Industry Leaders Form Quality-Certification Alliance
by Wyn Snow, Managing Editor
International and the National Nutritional Foods Association have
jointly announced a strategic alliance to integrate their plant
inspection and certification programs. At the same time, NSF has
announced the first "graduates" of its product certification program.
Through standardized testing, an area in which NSF has substantial
expertise, consumers are assured that supplement products will meet
minimum labeling standards. The two organizations, while little
known to the general public, are both dominant factors in their
National Nutritional Foods Association (NNFA) is the nation's largest
and oldest trade association for natural products. The organization
is made up of nearly 4,000 retailers, manufacturers, wholesalers
and distributors of natural products (including foods, dietary supplements,
and health and beauty aids).
International is a not-for-profit organization that offers independent
testing, certification, auditing, and toxicology consulting services
throughout the world. It has developed a variety of national and
international standards and certification programs for food and
400 employees and laboratories located throughout the US and Europe
make NSF a world leader in pure water and perishable food products
food testing. With its NNFA agreement successfully concluded and
a new supplement certification program in place, NSF becomes a significant
factor in supplement manufacturing and quality assurance.
manufacturing practices (GMP) certification
the partnership, NSF will use NNFA's GMP materials as part of its
plant inspection process and will recognize NNFA's GMP audits as
meeting the requirements for NSF's Dietary Supplements Certification
Program. Both GMP programs are based on a proposed set of GMPs developed
by four industry trade associations that were submitted to the FDA
in 1995. These proposed GMPs are designed to address the unique
circumstances of dietary supplement production.
to passage of the Dietary Supplement Health and Education Act of
1994, supplements were regulated as foods, and thus were required
to meet US Food and Drug Administration (FDA) regulations on GMP
standards for foods. The new set of GMPs for dietary supplements
are more stringent than those for foods, but less stringent than
those for pharmaceutical or over-the-counter drugs.
FDA published a proposed rule for GMP standards based on those developed
by the trade associations, but has yet to act on their final adoption.
The agreement between NNFA and NSF means that the private sector
has moved ahead of federal regulators in strengthening quality assurance
and NNFA together cover entire industry
alliance will enable all supplement manufacturers both to gain GMP
certification and to have products tested and certified. NNFA's
GMP inspection program has already encompassed more than thirty
companies, but does not cover testing of products. Also, manufacturers
who were not members of NNFA could not participate in the NNFA GMP
certification program. The alliance between NNFA and NSF covers
Tom Harkin (D-Iowa) commends the two organizations for "their commitment
to ensure dietary supplements are produced to high standards and
are accurately labeled." According to Harkin, " These organizations
have picked up the ball that the FDA dropped in not issuing GMP
regulations. Both these programs represent another important step
toward the dietary supplement industry's goal of ensuring product
quality and consumer safety."
Jaglowski of NSF International observes, "Combining our 57-year
testing and certification experience with NNFA's GMP expertise will
enable us to offer dietary supplements manufacturers and ingredient
suppliers the most comprehensive certification program available.
The NSF Mark on dietary supplements labels will reassure consumers
that these products conform to the highest standards for Good Manufacturing
cover wide range of plant manufacturing practices
order to earn certification, companies must pass a stringent and
thorough set of inspections by a third-party auditor. Program requirements
and process controls
(See sidebar for details of
requirements for GMP inspections.)
such as those just announced by NNFA and NSF represent a significant
advance for those who use and recommend supplements. Purity, dosage
size and shelf life are significant factors in processing or manufacturing
any food, supplement or drug product.
programs that are national in scope, represent broad consensus and
are scientific in their methodology yield manifold benefits. Producers
large and small now have a uniform set of achievable standards,
distributors have a basis for marketing products as pure, and users
have the assurance that "what's on the label is also in the bottle."
For both medical and alternative health providers, quality is an
invaluable aid to assuring patients are receiving pure supplements
at accurate dosage levels. It is notable that the plan is being
carried out as a private sector initiative at no direct cost to
the public and on a substantially faster track than is usually the
case in government-sponsored programs.
and NSF International
(www.nnfa.org) is headquartered
in Newport Beach, California. NSF International (www.nsf.org)
is headquartered in Ann Arbor, Michigan, and has offices and laboratories
around the world.
International. Draft Standard for Dietary supplements. Ann Arbor,
MI: NSF International, Publication #NSF 173-2001, 9 July 2001.
Pompliano, Business Development Manager, NSF International.
Taylor, Director of Communications, NNFA.