国防授权法案修正案将通过确保营养品质量来保护军队卫生

2015-09-16 21:31:16.0

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

2015-09-15 17:44:15.0

Statement by Jaap Venema – ChiefScience Officer, United States Pharmacopeial Convention

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

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

The United States PharmacopeialConvention strongly supports public standards and verification programs as away to help protect all service members at home and around the world, as wellas consumers in general.  We believe that public health is best servedwhen both industry and regulators utilize the public quality standards of the USP-NFand we encourage supplement manufacturers to utilize USP public standards,either independently or via the USP Verification Program.

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

The quality standards of the UnitedStates Pharmacopeia-National Formulary (USP-NF) were firstrecognized by Congress in the 1906 Food, Drugs and Cosmetics Act (FD&C) as“official compendia” of quality standards for products sold in the UnitedStates. 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 lateramendment made them voluntary for supplements.

We invite all interestedparties to participate in our on-going efforts to create public standardseither by becoming a member of the USP Convention, by volunteering as an expertor by participating in the open public comment process.  USP is in theprocess 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.