Two Industry Leaders Form Quality-Certification Alliance
6 December 2001
by Wyn Snow, Managing Editor

NSF 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 fields.

The 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).

NSF 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 drinking water.

Almost 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.

Good manufacturing practices (GMP) certification

Through 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.

Prior 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.

The 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 standards.

NSF and NNFA together cover entire industry

The 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 these gaps.

Senator 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."

Ray 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 Practices."

GMPs cover wide range of plant manufacturing practices

In order to earn certification, companies must pass a stringent and thorough set of inspections by a third-party auditor. Program requirements include:

• Cleanliness and sanitation
• Personnel
• Facilities maintenance
• Quality control
• Production and process controls
• Warehousing and distribution

(See sidebar for details of NSF's requirements for GMP inspections.)

Looking ahead

Arrangements 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.

Quality 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.

NNFA and NSF International

NNFA (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.

Sources

NSF International. Draft Standard for Dietary supplements. Ann Arbor, MI: NSF International, Publication #NSF 173-2001, 9 July 2001.

Kathleen Pompliano, Business Development Manager, NSF International.

Tracy Taylor, Director of Communications, NNFA.