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NSF amends supplement standards ahead of FDA deadlines

By Neil Merrett, 09-May-2008

Leading US third party certifier NSF has updated its national standards on Good Manufacturing Practices (GMP) for dietary supplement production, ahead of soon to be enforced revisions to quality standards within the industry.

The company says that it has amended its NSF/ANSI Standard 173 to bring it in compliance with both the new GMP and the Adverse Event Reporting (AER) requirements that came into place back in December last year.

To ensure continued consumer faith within the group's third party certification, NSF says that it has tightened its definitions on acceptable manufacturing standards to ensure that what is on a label matches the product inside.

FDA rules

This is particularly important to ensure against the presence of pesticides and heavy metals entering into the products. The latest revisions, which have been continuously updated in recent years, will put the NSF standards in line with new Food and Drug Administration (FDA) rules regarding supplement production that come into place next month.

By June 25, manufacturers with more than 500 employers will have to ensure their processing operations are up to GMP standards. Smaller manufacturers will be granted additional deadlines to bring their operations in line with the requirements.

As a result of these extensions, manufacturers with between 20 to 500 employers will have an additional year to comply with the regulations, while a final deadline of 2010 is set for companies with less than 20 workers.

GMP regulations

A statute of the 1994 Dietary Supplements Health and Education Act (DSHEA ), GMP legislation has been the missing link in governance of the dietary supplement industry. The legislation is set to provide standards specific to the dietary supplements industry for inspectors to check for purity, safety and legality in manufacturing.

The rule applies to companies - domestic and foreign alike - that manufacture, package, label, store and distribute dietary supplements in the US.

Kristen Holt, NSF senior vice president for dietary supplement, claims the changes will ensure that any products now bearing the new certification standards would guarantee a product is free from potentially 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," she stated. "The NSF Mark on a product demonstrates that the product has met and will continue to meet all program requirements."