Published: Friday, July 1, 2011
This document provides an overview of federal regulations regarding the use of shelf
life dates for dietary ingredients and dietary supplements sold in the United States,
with a particular emphasis on botanical ingredients and products. In addition it
presents various strategies for meeting those requirements.
It is important to note at the outset that neither dietary ingredients nor dietary
supplements are required to be identified with shelf life dates; such that any such
dating is voluntary on the part of companies that market these products. At the same
time, when shelf life dating is used it should be supported by data, though individual
companies may decide what kind and how much data to use to support a stated shelf
This document is not intended as a detailed step-by-step guide to implementing a
shelf life or stability study. For that purpose the reader should contact an appropriate
expert such as a consultant or laboratory that conducts shelf life studies. While AHPA
believes that all of the information here is accurate, any company that chooses to use
this information is advised to discuss all aspects related to this subject matter with a
qualified consultant, an attorney or with relevant FDA staff.
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