In response to multiple actions regarding dietary supplements containing drugs or drug analogs, the United States Pharmacopeial Convention (USP), an independent, science-based, standards-setting organization and publisher of the United States Pharmacopeia-National Formulary (USP-NF), an official compendia of quality standards for dietary supplements sold in the U.S., issued the following statement:
Statement by Gabriel Giancaspro, Ph.D., vice president of foods, dietary supplements and herbal medicines, United States Pharmacopeial Convention (USP):
“In recent weeks, the case of supplements containing an amphetamine-like substance called BMPEA has prompted FDA recalls; industry trade group condemnation; appeals from Congress for increased enforcement, consumer education campaigns and greater participation by manufacturers in third-party verification programs; and has been the subject of multiple media reports including a report by HBO that focused on the use of these products by military personnel. There is wide agreement: These products pose a significant threat to public health and should not be on the market.
“To protect public health we depend on a safety net that relies on the coordinated efforts of multiple actors each contributing in different ways. Agencies as diverse as the Food and Drug Administration (FDA); the Federal Trade Commission (FTC); the U.S. Department of Agriculture (USDA); Health and Human Services (HHS) and Customs and Border Protection enforce a wide array of regulatory requirements that together make up this protective net. Their work is complemented by academic researchers, industry and science-based nonprofits like the United States Pharmacopeial Convention (USP).
“When widely utilized by both regulators and manufacturers, scientifically based, public quality standards, like those in the United States Pharmacopeia-National Formulary (USP-NF) protect public health by promoting consistent quality regardless of where a product is made or by whom—an important feature in today’s increasingly global and complex supply chain. USP standards are designed to be periodically updated to incorporate new technologies and reflect market trends—including the increasingly sophisticated adulteration employed by criminals with the intent to obtain economic gain or others seeking to skirt regulatory requirements.
“USP is in the process of developing new standards that specifically address this issue. Proposed General Chapter <2251> Adulteration of Dietary Supplements with Drugs and Drug Analogs was developed with the input of regulators, industry and healthcare practitioners and is currently open for public comment. USP encourages all interested parties to contribute their perspectives and expertise.
“To further protect public health, USP established the USP Verified program for supplement manufacturers and retailers seeking a more visible way to inform and reassure consumers that their products consistently meet USP’s stringent quality standards.
“Application of USP standards—either independently or via the USP Verified Program—can help identify adulterants and prevent questionable products from reaching consumers. Protecting public health is a shared responsibility. That is why, at USP, we believe public health is best served when both industry and regulators utilize the public quality standards of the USP-NF.”