Statement by GabrielGiancaspro, PhD – Vice President – Foods, Dietary Supplements and HerbalMedicines, United States Pharmacopeial Convention (USP)
“In recent weeks, the case ofsupplements containing an amphetamine-like substance called BMPEAhas prompted FDA recalls; industry trade group condemnation; appeals fromCongress for increased enforcement, consumer education campaigns and greaterparticipation by manufacturers in third-party verification programs; andhas been the subject of multiple media reports including a report by HBOthat focused on the use of these products by military personnel. There is wideagreement: these products pose a significant threat to public health and shouldnot be on the market.
To protect public health we dependon a safety net that relies on the coordinated efforts of multiple actors eachcontributing in different ways. Agencies as diverse as the Food and DrugAdministration (FDA); the Federal Trade Commission (FTC); the U.S. Departmentof Agriculture (USDA); Health and Human Services (HHS) and Customs and BorderProtection enforce a wide array of regulatory requirements that together makeup this protective net. Their work is complemented by academic researchers,industry and science-based nonprofits like the United States PharmacopeialConvention (USP).
When widely utilized by bothregulators and manufacturers, scientifically-based, public quality standards,like those in the UnitedStates Pharmacopeia-National Formulary (USP-NF) protect publichealth by promoting consistent quality regardless of where a product is made orby whom – an important feature in today’s increasingly global and complexsupply chain. USP standards are designed to be periodically updated toincorporate new technologies and reflect market trends – including theincreasingly sophisticated adulteration employed by criminals with the intentto obtain economic gain or others seeking to skirt regulatory requirements.
USP is in the process of developingnew standards that specifically address this issue. Proposed General Chapter <2251> Adulteration ofDietary Supplements with Drugs and Drug Analogs wasdeveloped with the input of regulators, industry and healthcare practitionersand is currently open for public comment. USP encourages all interested partiesto contribute their perspectives and expertise.
To further protect public health,USP established the “USPVerified” program for supplementmanufacturers and retailers seeking a more visible way to inform and reassureconsumers that their products consistently meet USP’s stringent qualitystandards.
Application of USP standards –either independently or via the USP Verified Program – can helpidentify adulterants and prevent questionable products from reaching consumers.Protecting public healthis a shared responsibility. That is why, at USP, we believe public health isbest served when both industry and regulators utilize the public qualitystandards of the USP-NF.