Group unveils guideline for expiration dating of nutritional supplements

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.”