What's Really In The Bottle?
December 1999

Most manufacturers say they use the highest quality production standards, yet until very recently there have been few independent certification or inspection programs serving the industry. Alarmingly, several recent stories in the media have claimed that some brands don't actually contain the full potency of substances as stated on their labels.

ConsumerLab.com is a new organization that provides independent testing of a wide range of health and nutrition products, including vitamins, minerals, herbals and other supplements. Subsequent to testing, ConsumerLab.com will publish the names of passing products/manufacturers on their website. Then, manufacturers whose products pass ConsumerLab tests can purchase a license to carry the ConsumerLab certification seal on their label.

Notably, ConsumerLab.com plans to test off-the-shelf samples of herbs and dietary supplements, then publish results without first informing manufacturers. This approach, originally pioneered by Consumer Reports, is one way the company will analyze and report to consumers. Companies whose products were not included in the initial set of tests can request that ConsumerLab test their products as well. On November 16, 1999, ConsumerLab published their first test results: the names of 23 products containing ginkgo biloba that passed these tests.

ConsumerLab.com is testing for accuracy (does the bottle contain what the label says it contains), consistency (does each tablet contain the same amount as the other tablets in the bottle), and purity (is the product free of contaminants). Read more about it on their website: www.ConsumerLab.com.

Are products adequately made?

The Good Manufacturing Practices (GMP) certification program of the National Nutritional Foods Association (NNFA) is already underway. Passing this rigorous third party inspection system entitles a company to use the NNFA's GMP seal on their product labels. Two manufacturers have already passed the program's requirement and thirty more are scheduled for audits as of this writing.

The NNFA requires all of their members who manufacture dietary supplements to meet these GMP quality standards for testing of raw and finished materials, staff training, cleanliness, equipment maintenance and record keeping. They estimate that all their members will have gone through this inspection and certification process by 2002. For more information about the NNFA's GMP and TruLabel programs, see the Science and Quality Assurance section of their website: www.nnfa.org.

Will this product really work?

Another laboratory, Paracelsian Inc. (Ithaca, NY), has tackled the complex question of testing herbal products to see if they actually produce biological activity associated with their claimed benefit. According to Paracelsian's Director of Business Development, Jeffrey Morrison, "Many herbal supplements are `standardized' to a specific plant component or components called `marker compound(s).'" The standardized marker may or may not be the active component of the herb.

Paracelsian's BioFIT[tm] quality control certification program is designed to ensure that individual product batches show consistent activity associated with claimed benefit. Says Paracelsian's Dina Berlin, "Herbal products are complex mixtures of naturally associated compounds. Biological activity can result from more than one constituent, and these constituents can act synergistically. Even though the active component(s) of an herb is sometimes difficult to determine, activity is not. Measuring for consistent activity using bioassays that mimic the human response ensures that consumers get the same product and benefit from bottle to bottle, even if content varies slightly. Paracelsian's BioFIT[tm] quality control certification program is designed to ensure that individual product batches show consistent activity associated with claimed benefit."

Also, according to Berlin, Paracelsian has completed its first wave of research and developed a certification program for five herbs (two assays have been developed and validated to pharmaceutical standards for each of the five): St. John's wort, echinacea, saw palmetto, ginseng, and ginkgo. Paracelsian's BioFIT[tm] tests can be used on both raw materials and finished products. Products that have passed their tests are eligible to carry Paracelsian's BioFIT[tm] certification symbol. For more details, see the BioFIT section of Paracelsian's website: www.paracelsian.com.

Making quality choices

While many of the programs reported above are still in development, the rigor and comprehensive approach taken by all three testing organizations promise to advance the cause of quality in dietary supplements. Earlier, we interviewed Michael Lange at Industrial Labs, a Denver-based organization whose Institute for Nutraceutical Advancement (INA) represents a joint effort with thirty major manufacturers of dietary supplements, together with several trade organizations and the FDA. The INA's Methods Validation Program is working to develop reliable, standardized tests of botanical substances and products.

Even though these programs are new and evolving, one thing is clear: Products that bear the quality seals of one or more of these four programs are more likely to be reliable, consistent in content, safe, and to provide claimed biological activity.