In response to a multi-agency sweep of dietary supplements that are unsafe, tainted and/or make unsubstantiated claims, 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 Ronald T. Piervincenzi, Ph.D. – Chief Executive Officer, United States Pharmacopeial Convention (USP)
“The United States Pharmacopeial Convention – a nearly 200 year old science based non-profit organization that sets quality standards for drugs, dietary supplements and food ingredients – agrees with the Department of Justice, Food and Drug Administration (FDA), Federal Trade Commission, Department of Defense and others that products marketed as dietary supplements, but which are tainted with illegal ingredients or which make unsubstantiated claims pose a significant threat to public health and should not be on the market. We applaud this collaborative multi-agency effort to protect public health.
We want to emphasize that USP is not in any way associated with the company called USPLabs which was subject to the enforcement actions. The contrast between our two organizations could not be greater. We find the confusion caused by their name unfortunate. At the request of our lawyers, USPLabs agreed to include a statement on their website confirming they are not affiliated with USP and its products are not endorsed by USP.
On the contrary, USP’s mission is to promote public health through public standards designed to help ensure the integrity of global supply chains and the quality and safety of products sold in the United States. USP standards are published in the United States Pharmacopeia-National Formulary (USP-NF) which is recognized in the 1938 Food Drug and Cosmetic Act, as "official compendia" and are enforceable by the FDA. Compliance with USP standards is mandatory for drugs sold in the U.S. and voluntary for dietary supplements.
As demonstrated by the collaborative efforts of the diverse federal agencies who participated in the sweep, public health depends on a safety net that relies on the coordinated efforts of multiple actors each contributing in different ways.
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 chains. 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 recently announced 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 one of many topics that will be addressed in an upcoming workshop devoted to the issue of Adulteration and Fraud in Dietary Supplements and Food Ingredients that will take place Dec. 3 – 4, 2015 at USP’s offices in Rockville, MD. Among the experts who will be presenting at the USP workshop are representatives from the FDA, the USDA, the Food Protection and Defense Institute (a Homeland Security Center of Excellence), Interpol, the International Olympic Committee and the New York Botanical Garden.
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 to which USP has been contributing for nearly 200 years. 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.”