Federal regulations and dietary supplement Good Manufacturing Practices (GMPs) do not currently require expiration dating for nutritional supplements, but consumers have come to expect such information on products. Indeed, almost all dietary supplement products voluntarily use an expiration date on their labels.
However, a gap has existed whereby there has not previously been a recognized industry guideline specifically for dietary supplements that manufacturers can utilize to help develop their own internal stability testing programs.
NSF’s the new Stability Testing Guideline outlines the science-based criteria necessary to support expiration dating in order to comply with the current Good Manufacturing Practices (GMP) for dietary supplements.
“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, NSF-DBA Group Leader. “Dietary supplement companies can be proactive and use this guideline to ensure their expiration dates are backed by sound science.”
The 26-page document, available here, covers the various aspects of establishing the expiration date of a product, including the general principles of shelf-life studies, types of testing, and information on container-closure systems. In addition, the document provides information on the types of tests available to support shelf-life dating claims, including accelerated studies and long-term studies.
The guideline advises supplement manufacturers to identify the physical, chemical and microbiological characteristics of their products under long-term storage, and that stability testing ideally be conducted in the same container used for marketing the nutritional supplement product.
The guideline was welcomed by the Council for Responsible Nutrition (CRN), which described it as an industry stakeholder-driven and transparent initiative.
“While expiration dates are not required under GMPs, retailers generally require it and consumers expect it,” said Andrew Shao, PhD, senior vice president, scientific and regulatory affairs, CRN, and member of the Stability Testing Working Group. “Firms should use science-based evidence to determine their product’s stability and this guideline can help direct industry on how to do so.
“Moreover, FDA officials have made it clear that if expiration dates are used, adequate stability testing data is expected and that they will pay attention to it during inspections, so firms should really do their due diligence to make sure their expiration dates are backed by science,” added Dr Shao.