Dietary supplements are regulated by the FDA per 21 CFR 111. They are not approved by the FDA, meaning that the regulatory role begins once products have entered the marketplace. In general, the supplement industry is most self-regulated, meaning that supplements can be sold without any independent verification to what is inside the container.
What is the NSF?
Founded in 1944, the National Sanitation Foundation (NSF) works as an independent, internationally recognized organization to ensure the development of vigorous public health standards. The NSF works to test, audit and certify a wide range of products and services to these standards. The NSF mark is widely recognized at the ‘gold standard’ for quality in areas including food safety and health sciences.
NSF/ANSI 455 – Good Manufacturing Practices for Dietary Supplements, Cosmetics and OTC drugs
Current Good Manufacturing Practices (cGMP) provide a standard that a manufacturing facility operates in accordance with specific, strict quality standards.
NSF/ANSI 455 provides for the GMP standards for; dietary supplements (455-2), cosmetics (455-3) and OTC drugs (455-4).
Facilities must be re-certified on an annual or bi-annual basis. The process to become certified involves the following:
- Quality management – looking at the facility’s standard operating procedures (SOPs), record keeping and more
- Facility and equipment – an in-person inspection to verify that the facility is sanitary and well-maintained
- Traceability – an audit verifying that there is a clear and stringent process for tracking of raw materials through to the finished product
Manufacturing companies with NSF/ANSI 455-2 certification or registration get instant eligibility to enter products into NSF’s product certification program – NSF/ANSI 173.
NSF/ANSI 173
This NSF/ANSI 173 is the only American National Standard for testing and certifying nutritional supplements. It lays out what is meant by a dietary supplement, namely that it is a product that is intended to supplement the diet and includes one or more of the following dietary ingredients: a vitamin, a mineral, an herb or other botanical, or an amino acid.
NSF/ANSI 173 provides strict test methods and evaluation criteria that a dietary supplement must be tested against to verify it contains the ingredients claimed on the label and that it does not contain undeclared contaminants. It also ensures that current Good Manufacturing Practices (cGMP) were followed during the production of the dietary supplement.
The standard ensures that supplements contain what is listed on the label and are free from contaminants.
The requirements for products evaluated under NSF/ANSI 173 include:
- Label claim verification – that the product contains the ingredients listed at the quantities stated
- Contaminant screening – products are tested for toxic elements, microbiological contaminants, pesticides and mycotoxins.
- Good Manufacturing Practices compliance – cGMP is being adhered to, including documentation review, equipment and personnel training and batch release procedures.
Products that have been evaluated against NSF/ANSI 173 will display an NSF Contents Certified mark, meaning that customers can be sure that the product they plan to consume has been tested to rigorous standards.
In conclusion
In short – NSF/ANSI 173 focuses on product testing, labeling and ingredient verification. NSF/ANSI 455 focuses on cGMP compliance, manufacturing practices and facility audits.
Mineralife Nutraceutical’s NSF/ANSI 455-2 certification is an indication to our current and future customers that we have facilities, equipment, standard operating procedures, and quality controls in place to ensure that high-quality dietary supplements are being manufactured here in Colorado Springs, CO. To work with us get in touch here.