Dietary Supplement And Nonprescription Drug Consumer Protection Act

DIETARY SUPPLEMENT AND NONPRESCRIPTION DRUG CONSUMER PROTECTION ACT -- (House of Representatives - December 08, 2006)

BREAK IN TRANSCRIPT

Mr. PALLONE. Mr. Speaker, I yield myself such time as I may consume.

Mr. Speaker, I rise in support of S. 3546, the Dietary Supplement and Nonprescription Drug Consumer Protection Act. By some estimates, the dietary supplement industry is a $20 billion industry. Over half the American population regularly uses dietary supplements, with as many as 60 percent of Americans using dietary supplements daily in an effort to maintain or improve their healthy lifestyles.

Many responsible dietary supplement companies and manufacturers already voluntarily report serious adverse events associated with their products to the FDA. However, in order to ensure the safety of consumers, all companies should be required by law to report such events. This bill accomplishes that goal.

The legislation before us today would amend the Food, Drug, and Cosmetic Act to require that the manufacturer, packer or distributor of a dietary supplement or over-the-counter drug notify the FDA within 15 business days of any serious adverse event reports it receives that are associated with one of their dietary supplements or over-the-counter products.

A serious adverse event is described as a health-related event that results in death, a life-threatening experience, in-patient hospitalization, a persistent or significant disability or incapacity, or congenital anomaly or birth defect.

Adverse event reports provide an early warning signal to the FDA about potential product problems, like product contamination or adulteration, tampering, bioterrorism and ingredient safety issues. By requiring that this information be submitted to a single source, manufacturers increase the likelihood that problems will be identified more quickly and fewer consumers will be affected.

Although the FDA currently receives adverse event reports from consumers, health care providers, poison control centers and even many manufacturers on a voluntary basis, this legislation will ensure that a greater number of serious adverse event reports are transmitted to the FDA for review.

Consumers should be assured that when a serious incident happens, the manufacturer will be held responsible for informing the Federal agency that regulates these products. Adverse event reporting by the manufacturer is already required for other FDA regulated products, such as medical devices, prescription drugs and certain over-the-counter-drugs. It is time that we require the same reporting standards for dietary supplements, and this change will help protect consumers and build greater confidence in the safety of dietary supplements.

Again, I would like to thank Senators HATCH, HARKIN and DURBIN, as well as all the industry and consumer groups who worked hard on developing this legislation, and I urge my colleagues to join me in supporting it.

BREAK IN TRANSCRIPT

http://thomas.loc.gov/