10.10.11
The American Herbal Products Association (AHPA) has published “Shelf Life Dating of Botanical Supplement Ingredients and Products,” a new guidance document available 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 U.S., 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 U.S., there are a number of important reasons—including liability reduction and a reduction in record-keeping regulations related to good manufacturing (GMP) 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 and Handling Shelf-Life Issues During an FDA Inspection. For further information: www.ahpa.org