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Enter Supplement Quality, Stage Right . . .

Plot twists in the health-claim scenario

RDIA membership is in large part defined by large, multinational food manufacturers -- who want to make health claims about functional foods (which combine a botanical supplement with a food, such as breakfast cereals, soups and teas). In order to make such claims, they need to have evidence that the scientific community will accept.

However, any research that a company conducts on the safety or effectiveness of a supplement would benefit all manufacturers of that supplement. Since plants cannot be patented, anyone can produce a supplement to the specifications that research has found to be effective -- and can make health claims based on that research. But here, the plot thickens:

In order to protect their investments in research, the members of RDIA want exclusive rights to these validated health claims -- and conference participants agreed this would be possible to arrange. Even though any supplement producer can publicize scientific findings in their marketing materials, only one manufacturer would be able to use the validating seal. One suggestion for accomplishing this is to have a waiting period of several months (perhaps 6, 12 or 18 months) between validating one manufacturer's health claim and investigating a similar claim from another manufacturer.

A validating seal of approval for health claims would enable consumers to rely on specific products that had earned the seal, but like many a modern-day hero, this initiative also has a dark side: "Giving a validated seal of approval to only one manufacturer when dozens of other manufacturers' products are equally effective discourages competition and is not in the best interests of the consumer," according to Candace Campbell, Executive Director of the American Preventive Medical Association (APMA).

Act four: Testing the products

The curtain rises next on the issue of testing the products themselves: the classic question of what's really in this bottle. In the opening scenes of this act, the spotlight shines on the previously mentioned ConsumerLab.com, a private laboratory that conducts randomized, off-the-shelf testing of supplements and publishes the names of passing brands on their website, www.ConsumerLab.com. Companies whose products pass the tests can license the ConsumerLab quality seal to put on their label and marketing materials.

According to Lisa Savin, VP of Business Development at ConsumerLab, business is booming: "More companies are licensing our seal and asking to be among the first group of products tested in a particular category -- as well as asking that their products be tested in our ad hoc program." Approximately 85 percent of ConsumerLab's 25,000 email subscribers are individual consumers who want to stay apprised of supplement testing news.

Another seasoned performer now entering the drama is NSF International (NSF) -- formerly the National Sanitation Foundation -- which is developing a third-party testing and certification program for dietary supplements. Founded in 1944, NSF develops quality standards in the areas of public health safety and environmental protection, most notably in such little-noticed but critical areas as bottled water products and supermarket baked goods. Products with the NSF certification mark have passed third-party tests of manufacturing processes as well as product quality, purity, and shelf-life.

In addition to offering a certification program, NSF plans to write an American national standard for dietary supplements. This, like NSF's other standards, would be designated as an American National Standard through the American National Standards Institute (ANSI). ANSI is the national authority on industrial and consumer standards formed at the beginning of the 20th century as a means to promote consistency in industry and the sciences.

The US Pharmacopoeia (USP) is now developing a business plan for a quality certification program that would cover both verification (that a bottle's contents match the stated amounts on the label) and GMPs (inspection of manufacturing plants). The plan would also address marketing surveillance: that products conform to claims made on the label. The USP will present this plan to its Board of Trustees in January 2001.

Behind the scenes: Making sure tests are reliable

Like all productions, ConsumerLab's success story would not be possible without the contribution of experts working behind the scenes. In this case, most of the testing procedures used at ConsumerLab were screened and evaluated by the Institute for Nutraceutical Advancement (INA) in their Methods Validation program. In testing botanicals, it is crucial that any testing method be reliable, meaning that different labs who test the same sample will get the same results -- and rigorous, meaning that the test can be used on different kinds of samples and still determine what that sample contains.

(For more information on the challenges of testing botanicals, see also our interviews with Mark Blumenthal at ABC and with Loretta Zapp and Mark Lange at INA.)

next page Act five: Ensuring product quality
Randomized, off-the-shelf testing is an essential part of quality assurance -- but ultimately is little more than a single snapshot . . .

previous pageAct two: Reference materials
Like a fingerprint in a "whodunit" . . .

1st page of storyEnter Supplement Quality, Stage Right
In the ongoing drama of controversy surrounding nutritional supplements . . .



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