Supplement Quality, Stage Right . . .
five: Ensuring product quality
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.
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.
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.
of coming attractions
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.
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.
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.
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
. . .
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 . . .
Enter Supplement Quality, Stage Right
In the ongoing drama of controversy surrounding nutritional
supplements . . .