Group unveils guideline for expiration dating of nutritional supplements

January 29, 2011

A group of regulatory, industry, and consumer groups has created a new

voluntary guideline to ensure that nutritional supplement companies have the

necessary data to support expiration dating on product labels.

NSF-DBA, a provider of pharmaceutical training, consulting, and testing

services, worked with the groups to coordinate the development of the new

Stability Testing Guideline. The guideline outlines the science-based

criteria necessary to support expiration dating in order to comply with

current good-manufacturing practices (GMP) for dietary supplements.

The guideline suggests that nutritional supplement companies identify the

physical, chemical, and microbiological characteristics under long-term

storage. It specifies that companies understand the impact that

manufacturing, packaging, labeling, distribution, and holding/warehouse

processes may have on a product’s stability. Factors involved in stability

testing include strength of dietary ingredients, chemical fingerprints,

microbial growth, preservative content, moisture content, pH, viscosity, and

oxidation.

“If expiration dates or voluntary claims such as ‘best by’ or ‘use before’

appear on a nutritional supplement label, FDA officials expect supporting

stability test data to be available, and they will look for this information

during GMP inspections,” said Casey Coy, group leader of NSF-DBA. “Dietary

supplement companies can be proactive and use this guideline to ensure their

expiration dates are backed by sound science.”

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Ortiz, MS, RD

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