Shelf Life Dating of Botanical Supplement Ingredients and Products, a new guidance document from the American Herbal Products Association (AHPA), has recently been published and is available here for download. The document is free to AHPA members; non-member cost is $250.
The 36-page document, written by the AHPA Standards Committee and the AHPA Shelf Life Working Group, with Staci Eisner as the managing editor, explains the 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, the guidance document presents various strategies for meeting those requirements.
Although use of shelf-life dates is voluntary for dietary ingredients and dietary supplements sold in the United States, there are a number of important reasons--including liability reduction and a reduction in record-keeping regulations related to good manufacturing (cGMP) compliance--why a manufacturer would choose to include this information on its product labels.
Topics covered in this comprehensive document include:
· U.S. Regulations
· Shelf-Life Tests & Examinations
· Factors Affecting Shelf Life
· Sources of Shelf-Life Data
· Developing Shelf-Life Data
· Handling Shelf-Life Issues During an FDA Inspection
"This document is a useful addition to the resources available to industry supplement companies," noted AHPA President Michael McGuffin. "It will help companies understand the regulatory landscape related to shelf-life information as well as what is expected by the Food and Drug Administration from companies that choose to utilize this data on their labels."
Shelf Life Dating of Botanical Supplement Ingredients and Products 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.
About the American Herbal Products Association
The American Herbal Products Association is the national trade association for and the voice of the herbal products industry. AHPA is comprised of domestic and foreign companies doing business as growers, processors, manufacturers, and marketers of herbs and botanical and herbal products, including foods, dietary supplements, cosmetics, and non-prescription drugs. Founded in 1982, AHPA's mission is to promote the responsible commerce of herbal products. www.ahpa.org.