Background

Although federal regulations do not require the use of dietary supplement product expiration dates, most, if not all products include some kind of expiration or use-by date. In addition, the preamble to the current Dietary Supplement GMPs 21 CFR 111 requires that companies manufacturing and selling dietary supplements with product expiration dates should justify these with " ...data that qualifies the stability of the products and container closure systems."

In the fall of 2009, a stability working group was established to develop a voluntary guideline for industry to assist with the development of stability programs consisting of shelf-life studies. These stability studies can provide justification for the establishment of expiration dating on dietary supplement finished products. The working group was comprised of representatives from various industry stakeholders including major trade associations, dietary supplement manufacturers and analytical laboratories, with FDA serving as an observer to the process.

Working Group Members

View a list of our working group members and their affiliations.