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Enter Supplement Quality, Stage Right . . .

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 of the final moment of one performance of the play. In life as in art, reaching a satisfactory conclusion to the quality drama depends on every moment of every performance. Accomplishing this means following a consistent set of good manufacturing practices (GMPs) every day of the week.

In the GMP scripting scene, the dramatis personae are made up of an ensemble cast of supplement industry trade organizations. The American Herbal Products Association (AHPA), National Nutritional Foods Association (NNFA), Council for Responsible Nutrition (CRN), and Consumer Healthcare Products Association (CHPA) have jointly developed a draft set of GMPs that were submitted to the Federal Drug Administration (FDA) in 1995. The FDA subsequently published this draft as a proposed rule in 1997, but these GMPs are still not finalized. As a result, chaos is rampant backstage: Some companies are still using the currently required level of food GMPs, while others have adopted stricter procedures, and a few are using the more stringent pharmaceutical level GMPs.

Stepping forward from the chorus line to take a "solo turn" is the National Nutritional Foods Association (NNFA), which began a mandatory GMP inspection program for its membership in 1999 with a 3-year compliance period. "Seventeen of our member companies are already certified," according to Dr. Phillip Harvey, NNFA's Director of Science and Quality Assurance, "and another 60 are currently in the pipeline for inspection." Even though this program has since become voluntary, consumers can be assured that any product with NNFA's GMP seal on its label has gone beyond the dress rehearsal stage and is following consistently high quality production procedures that are appropriate for dietary supplements.

Previews of coming attractions

Finally, the grande dame of industrial quality accreditation -- the American Society for Quality (ASQ) -- is the "keeper of the flame" for GMP programs at the system level and would therefore be involved in any international accreditation of dietary supplement quality.

While the ASQ has virtually no public visibility, its presence is ubiquitous throughout industry, where it teaches quality-control management and auditing methods to industrial and production engineers. Ultimately, it serves as arbiter of the obscure but extremely important process of optimizing and certifying the information systems that are the heart and soul of modern manufacturing practices.

ASQ's Food, Drug and Cosmetic Division (FDC), although only a fraction of overall membership, currently focuses primarily on educational programs that help its 6000 members run quality assurance programs as a means to adhere to GMP standards in FDA-regulated industries. How the ASQ will deal with the supplement industry is still an open question and will be reported on more fully at a later date.

next page The denouement: Quality emerges as the star
Are these fledgling projects -- to paraphrase Shakespeare -- much sound and fury signifying nothing? Or do they have real value . . .

previous page 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 . . .

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



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