Labels on Popular Herbal Supplement Echinacea Frequently Inaccurate [balance]

Echinacea Products Often Not As Promised

Labels on popular herbal supplement frequently inaccurate

March 26, 2003 -- A new study provides yet another example of how you don't always get what you pay for when it comes to buying herbal supplements. A sampling of popular echinacea products shows that only about half actually contain the same amount of the herb indicated on the label, and many don't contain any echinacea at all.

Researchers say sales of echinacea represent about 10% of all herbal supplement sales in the U.S. Herbal supplements are currently not subject to FDA evaluation and approval, but the agency proposed new labeling standards for nutritional supplements to help ensure quality control earlier this month.

In recent years, echinacea has gained a reputation as an immune-system booster and cold fighter, although clinical evidence about the herbal supplement is limited. In addition, researchers say most consumers are not aware that there are three different species of echinacea, and each is responsible for different effects.

In the study, published in the March 24 issue of The Archives of Internal Medicine, researchers purchased 59 echinacea products from local retail outlets in the Denver, Colo. area in August 2000 and evaluated their contents.

Researcher Christine M. Gilroy, MD, of Presbyterian St. Luke's Hospital, and colleagues found that six (10%) of the products contained no measurable traces of the herbal supplement, according to laboratory tests. In fact, the contents were consistent with what was promised on the labels in only 52% of the samples.

The study found the labeling of the various tablets, capsules, softgels, and liquids varied greatly and only four (7%) met all four of the FDA's labeling requirements. Those regulations require that the label of nutritional and herbal supplements contain:

• The dietary supplement statement regarding suggested use of the product as a dietary supplement;
• A supplement fact box listing active ingredients;
• An FDA disclaimer, stating that the product is not intended to diagnose, treat, cure or prevent disease and any claims have not been evaluated by the FDA;
• Nutrition facts, listing nutritional information (calories contained, etc.).

The samples labeled as "standardized" were more likely than others to contain the labeled levels of the active ingredient than others. Researchers say many herbal preparations use the term "standardized" to imply that the herb contained in the product is uniformly comparable to other preparations of the same herbal supplement.

But researchers say the correlation between the labeled milligrams of the herb and the measured milligrams was weak in both standardized and nonstandardized preparations. Of the 21 standardized products, nine met the quality standard described on the label.

Researchers note that although dietary supplements remain unregulated by the FDA, the U.S. Pharmacopeia (USP) launched a program in February 2001 to ask manufacturers of dietary supplements to voluntarily comply with testing of ingredient samples and adhere to quality standards set by USP.