CHPA Hails Senate Passage of S. 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act

Washington, D.C. (December 7, 2006)—The following is a statement from Linda A. Suydam, D.P.A., president, Consumer Healthcare Products Association (CHPA), in support of Senate passage of legislation requiring mandatory reporting to the U.S. Food and Drug Administration of serious adverse events associated with over-the-counter (OTC) medicines and nutritional supplements.

"CHPA commends Senators Hatch (R-Utah), Harkin (D-Iowa), Durbin (D-Ill.), Enzi (R-Wyo.), and Kennedy (D-Mass.) on developing and introducing S. 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act.

"CHPA has long been an advocate of mandatory reporting of serious adverse events to FDA for all OTC medicines and nutritional supplements. Manufacturers of many OTC drugs are already required to report serious adverse events to the Agency. This legislation would codify this procedure for all drugs and extend the practice to dietary supplements. This legislation, if passed, will ensure FDA has the tools it needs to fulfill its public health mission to more aggressively monitor the medicines and nutritional supplements it regulates.

"For the benefit of all consumers, we urge Congress to move this legislation forward swiftly."

Editor’s note: S. 3546 now moves to the U.S. House of Representatives for consideration. If passed into law, this legislation would align monographed OTCs and nutritional supplements with the adverse event reporting requirements already present for OTC medicines under New Drug Applications.

Contacts: Elizabeth Assey and Virginia Cox, 202.429.9260


CHPA is the 125-year-old trade association representing U.S. manufacturers and distributors of over-the-counter medicines and nutritional supplements.