supplements each year. But since the Dietary Supplement Health and Education Act (DSHEA) passed in 1994, regulation of these supplements by the Food and Drug Administration’s (FDA) has been severely restricted.
Under the DSHEA, it is up to supplement manufacturers to determine that their products are safe and that health claims they make are not misleading. The FDA can only monitor these supplements after they are on the market.
The DSHEA set forth certain restrictions for health claims associated with dietary supplements:
Claims that a supplement can prevent, treat, or cure a disease cannot appear on labeling or accompanying marketing material; the FDA considers any supplement that makes these claims “an unapproved—and thus illegal—drug.”
Structure/function claims (i.e., “calcium builds strong bones”) must include the following disclaimer: “This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”
But with so many herbal supplements being marketed on the Internet, it is next to impossible for the FDA to monitor all of them. A new study in the September 17, 2003 issue of the
Journal of the American Medical Association
reviewed 443 websites that contained information on the eight best-selling herbal products. Researchers found that most of the websites were selling the supplements, and over half of these websites contained illegal and misleading claims that their products can treat, prevent, diagnose, or cure specific diseases.
About the Study
The researchers used the five most commonly used search engines (Google, Yahoo, Ask Jeeves, MSN [Microsoft Network], and AOL [America Online]) to search for information on the eight best-selling herbal products (listed along with their commonly promoted uses):
Researchers analyzed the content of the 443 websites that were listed on the first pages of the search results. They documented the nature of the site (retail or non-retail) and whether it was a sponsored link (had a fee-based arrangement to be featured prominently by a search engine). They also analyzed all health claims, disclaimers, and references on the website.
After reviewing the websites, the researchers determined that:
76% of the websites either sold the product or directly linked to a vendor that did
27% were sponsored sites
81% of the retail websites made one or more health claim
55% of the health claims stated that the product could treat, prevent, diagnose, or cure specific diseases
52% of the websites with health claims omitted the standard FDA disclaimer
Only 12% of the websites provided referenced information without a link to a distributor or vendor
Important information that could affect consumers’ health was often left out of these websites. For example, 24 of the 62 kava kava retail sites failed to mention that kava kava has been linked to liver failure, and 11 of the sites proclaimed that kava kava was safe with few or no adverse effects.
How Does This Affect You?
This study showed that much of the information about herbal supplements on the Internet is misleading. Many of the websites analyzed in this study contained illegal health claims and information that could potentially harm consumers’ health. This is alarming, considering that a recent survey showed that more than half of Internet users reported that they thought “almost all” or “most” of the health information they encountered on the Internet was credible.
Many people consider “all-natural” herbal products safe and are unaware of their potential dangers. Like pharmaceutical drugs, dietary supplements can cause adverse reactions and may interact dangerously with other medications. For instance, another study in the same issue of the
found that St. John’s wort increased the activity of cytochrome P450 3A4, an enzyme in the liver that affects the metabolism of at least 50% of all marketed medications. These findings suggest that long-term use of St. John’s wort may diminish the effectiveness of other medications, which could adversely affect patients taking both.
Until supplements are regulated more strictly, there are some things you can do to protect yourself. First, be aware that the health claims provided by a supplement manufacturer are not well regulated by the FDA. Also, make sure you get your information from a reliable source—one that is not trying to sell a product and that provides references for the information it puts forth. Finally, make sure to tell your physician about all of the supplements you are taking so you can avoid adverse effects and dangerous drug interactions.
Please be aware that this information is provided to supplement the care
provided by your physician. It is neither intended nor implied to be a
substitute for professional medical advice. CALL YOUR HEALTHCARE PROVIDER
IMMEDIATELY IF YOU THINK YOU MAY HAVE A MEDICAL EMERGENCY. Always seek the
advice of your physician or other qualified health provider prior to
starting any new treatment or with any questions you may have regarding a