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The guidance document explains federal regulations for the use of shelf-life dates for U.S. dietary ingredients and supplements.
The American Herbal Products Association (AHPA; Silver Spring, MD) has published a new 36-page guidance document titled “Shelf Life Dating of Botanical Supplement Ingredients and Products.” The guidance is available free to AHPA members or can be purchased for $250 by non-members.
The guidance document was written by AHPA’s Standards Committee and the association’s Shelf Life Working Group and explains federal regulations for the use of shelf-life dates for dietary ingredients and dietary supplements sold in the United States.
Currently, shelf-life dating is voluntary for dietary ingredients and supplements sold in the United States; however, for reasons such as liability reduction, companies often include shelf-life information on product labels.
The guidance document covers topics such as factors that can affect shelf life, developing shelf-life data, and handling shelf-life issues during a FDA inspection.
“It will help companies understand the regulatory landscape related to shelf-life information as well as what is expected by the FDA from companies that choose to utilize this data on their labels,” stated AHPA president Michael McGuffin, in a press release.