NEWS for North Dakotans
Agriculture Communication, North Dakota State University
7 Morrill Hall, Fargo, ND 58105-5665
July 22, 1999
There are significant differences between how drugs and herbal supplements are regulated in the United States. Because of those differences, one of which involves federal testing, people who buy herbal supplements need access to accurate information.
But before consumers begin educating themselves about specific herbal products or brands, a licensed, registered dietitian with the North Dakota State University Extension Service says they should be asking themselves some questions.
"First, ask yourself why you are taking it. Self-medication may treat symptoms but not the underlying cause," says Julie Garden-Robinson, extension food and nutrition specialist at NDSU. She suggests also asking these questions: Is there research-based information available about the product? What are the dosages and recommended forms? What are its side effects?
"For example, herbal products such as natural licorice, St. John's Wort and ginseng can all interact with blood pressure medications," Garden-Robinson warns. "That's why it's extremely important to inform your physician or other health care provider about the supplements you're taking--including vitamin and mineral supplements, not just herbal supplements."
For those consumers who have decided to begin taking herbal supplements, where should they look for accurate information? A key source is literally an arm's length away.
"Much of what a consumer needs to know to make an informed decision regarding herbal or botanical supplements can be found simply by looking at a product's label," says Ron Smith, extension horticulturist at NDSU.
Actually, what doesn't appear on a supplement's label might be a better indicator of product quality than what does. Smith recommends that consumers purchase only those herbal or botanical supplements whose labels feature the word "standardized" because these products contain measured amounts of the key ingredients. For example, each tablet in a standardized bottle of Valerian root (marketed as a sleep aid) would contain 500 milligrams of root extract, if so stated. But the per-tablet root content of a similarly labeled nonstandardized product could be wide ranging.
Along with the herbal supplement's common name (Valerian root, for instance), the product label should also feature the ingredient's botanical name (Valerian officinalis). Smith says the reason is that one plant may have several common names, but the inclusion of its botanical name on the label will eliminate confusion and thereby assure consumers that they are buying exactly what they want.
Reputable manufacturers will also print their company name and address on the label, along with a telephone number that is usually toll-free. Smith says, "The fact that a company has put a telephone number on its packaging and has taken steps to standardize its product indicates that it is willing to expose itself to scrutiny."
Consumers may become frustrated when shopping for herbal supplements because prices for similar products can vary greatly. But there are valid reasons why some products are more expensive, and here too, consumers can use label information to help determine value, Smith says.
The labels of some herbal supplements display the letters "GMP," which stands for Good Manufacturing Practice. Manufacturers of these products are complying with specific standards established by the Food and Drug Administration. Likewise, supplement labels carrying the letters "USP" (United States Pharmacopeia) signify products that are produced according to the same standards required for drugs sold in this country.
In 1994, Congress passed the Dietary Supplement Health and Education Act (DSHEA), and this law includes certain labeling mandates. For example, DSHEA allows statements on the labels of herbal supplements that describe the product's role in affecting or maintaining body structure or function. But those statements must be followed with a disclaimer: "This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease."
DSHEA also stipulates a presumption of safety, meaning that the FDA must now prove that an herbal or botanical supplement is unsafe before it can remove the product from the market. The FDA does not analyze any dietary supplements prior to sale. Nor do manufacturers and distributors need to register with the FDA or get FDA approval before producing or selling these supplements.
Smith says DSHEA's presumption-of-safety clause allows for more leniency in the regulation of herbal and botanical supplements compared to pharmaceutical products, and so it provides consumers with more choices, but it also burdens consumers with the responsibility of making good choices.
"Beware of low-priced products being marketed by obscure companies," Smith concludes. "Companies with well-recognized names are unlikely to jeopardize the reputation of their brand."
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Sources: Ron Smith (701) 231-8161
Julie Garden-Robinson (701) 231-7187
Editor: Dean Hulse (701) 231-6136