USP urges supplement manufacturers and regulators to voluntarily adopt public quality standards


USP responds to an agreement announced between the New York State Attorney General and GNC Holdings

In response to an agreement announced between the New York State Attorney General (NYAG) and GNC Holdings, Inc. (GNC) the United States Pharmacopeial Convention (USP), an independent, science-based standards setting organization and publishers of the United States Pharmacopeia-National Formulary (USP-NF), an official compendia of quality standards for dietary supplements sold in the US, issued the following statement:

Statement by Nandakumara Sarma, PhD, RPh, Director of Dietary Supplement Standards, United States Pharmacopeial Convention (USP): 'At USP, our mission is to improve global health through quality standards, so any agreement designed to ensure the quality of herbal supplement products is laudable and we are glad that the NYAG and GNC identified USP as a resource that can help with those efforts.'

'We applaud the emphasis on increased transparency and would like to point to public standards as a way to achieve that goal. The quality standards of the United States Pharmacopeia-National Formulary (USP-NF) are publicly available for any manufacturer to voluntarily adopt and for any regulator to reference as a way to ensure product quality.'

'We believe that public health is best served when both industry and regulators utilize the public quality standards of the USP-NF.'

'Although there are many sources for quality standards, USP’s public standards (to date about 500 for dietary ingredients and dietary supplements alone) are science-based and developed in a transparent process that reflects the input of a wide range of stakeholders. Our standards are developed with the guidance of volunteer experts from regulators (like the FDA, USDA and State Boards of Pharmacy), manufacturers as well as healthcare practitioners, academia and consumer groups.'

'We invite all interested parties to participate in our ongoing efforts to create public standards either by becoming a member of the USP Convention, by volunteering as an expert or by participating in the open public comment process. This process is designed to create uniform public standards that contribute to consistency in product quality and establish what test methods are appropriate for determining that quality exists.'

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And as the USP-NF are 'official compendia' for quality standards in the United States, they are a useful resource for manufacturers looking to ensure they meet federal requirements for Good Manufacturing Practices.'