Raising the Herbal Bar

New certification program to set standard for supplements

TUESDAY, Oct. 16, 2001 (HealthDayNews) -- When you pop that echinacea tablet to help your cold, it's a crapshoot as to whether you're really getting that herb, thanks to the fact that supplements lie outside of the reach of regulators.

But that's about to change, says the organization that sets voluntary standards guaranteeing vitamins and herbal supplements are what they say they are. Designed to gain consumer's confidence, U.S. Pharmacopeia (USP) of Rockville, Md., says that beginning in 2002, its USP mark on a dietary label supplement will mean that what's on the label is what's in the pill. USP is a non-profit, non-governmental organization that sets standards to ensure the quality of medicines for human and veterinary use. It has set standards for about 3,400 prescription and non-prescription drugs.

Outside what's listed on the label, you really don't know whether the quality or the quantity of an herbal supplement is good or true, says Forouz Ertl, the USP vice president who is overseeing the certification program for dietary supplements.

"The principle behind our new certification program is to insure that quality systems are in place at the manufacturer's facility," Ertl says. "We will audit that facility. The company will have to be in compliance with USP's good manufacturing standards as well as be in compliance with the rules for dietary supplements published by the U.S. Food and Drug Administration (FDA). In addition, we will look at a company's documentation for quantity control, which will go under extensive review by USP's scientific staff."

"In other words, we will test the products submitted to the program, and then, when we test the products and they are in compliance with their labels and meet our standards, the manufacturer will be allowed to label the supplement with a USP certified mark," Ertl says. "As an example, you go to the market, and you buy echinacea. As a consumer, you need to know which species of echinacea you are buying, since there are three species. If the product has a USP symbol on it, the bottle contains that specific species in exactly the amount specified on the label."

Dietary supplements come in many forms, including tablets, capsules, powders, soft gels, gel caps and liquids. Though commonly associated with health food stores, dietary supplements also are sold in grocery, drug and national discount chain stores, as well as through mail-order catalogs, TV programs, the Internet and direct sales. In 1996, sales of dietary supplements topped $6.5 billion in the United States, reports the FDA.

The federal law known as the 1994 Dietary Supplement Health and Education Act (DSHEA) requires manufacturers of dietary supplements to ensure that products they sell are safe. But unlike regulations that govern drugs or food additives, supplement manufacturers do not have to provide information to the FDA to get a product on the market. And the FDA is not required to review and approve dietary supplement ingredients and products before they come to market.

So will a USP symbol mean the dietary supplement is safe or that it works?

"USP does not deal with safety and efficacy," Ertl says. "But the certification program is going to help the consumer have confidence that if the bottle has a USP label on it, the product itself has been tested, certified, including the manufacturing facility, and the consumer can have greater confidence in the product."

USP announced the new certification program at last week's Natural Products Expo East in Washington, D.C.

"This is very good news," says Charles Fetrow, author of The Complete Guide to Herbal Medicine and a clinical specialist at the University of Pennsylvania Medical Center Passavant in Pittsburgh. "The FDA commissioned an ad hoc committee a number of years ago, and this is really an FDA/USP partnership in an effort to get the herbal industry standardized. It's a great idea and I'm all for it."

Given the number of herbal supplements, Fetrow says it's going to take some time before the entire program is in place. "There are all kinds of standards to set. Things like heavy metals; you want to keep those out. So they will set maximum thresholds for heavy metal content. They will set maximum thresholds for contaminants, or standards for moisture contents or a standard for insoluble matter."

"There's certainly a need for it," Fetrow says. "Every company that's producing these things should adopt these standards. It's voluntary now, but who knows what's going to happen in the future?"

What To Do

For more information on dietary supplements, see the Center for Food Safety and Applied Nutrition. And for more on the new certification program, see the USP, but you'll need Adobe Acrobat to read it.

For more about herbal supplements, check American Herbal Pharmacopoeia.

SOURCES: Interviews with Forouz Ertl, D.V.M., vice president, USP, Rockville, Md., and Charles Fetrow, Pharm, D., clinical specialist, University of Pennsylvania Medical Center Passavant, Pittsburgh, Pa.; Oct. 12, 2001, U.S. Pharmacopeia and Dietary Supplements
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