NSF's Dietary Supplement Standard is Updated to Keep Pace with FDA GMP Regulations

NSF/ANSI Standard 173:2008 is Published

Ann Arbor, MI – NSF International today announced that the 2008 version of NSF's American National Standard for Dietary Supplements now includes new good manufacturing practices (GMP) requirements to ensure consistency with the U. S. Food and Drug Administration's (FDA) regulations. These changes will take effect June 25, 2008 for companies who employ more than 500 employees; companies with less than 500 employees will have additional time.

The new version of NSF/ANSI Standard 173: Dietary Supplements contains revisions to Section 8 GMP requirements that reference the new FDA requirements for both dietary supplement GMPs, as well as the Adverse Event Reporting (AER) requirements that went into effect in December 2007. The NSF American National Standard is used to evaluate and analyze dietary supplements to ensure they do not contain undeclared ingredients or unacceptable levels of contaminants such as pesticides and heavy metals.

Businesses that employ 500 or more employees must be compliant with these new requirements by June 25, 2008. Businesses that employ less than 500, but 20 or more must be compliant by June 25, 2009, and businesses that employ fewer than 20 employees must be compliant by June 25, 2010. Companies being audited for GMP compliance under NSF/ANSI Standard 173 are also expected to meet the compliance dates set forth by the FDA.

“NSF is committed to keeping its standards in line with key regulations such as FDA requirements for GMPs and AER,” said Jane Wilson, NSF Director of Standards. “That is why NSF/ANSI Standards are continuously being reviewed and updated to ensure that they are consistent with new legislation and the latest technical developments.”

These updates will also be incorporated into NSF's Dietary Supplement Certification Program, which is based on NSF/ANSI Standard 173. Certification of products to this standard provides consumers confidence that what is on the label matches what is in the product. Certification also ensures that dietary supplements are produced in accordance with GMPs and are certified free of harmful contaminants.

"These requirements verify that manufacturers are in compliance, enable regulators to rely on independent certification, and help consumers make informed decisions when choosing a supplement with the NSF Mark," said Kristen Holt, Senior Vice President, NSF Dietary Supplements Programs. “The NSF Mark on a product demonstrates that the product has met and will continue to meet all program requirements.”

To date, the NSF Dietary Supplement Certification Program has issued nearly 400 certifications of products that are sold worldwide. Products certified to NSF/ANSI Standard 173 are listed on the NSF website.

Background on the Standard
NSF/ANSI 173 provides criteria and evaluation methods to ensure that dietary supplement products contain the identity and quantity of ingredients listed on product labels, and that the products are free of any undeclared contaminants. The standard also provides criteria to determine conformance to GMPs. NSF/ANSI 173 was developed through American National Standards Institute's (ANSI) accredited development process with participation from the dietary supplements industry, public health regulators and distributors of dietary supplements.

For more information on NSF's Dietary Supplements Programs, please visit NSF's dietary supplement webpage or contact Edward Wyszumiala, General Manager of NSF's Dietary Supplements at 734-913-5706 or [email protected].

About NSF International: NSF International, an independent, not-for-profit organization, helps protect you by certifying products and writing standards for food, water and consumer goods (www.nsf.org). Founded in 1944, NSF is committed to protecting public health and safety worldwide. NSF is a World Health Organization Collaborating Centre for Food and Water Safety and Indoor Environment. Additional services include safety audits for the food and water industries, management systems registrations delivered through NSF International Strategic Registrations, organic certification provided by Quality Assurance International and education through the NSF Center for Public Health Education.

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