Guidance on shelf life dating of botanical supplement ingredients and products

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Guidance on shelf life dating of botanical supplement ingredients and products

Overview of federal regulations and compliance strategies

Author: Haley (Admin)/Friday, July 1, 2011/Categories: Legal Alert, Front Page, HP-Education, Bookstore, Publications, Resources, Guidance Documents

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 life date.

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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