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Quality Control for Herbs, Vitamins

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TIMES HEALTH WRITER

Often without realizing it, consumers who buy vitamins, minerals and herbs at the pharmacy or health-food store may be taking a leap of faith.

Studies have shown that the vitamins and herbs we buy do not always contain the ingredients listed on the products’ labels--and there is no regulatory system in place to ensure accuracy in labeling.

With roughly half of Americans now taking some type of dietary supplement (vitamins, herbs, minerals and amino acids), several private groups are launching efforts to hold supplement makers accountable for the purity of their products. Two industry groups have set standards for manufacturers to help ensure quality products, while a New York company is testing popular herbal and other products and posting the results on its Web site.

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Even Good Housekeeping magazine is getting into the act, awarding its seal of approval to a handful of supplement products that are advertised in its magazine. (It is the magazine’s policy to test products before accepting advertising for them.)

“I don’t think there is any debate that quality control is a problem in the industry,” said John Cardellina, a vice president at the Council for Responsible Nutrition, a Washington, D.C., trade group for the dietary-supplement industry.

“About two years ago, a lot of people in the industry started discussing some kind of seal-of-approval program [to identify quality products],” Cardellina said. “A lot of people are rushing in now to fill the void.”

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ConsumerLab.com, a White Plains, N.Y.-based company founded last summer by a physician and a former natural-products chemist at the Food and Drug Administration, is testing natural products to see if they meet scientific standards for potency, purity and consistency.

“We see our role as defining a standard [for quality], because there isn’t a standard in this country,” said Dr. Tod Cooperman, ConsumerLab’s president. “And we’re going to go beyond that. Even if the label is correct, we’ll say if we think the product is up to acceptable quality or not.”

Good Housekeeping’s effort to evaluate dietary supplements is more limited in scope.

The magazine, which is known for lending its quality seal to products ranging from appliances to clothing, now requires dietary supplement companies that want to advertise in the publication to meet a standard for product purity. Three companies’ products have met that standard so far, said Donald Mays, technical director of the Good Housekeeping Institute, the magazine’s product-testing unit.

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“Part of what we do here is consumer education,” Mays said. “We want people to be aware that just because they see a product on their drugstore shelf that doesn’t mean it’s safe and effective.”

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Since dietary supplements are regulated as food products instead of drugs, manufacturers are not required to have their products reviewed by the Food and Drug Administration before marketing.

The FDA has the authority to spot-check supplements but is not required by law to test all such products. This leaves consumers in the dark about the relative quality of the supplements.

And there is good reason for consumers to be wary of what they are buying. Previous random testing of various supplements (undertaken by scientists, consumer groups or newspapers) indicates that many do not carry the amount of active ingredient stated on the label.

“It’s nearly impossible for people to judge what’s in these products,” said Cooperman, who founded, and later sold, a company that rated health-insurance plans. “You don’t know if it’s saw palmetto or sawdust.”

He noted that his company has focused on products sold by larger suppliers.

“We haven’t looked at the smaller ones,” he said, “which you would expect would have even less money to do quality-assurance testing.”

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Last week, ConsumerLab released test results for a variety of saw palmetto products. Saw palmetto is a popular treatment for symptoms related to prostate enlargement, or benign prostatic hyperplasia. Several studies have found that the herb improves urinary flow and reduces the frequency and urgency of urination in men with the problem.

Studies on the herb indicate that the main active ingredients of saw palmetto are fatty acids and sterols and that these substances should account for 85% and 0.2%, respectively, of the weight of a saw-palmetto product.

Of the 27 saw-palmetto products tested by ConsumerLab, five had labeling information showing fatty acid quantities below the 85% standard. Another product did not have enough information on its label to be tested.

Of the 21 other products studied, 17 met the 85% standard; four did not. Only two of the passing products appeared to contain exclusively a saw-palmetto extract similar to that used in research studies, Cooperman noted. Ideally, dietary supplements should be formulated to match the substance shown to be effective in studies.

“A lot of manufacturers seem to be cutting corners; putting less in, adulterating products with other types of oils,” Cooperman said. “That’s not necessarily unhealthy, but it wouldn’t have the clinical benefit.”

In its first analysis last summer, ConsumerLab examined leading ginkgo biloba products and found that 25% failed to meet the potency standard.

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And, next month, the company will release its third study, this one on glucosamine and chondroitin, a popular combination remedy for joint pain. Cooperman said the results will show a similar, if not worse, failure rate.

“I think once we’ve tested five or six [different types of supplements], we’ll have a pretty good idea about which companies are doing a good job across-the-board,” he said.

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Many supplement manufacturers want a fair evaluation process and are hopeful that ConsumerLab will provide that, said Cardellina of the Council for Responsible Nutrition.

Even so, companies aren’t thrilled at the prospect of ConsumerLab disclosing to the public the names of products that fail the quality-control test, Cardellina added. However, if ConsumerLab or other testing organizations don’t disclose the names of products that fail, consumers may assume that any product not listed as “passing” the test must have failed.

But ConsumerLab officials say they initially plan only to publicize those companies that pass its test, not those that fail.

“We don’t want manufacturers to see us as the enemy but as someone trying to help,” Cooperman said.

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At the request of The Times, ConsumerLab agreed to release information on the saw-palmettto products that both passed and failed its recent tests.

In addition to its own random testing--initially undertaken without the manufacturers’ knowledge and paid for by ConsumerLab--Cooperman said the company will test products at a manufacturer’s request for a fee. If a company’s products pass any ConsumerLab test, it can purchase the right to put the ConsumerLab “certification seal” on the product. Manufacturers that meet ConsumerLab’s standards will be allowed to advertise on the White Plains, N.Y.-based firm’s Web site.

ConsumerLab hopes to generate most of its revenue by licensing its data to third parties, such as consumer and health organizations, and businesses.

Cooperman is hopeful that the Web site will also help educate consumers. Besides listing product test results, the site includes an explanation of the scientific data supporting the efficacy of a particular supplement. Consumers are urged to consult with their doctors before using dietary supplements.

(BEGIN TEXT OF INFOBOX / INFOGRAPHIC)

Test Results for Prostate Supplements

ConsumerLab.com tested 21 saw palmetto products and found that 17 met the minimum requirement for potency.

Products that passed:

* Celestial Seasonings Prostate Health Ultimate Blend with Saw Palmetto, Berry and Standardized Extract, 320 mg./three capsules (106.66 mg./capsule)

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* Centrum Herbals Saw Palmetto, Standardized Extract, 160 mg./softgel

* CVS Premium Quality Herbs Saw Palmetto Standardized Extract, 160 mg./softgel

* GNC Herbal Plus Standardized Saw Palmetto (Extract), 160 mg./softgel

* MotherNature.com Standardized Saw Palmetto Extract, 160 mg./softgel

* Natrol Saw Palmetto (Standardized Extract) 160 mg./softgel

* Nature’s Way Standardized Saw Palmetto Extract, 160 mg./softgel

* Nutrilite Saw Palmetto (Standardized Extract) and Nettle Root, 106 mg./softgels (from Amway)

* One-A-Day Prostate Health, Saw Palmetto Standardized Extract, 160 mg./softgel (manufactured by Bayer)

* Pharmassure Standardized (Extract) Saw Palmetto, 160 mg./softgel (distributed by Rite Aid)

* Propalmex, Saw Palmetto Standardized Extract, 160 mg./softgel (manufactured by Sunsource, distributed by Chattem)

* Puritans’ Pride Saw Palmetto Complex with Pygeum, Saw Palmetto Standardized Extract, 80 mg./softgel

* Quanterra Prostate Saw Palmetto Standardized Extract, 160 mg./softgel

* Shaklee Formulas Saw Palmetto Plus, Saw Palmetto Standardized Extract, 160 mg./softgel

* Spring Valley Saw Palmetto Extract, 80 mg./softgel (distributed by Walmart, manufactured by NaturPharma)

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* Sundown Herbals Standardized Saw Palmetto Extract (with berry), 225 mg./capsule

* Walgreens Saw Palmetto Standardized Extract, 160 mg./softgel

Products that did not pass:

* Nature’s Bounty Herbal Sure Extracts Saw Palmetto 1,000 mg. (berry)/softgel (from 250 mg. of a 4:1 extract)

* Real Health, the Prostate Formula with Saw Palmetto, 320 mg. Saw Palmetto (berry powder) per 3 tablets (106.66 mg./tablet) (distributed by Real Health Laboratories)

* Ricola Herbal Health Prostate Formula with Saw Palmetto and Natural Vitamin E, 160 mg./tablet, Saw Palmetto Standardized Extract (85-95% sterols and fatty acids)

* The Vitamin Shoppe Saw Palmetto, 540 mg. (berry)/capsule

Source: ConsumerLab.com. Used with permission.

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