As an organization that provides, among other services, product certification and facility registrations, we find that not all companies understand the crucial differences between product certification and facility registration. This article will help those in the dietary supplement industry understand the differences between NSF International’s programs and how these programs are used in the marketplace.
Simply put, product certification means that NSF International has tested and certified a dietary supplement product to meet specific safety and quality requirements; thus, NSF International’s Dietary Supplement and Certified for Sport product certification programs apply to a finished product.
By contrast, facility registration involves on-site audits of a company’s entire production operation. These audits verify that a facility has the proper methods, equipment, facilities, and controls in place to produce safe, high-quality products in accordance with federal regulations; hence, NSF International’s Good Manufacturing Practices (GMP) and GMP for Sport registrations apply to the dietary supplement manufacturing facility.
As the GMP and GMP for Sport facility registrations, and the Dietary Supplement and Certified for Sport product certification programs, continue to grow, so have opportunities for confusion around the use and misuse of the NSF logo, and verbiage on product labels and in marketing materials.
NSF’s GMP and GMP for Sport programs were developed in 2002 in accordance with FDA 21 CFR Part 111 regulations for the manufacturing, packaging, and distribution of dietary supplements. Earning GMP registration from NSF International verifies that a dietary supplement manufacturing facility has the proper methods, equipment, facilities, and controls in place for producing dietary supplements in accordance with NSF guidelines and federal regulations. The GMP for Sport registration program takes this a step further by verifying that a manufacturing facility has additional sourcing and tracing capabilities in place to prevent product cross-contamination.
It’s important to note that GMP registration does not include product testing or certification; therefore, companies with just NSF GMP registration are not permitted to use the NSF certification mark on product labels, nor may their product labels contain language stating that a product was made in an NSF GMP or NSF GMP for Sport facility.
GMP facility registration is one step towards product certification, but it is not product certification.
Launched in 2001, the NSF Dietary Supplement Certification Program is based on the only American National Standard (American National Standards Institute) for dietary supplements, NSF/ANSI 173. It was developed through a consensus process including input from a diverse group of industry, consumer, academic, and regulatory stakeholder groups. The NSF Dietary Supplement Certification process requires:
- Label-claim testing to certify that what is claimed on a product label is in the product.
- Toxicology review to certify a product’s formulation. (NSF, however, does not test products for efficacy.)
- Contaminant testing to ensure there are no undeclared ingredients or unacceptable levels of contaminants present in the product.
- Semiannual GMP facility audits of the production plant.
- Ongoing monitoring to certify compliance through periodic auditing and testing.
The NSF Certified for Sport program takes the Dietary Supplement Certification program a step further by testing products for more than 180 banned substances on the World Anti-Doping Agency’s list, as well as the National Football League, Major League Baseball, and National Collegiate Athletic Association prohibited-substances lists.
Only products that NSF tests and certifies may utilize the NSF certification mark or name on product labels. Additionally, marketing collateral such as websites, brochures, inserts, and advertisements that refer to NSF product certification must also clearly state the specific certified product name and, in the case of the Certified for Sport program, the lot number or SKU that NSF International tested and certified.