Product regulations. Echinacea

The regulation of Echinacea products in the United States would fall under the Dietary Supplement Health and Education Act of 1994 (DSHEA). In the United States, statutory 403 (a)(1) of the Federal Food, Drug, and Cosmetic Act prohibits labeling that is false or misleading. Under DSHEA, a structure/-function claim can be made, provided the claim meets the criteria set forth in statutory 403(r)(6). Structure/function claims are permissible if a specific disease is not targeted, unless reviewed by FDA. A structure/function claim such as supports the immune system would be acceptable whereas alleviates the common cold or flu would not be acceptable for Echinacea because the claim targets a specific disease state (i.e., cold or flu). 

Echinacea is sold as a dietary supplement in the United States and as natural health products in Canada, while in Germany and many European countries, Echinacea products are sold as drugs in pharmacies (Bauer, 2000). There are a number of products on the market, which include dried herbal and root, alcohol tinctures and extracts, and expressed juice products, thus, standardization would be a difficult task. However, regulation would be less difficult because all of these products would fall under a dietary supplements category. 

There are several limitations that lead to potential for patient harm with the current regulation of herbals under the DSHEA. First, botanical nomenclature is not standardized. Common names for herbals may vary depending on the region of the country. A single herb may have more than a dozen common names (e.g., echinacea), or one common herbal name may refer to several different species (e.g., yellowroot and snakeroot). To avoid confusion, the American Herbal Products Association (AHPA) has published Herbs of Commerce, a text of more than 500 herbs with the preferred common name, Latin binomial, and appropriate synonyms. 

Some of the most popular nutraceutical products marketed today are botanicals such as St. John s wort, echinacea, ginkgo biloba, saw palmetto, and ginseng. Unfortunately, manufacturers are not required to prove their safety or efficacy before marketing them. Dosages are not standardized. The quality of the raw source and the plant parts used are not regulated. And, unlike prescription drugs or over-the-counter medicines, there is no federal quality... 

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