New Seals of Approval Certify Unregulated Herbs, Vitamins

New Seals of Approval Certify
Unregulated Herbs, Vitamins

At one branch of the national chain Vitamin Shoppe, there are 83 different types of calcium, 77 kinds of vitamin C and 22 distinct bottles of gingko biloba. Choosing between them could drive the savviest consumer to skip the herbs and go right for the Tylenol.

Several new "seals of approval" are vying to cut through the clutter of competing products in the largely unregulated $17 billion dietary-supplement industry. At least four outfits, from a nonprofit foundation to the venerable Good Housekeeping Institute, have begun or ramped up issuing official-looking stamps to herbs, vitamins and other supplements that meet certain standards.

Generally, the programs test and certify that the ingredients listed on the label accurately reflect the makeup of the pills inside the bottle. Most also purport to ensure that a substance is free of common contaminants, including heavy metals and pesticides. Two require companies to follow good manufacturing practices.

But while the seals give consumers some reassurance, they don't conclusively answer the most important questions on shoppers' minds: Is the product safe and does it work? And most of the programs require dietary-supplement companies to pay for the privilege of being tested and certified or to put the stamp of approval on their packaging.

Moreover, because the seals don't include fine print stating exactly what they do and don't certify, some people worry they will end up misleading consumers. "When a consumer sees that a supplement is verified, the natural assumption is that its efficacy and what is being claimed is verified, and that is just not true," says David Schardt, senior nutritionist at the Center for Science in the Public Interest, Washington, D.C.

Nevertheless, the new programs may help curb the Wild West nature of the dietary-supplement industry. Unlike pharmaceuticals, vitamins and herbs are only loosely regulated by the federal government. Manufacturers aren't required to prove their products' safety and efficacy prior to putting them on the market. If someone falls ill -- or even dies -- as a direct result of taking a product, the manufacturer doesn't have to report that either.

The laissez-faire regulatory environment has contributed to some scary outcomes: Earlier this year, an herbal remedy called PC-Spes that was used to treat advanced prostate cancer was taken off the market after it was found to be contaminated with a blood thinner. Also this year, a few European countries pulled kava, an herb used to treat anxiety, off store shelves after a handful of people developed dangerous liver ailments after using it.

The programs don't test for everything that could taint a product, or for possible side effects or dangerous contraindications with other herbs or drugs. Except for Good Housekeeping, they don't require scientific data to verify health claims. Still, the new programs tackle an issue that is rampant in the industry: that there are often wide discrepancies between how much of an active ingredient a capsule actually contains and what is stated on the bottle. For example, in a recent study in the Journal of Urology, seven vitamin E products that were analyzed were discovered to have from 41% less to 57% more of the stated active ingredient. Doctors hope that the new seals will give consumers better guidance than they have now. "People take things because their barber said it helped his knee pain," says Robert Bonakdar, a family physician in San Diego.

What Consumers Should Know

The most rigorous of the seals programs is run by the U.S. Pharmacopeia, which has been setting standards for prescription and over-the-counter drugs since 1820. A USP mark verifies that the product was manufactured in a clean, professional facility; that its contents are accurately reflected on the label; that it is free of common contaminants; and that it dissolves quickly enough in the stomach for the active ingredient to be absorbed by the body. But the USP program is new and consumers won't see any products bearing the USP mark on store shelves until this fall.

NSF International, a nonprofit founded by a group of University of Michigan professors in 1944 to set standards in the food-service industry, has a program similar to USP's. NSF, which now certifies everything from bottled water to chicken-processing machinery, launched its dietary-supplement program about a year ago and has now certified more than 60 dietary products, including some multivitamins and kids' supplements. (The list is posted on its Web site, www.nsf.org¹.) The company does follow-up tests twice a year on products bearing its seal and audits manufacturing practices annually. If a product flunks an NSF test, the manufacturer is given time to improve it.

But like other seals programs, including USP, companies must pay NSF to be tested. With price tags of about $5,000 for one product and $50,000 for a line of 20 products, it is likely that only larger manufacturers will be able to afford the program.

Of all of the certification programs, ConsumerLab.com has tested the most products -- more than 500 since the company was founded in 1999 by a former Food and Drug Administration chemist and a doctor. While USP and NSF test and certify products only from manufacturers that pay, ConsumerLab.com examines certain popular classes of supplements -- ginseng, for example -- without charging manufacturers. (Companies can pay ConsumerLab between $2,500 and $4,000 to make sure their product is included in testing. And they must pay $2,000 to $10,000 to use the ConsumerLab.com seal in advertising or on their bottles.)

Products that pass are posted on the company's Web site (consumerlab.com²). While part of the site is free, ConsumerLab.com charges a $17.95 yearly subscription fee, which includes the full list of products that passed the company's tests. Only companies that pay to get their products tested appear on the free site.

The Good Housekeeping Institute, whose seal graces trash bags and dishwashers, has "approved" a half dozen dietary supplements so far. The institute, the research arm of Good Housekeeping magazine, reviews manufacturing processes but conducts only limited testing. And only those companies that agree to buy advertising in the magazine can be considered for the seal. But the firm is unique in that it requires manufacturers to back up health claims that their products make by submitting evidence from a clinical trial that has been accepted by a peer-reviewed scientific journal.

Whatever the caveats, consumers like Joanne Waage say they welcome the additional guidance when vitamin shopping. Ms. Waage now relies on recommendations of friends, her local pharmacist and her mother when buying vitamin C and echinacea. "It is total hear-say," the 34-year-old author says. "I can't tell the difference by the package. Sometimes you don't even know what's in the bottle."

Write to Andrea Petersen at andrea.petersen@wsj.com³

Updated July 10, 2002