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New Quality Seal Empowers Consumers (continued)

First test results: ginkgo biloba

ConsumerLab.com chose ginkgo biloba for its first round of testing, purchasing 30 brands from a variety of retail stores and outlets. Names of 23 passing brands were posted on the ConsumerLab web site on November 16, 1999 -- together with details of the specific tests used, minimum potency levels of five chemical compounds required to be present, and general information about ginkgo biloba.

Additional products to be tested this year

During this coming year (2000), ConsumerLab also plans to test calcium, chondroitin, echinacea, garlic, ginseng, ginkgo biloba, glucosamine, SAMe, saw palmetto, St. John's wort, vitamin B complex, vitamins C and E, and multivitamins. Results for saw palmetto are scheduled to be reported on January 31, and results for glucosamine and chondroitin products in February.

Failing brands

According to Dr. Cooperman, ConsumerLab.com has received "thank you" email from consumers, pharmacists, health food stores, and researchers with only one complaint: Site visitors want the names of failing brands.

Cooperman's response? "We use a carrot, rather than a stick. ConsumerLab informs manufacturers of test results." Cooperman also notes that manufacturers of several failing brands have told him they are changing product formulas to match clinically proven ingredients, and believe their reformulated products will pass ConsumerLab tests.

Which brands to test?

Any single herbal may be represented by dozens, or even a hundred or more branded products. "We would prefer to test every product out there," Dr. Cooperman says, "but that would be prohibitively expensive, so we focus on what will be of greatest value to consumers." Based on market research, ConsumerLabs examines the top 30 brands based on national use and availability.

Brands that are not chosen for initial testing rounds can participate in ConsumerLab's Ad hoc testing program: For a moderate fee, ConsumerLab will test any brand on request. Those that pass receive the same benefits as other passing brands (web site posting and eligibility to license the ConsumerLab quality seal).

Is testing truly independent?

One of the most important questions in evaluating any testing program is whether tests are performed independently of manufacturers' influence. ConsumerLab.com is an independent, privately financed organization. The company does anticipate significant operating revenues from quality seal licensing. But this is the company's only connection to the manufacturers whose products they test.

Notably, an approach similar to that taken by ConsumerLabs has long proven effective in the computer industry, where manufacturers of technical products routinely present standard models to independent testing laboratories for evaluation and certification. Such tests, which follow protocols established by national standards organizations, are an absolute precondition for product liability insurance coverage. Insurance providers (in litigation parlance, the "payers of last resort") have a clear economic interest in supporting the highest levels of quality assurance.

This approach is notable in that it takes place entirely without government intervention. In an industry which has created the PC and the World Wide Web, independent testing as part of a free market approach to quality assurance has proven immeasurably productive. Whether it will become accepted practice among producers and consumers of dietary supplements remains to be seen.

Reaction from industry trade associations

Corinne Russell, a spokesperson for the Consumer Health Products Association, says that "A better solution than creating new quality seals is for the FDA to enforce DSHEA, which has full authority to do. DSHEA already requires that bottle contents match the label. We favor strong but reasonable enforcement of current law."

According to Michael McGuffin, President of the American Herbal Products Association, "ConsumerLab is doing great work. By providing third party certification, they are acting as a supportive critic of the industry as a whole. Seven companies got a wake-up call that their products do not meet scientific standards. This process will help the industry develop unified positions on what compounds to test for and what test methods to use."

Dr. Phil Harvey of the National Nutritional Foods Association (NNFA) says that testing botanical products is quite challenging because other substances in a product (such as another plant or various inactive ingredients) can sometimes distort test results. Aside from this concern, Dr. Harvey states, "There is obviously widespread interest in having some kind of quality test results made available to consumers, whether this is done through a private quality seal or industry self regulation, so having a quality seal is basically a good idea."

Noting that ConsumerLab's licensing and ad-hoc testing fees are "somewhat expensive," Dr. Harvey also says, "Having yet another logo may or may not confuse consumers. We'll have to wait and see if the ConsumerLab seal becomes widely accepted as a standard for the industry as a whole." NNFA's TruLabel program tests to see if bottle contents match the label, but has no associated seal. TruLabel test results are published in NNFA Today, a newsletter for NNFA members. NNFA's Good Manufacturing Practices program does have a seal; companies that pass inspection can place a special logotype on their labels.

Dr. John Cardellina of the Council for Responsible Nutrition notes that "CRN applauds anyone who is raising the standards of quality in the industry, and the general concept of a quality seal is a good one. However, when a product doesn't appear on the ConsumerLab list, consumers might assume it has failed the test -- but it might be a high quality product that simply was not tested."

Dr. Cardellina is also concerned that consumers will be inundated by the current proliferation of seals (NNFA's GMP seal, Paracelsian's BioFIT seal, ConsumerLab's seal, USP's seal), and wonders if any specific one will become broadly accepted. Says Cardellina, "Quality is the biggest issue facing the industry," -- while welcoming an industry-wide consortium for developing uniform quality standards.

Impact of testing on supplement quality

The ConsumerLab approach to testing and quality certification fills an obvious need. Consumers want to know if a particular bottle contains an effective product whose formula provides proven health benefits. Scientifically validated quality seals backed by rigorous testing programs offer a simple, highly visible method for identifying brands that meet high standards.

Increasing numbers of consumers are likely to use quality seals as a measure of a product's effectiveness. Others will continue to rely on their knowledge of a particular manufacturer's quality practices, or on their personal experience of a product's effectiveness. Overall, quality certification holds manifold benefits for producers, consumers, and insurers alike: the assurance that "what's on the label is in the bottle."

This apparently simple, yet somewhat elusive standard is critical to individual consumers as well as large-scale health care delivery systems. Validating dose and content levels in dietary supplements is a small but critical step in the path for better health at lower cost for all.

One impact of this approach is already being seen: Several manufacturers are changing product formulas to match standards established by clinical research. More are sure to follow. Companies with products containing different formulations will need to offer persuasive alternative evidence of the effectiveness of their product, or risk dwindling sales revenue.

Only time will tell if the ConsumerLab quality seal will become a widely accepted industry standard. But one thing is clear: Both consumers and health practitioners are demanding quality standards for supplements. If producers and their trade organizations do not take the next step and establish democratically constituted bodies for setting standards, then government will step in and do it for them.end-of-story

previous page New quality seal empowers consumers
How can consumers gauge the effectiveness of a dietary supplement? A new quality seal helps separate the wheat from the chaff

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Copyright 1999 ConsumerLab.com; reprinted with permission.




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