The American Herbal Products Association (AHPA) submitted comments to the United States Pharmacopeia (USP) in response to a new proposed USP General Chapter <2251> (USP <2251>), titled "Adulteration of dietary supplements with drugs and drug analogs." USP <2251> is designed to provide analytical methodologies for detection of product adulteration with synthetic compounds.
AHPA's comments express significant concern that the title of USP <2251>, the repeated reference to dietary supplements throughout the chapter, and the intended placement of the general chapter in USP's Dietary Supplement Chapters strongly imply that products containing undeclared drugs or drug analogs are dietary supplements. They are not. Instead, these products are unlawful, misbranded drugs.
AHPA stresses that the products described in USP <2251> are misbranded drugs and using any other term to identify these products only creates confusion. Unlawful products adulterated with drugs and drug analogs are sometimes falsely labeled and marketed as dietary supplements, but this doesn't change the fact that these products are misbranded drugs.
AHPA notes that this terminology is consistent with the U.S. Department of Justice and the Food and Drug Administration (FDA) which also refer to these products as misbranded drugs in various enforcement actions.
"USP has long recognized the importance of precision and accuracy in the titles and nomenclature used within its monographs. This same specificity must be applied here," said Tami Wahl, AHPA's Special Regulatory Council. "This level of accuracy is imperative to avoid fostering misconceptions about dietary supplements."
In order to make the USP <2251> more precise and accurate, AHPA recommends changing the title of USP <2251>, removing "dietary supplement" references from the text of the general chapter, and not including USP <2251> in the Dietary Supplement Chapters.
Background
Comprehensive federal laws and regulations prohibit dietary supplement manufacturers and distributors from marketing products that are adulterated or misbranded. Products that are not manufactured in compliance with strict, current good manufacturing practice (cGMP) requirements or fail to list each ingredient in the product on the label are considered adulterated or misbranded. In addition, federal law mandates that dietary supplement manufacturers only use lawful dietary ingredients in their products and prohibits the inclusion of drugs and drug analogs.
AHPA and the regulated dietary supplement industry work to inform consumers about misbranded drugs falsely labeled and marketed as dietary supplements through the website KeepSupplementsClean.org.