Proposed Amendment to the National Defense Authorization Act Would Protect Military Health by Ensuring Supplement Quality

PRESS RELEASE

(Rockville, MD — June 3, 2015) — In response to a proposed Senate amendment to the National Defense Authorization Act that would foster the use of independent third party certification in supplements purchased on military bases, the United States Pharmacopeial Convention (USP), an independent, science based, non-governmental, public 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 U.S., issued the following statement:

Statement by Jaap Venema — Chief Science Officer, United States Pharmacopeial Convention

“Today, an amendment was introduced on the Senate floor that proposes to protect the health of U.S. military personnel by limiting dietary supplements sold on U.S. military installations to those whose quality has been verified by an independent third party.

The amendment extends an existing policy established years ago by the Department of Defense (DoD) in the wake of adverse events, including fatalities, believed to be caused by dietary supplements that were tainted with drugs or drug analogs. The current policy limits certain supplements, sold in military commissaries, to those that have been verified for quality by an independent third party, including USP. The proposed amendment extends that policy to supplements sold on U.S. military installations — whether in commissaries, exchanges or retail stores.

The United States Pharmacopeial Convention strongly supports public standards and verification programs as a way to help protect all service members at home and around the world, as well as consumers in general. We believe that public health is best served when both industry and regulators utilize the public quality standards of the USP-NF and we encourage supplement manufacturers to utilize USP public standards, either independently or via the USP Verification Program.

We are proud that DoD looked to the USP Verified program as one way to protect the health of America’s military personnel, many of whom are known to be committed users of dietary supplements in their efforts to ensure physical fitness and military readiness. Unfortunately, military personnel are also believed to be at greater risk for adverse reactions to dietary supplements as the result of operational environments and stressors (extreme heat, altitude, sleep deprivation, etc.) common in military deployments and training.

The quality standards of the United States Pharmacopeia-National Formulary (USP-NF) were first recognized by Congress in the 1906 Food, Drugs and Cosmetics Act (FD&C) as “official compendia” of quality standards for products sold in the United States. Public standards help ensure the quality and consistency of medicinal products. FD&C made USP-NF standards mandatory for drugs sold in the US. A later amendment made them voluntary for supplements.

We invite all interested parties to participate in our on-going 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. 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 is currently open for public comment.