The guideline could be a widely-accepted standard for validation of expiration date labels.
Current Good Manufacturing Practices (GMPs) don't require the use of expiration dates on dietary supplement product labels, but FDA is going to look for scientific validation if such labels are used. Currently, there is no universal testing method recognized by industry for validating expiration dates.
An industry working group, including the Council for Responsible Nutrition (CRN; Washington, DC), has now developed a guideline for standardized scientific testing to support expiration dates on product labels.
Representatives from FDA and the NIH Office of Dietary Supplements oversaw the working group during its creation of the new guidelines.
“While expiration dates are not required under GMPs, retailers generally require it and consumers expect it,” said Andrew Shao, senior vice president of scientific and regulatory affairs for CRN. “Firms should use science-based evidence to determine their product’s stability and this guideline can help direct industry on how to do so.”
Beyond retailers and consumers, the mood suggests that FDA has been cracking down on expiration date validation.
“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 of NSF-DBA (Ann Arbor, MI), which worked with the working group to develop the guideline. “Dietary supplement companies can be proactive and use this guideline to ensure their expiration dates are backed by sound science.”
Check out NSF-DBA's website for access to dietary supplement expiration date guidelines.