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 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.
AHPA Member Price: FREE (AHPA Members Log In to download this document below)
Non-Member Price: $250.00
The Botanical Safety Handbook, Second Edition includes:
- Easily understood classification systems to indicate the safety of each listed species and the potential for drug interactions
- Information on adverse events reported in clinical trials or case reports
- Safety-related pharmacology and pharmacokinetics of each herb
- Additional information on the use of herbs by pregnant or lactating women
- Toxicological studies and data on toxic compounds
- Extensive references for each entry
The book is available in hardback print and online formats. Both versions contain the same information, but the online version, which is optimized for smartphones and tablets, has several additional attributes. Some of these relate to its operation, as it allows subscribers to search for keywords and botanical names and easily access the information they use most by saving personalized lists of entries. Perhaps more importantly, the online version will be updated regularly with new research, and subscribers will be notified of updates to provide immediate access to the most current information. The standard retail cost for either version is $119.95 (one-time cost in print; a renewable annual subscription online). We are discounting the cost for our members and would be happy to offer a discount to other organizations. A free preview of several entries are available online:
Subscribe to the online version or purchase a hardcover copy today. AHPA's Botanical Safety Handbook, Second Edition Print Version: 1,042 pages, revised edition published in 2013 AHPA's Botanical Safety Handbook, Second Edition Online
Member annual subscription: $95.00
Non-member annual subscription: $119.00 Discounts available for multiple user subscriptions.