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NSF International

FDA Compliance

NSF Keeping Pace with FDA GMP Regulations

Published: Tuesday, May 27, 2008 - 21:00

(NSF International: Ann Arbor, Michigan) – 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 regulations.

The new version of NSF/ANSI Standard 173: Dietary Supplements contains revisions to Section 8 GMP requirements that reference the new FDA requirements for dietary supplement GMPs and 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 that they don’t contain undeclared ingredients or unacceptable levels of contaminants such as pesticides and heavy metals.

“NSF is committed to keeping its standards in line with key regulations such as FDA requirements for GMPs and AER,” says 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.

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.

“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,” says 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.”

For further information, visit www.nsf.org/business/newsroom/press_releases/press_release.asp?p_id=15993.

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NSF International

Manufacturers, regulators, and consumers look to NSF International for the development of public health standards and certification programs that help protect the world’s food, water, consumer products and environment. NSF’s mission is to protect and improve global human health. As an independent, accredited organization, its standards group facilitates the development of standards, and its service groups test and certify products and systems. NSF also provide auditing and risk management solutions for public health and the environment.