January 20, 2011
ANN ARBOR, Mich.NSF International helped create a new voluntary Stability Testing Guideline to help nutritional supplement companies make sure they have the necessary data to support expiration dates on product labels. The Council for Responsible Nutrition (CRN) said it supported the release of the new guideline, with Andrew Shao, senior vice president, scientific and regulatory affairs, CRN, saying it is, another example of an important supplement industry self-regulatory initiative."
The dietary supplement GMPs (good manufacturing practices) do not currently require expiration dating, but FDA regulations require scientifically valid data to support expiration dates included on product labels. While almost all dietary supplement products voluntarily use an expiration date on their labels, there is not currently a recognized industry guideline specifically for dietary supplements that manufacturers can utilize to help develop their own internal stability testing programs.
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 of manufacturing, packaging, labeling, distribution and holding/warehouse processes may have on a products stability. The guideline also proposes that stability testing be conducted in the same container used for marketing the nutritional supplement product. Factors involved in stability testing include: dietary ingredient strength, chemical fingerprints, microbial growth, preservative content, moisture content, pH, viscosity and oxidation, among other parameters such as the products container-closure system.
NSF-DBA, an NSF International Company, worked in conjunction with regulators and industry trade groups to coordinate the development of the new guideline, which outlines the science-based criteria necessary to support expiration dating in order to comply with the current GMPs 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 completed document, freely available to all industry stakeholders and currently housed on the NSF website, provides dietary supplement companies with recommendations on what they should consider when developing their voluntary written shelf-life study protocols to establish the expiration dates of their products. The guideline helps firms identify appropriate ways to gather stability testing data of their products.
While expiration dates are not required under GMPs, retailers generally require it and consumers expect it. Firms should use science-based evidence to determine their products stability and this guideline can help direct industry on how to do so," said Shao, who is also a Stability Testing Working Group member. 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."
You May Also Like