Stability Testing of Dietary Supplements – January 2011Page 2 of 26
The purpose of this guideline is to present recommendations for supporting the voluntaryshelf-life (expiration) dating claims of dietary supplements. Federal regulations do notrequire the use of dietary supplement product expiration dates. However, the FederalRegister GMP Preamble, June 25, 2007, Volume 72 Page, 34856 states, “the preambleto the 2003 cGMP Proposal emphasized that, if you use an expiration date on a product,you should have data to support that date (68 FR 12157 at 12204)”. For the purpose ofthis document, these recommendations also apply to dietary supplements thatvoluntarily claim “best by”, “use before”, etc. dates in lieu of a specific “expiration date.”This document is intended to provide practical guidance on what should be consideredwhen developing voluntary written shelf-life study protocols to establish or confirmexpiration dating of dietary supplements. It is written so as to leave sufficient flexibility toaddress the range of situations that may be encountered due to the specific scientificconsiderations and characteristics of the products and container-closure systems beingevaluated.For markets outside of the United States, applicable regulations from other countriesshould be followed. The initial draft of this guideline was developed based on the ICHGuidelines developed for conducting Stability Testing for Pharmaceutical products.
These guidelines are intended to be applicable to dietary supplements as defined andcovered by DSHEA and the United States Food and Drug Administration’s Code ofFederal Regulations Title 21, Part 111 [Current Good Manufacturing Practices inManufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements]