Dietary Supplement and Nonprescription Drug Consumer Protection Act

Townsend Letter for Doctors and Patients,  May, 2007  by Jule Klotter

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On December 22, 2006, President Bush signed into law the Dietary Supplement and Nonprescription Drug Consumer Protection Act (Public Law No: 109-462). This law requires each nonprescription drug and dietary supplement, sold in the US, to have the manufacturer's or retailer's domestic address or phone number on its label, so that consumers can report serious adverse events that occur while taking the substance. A serious adverse event is defined as a life-threatening event that results in death, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, or a circumstance that requires medical or surgical intervention to prevent one of these outcomes.

Companies are responsible for submitting reports of a serious adverse effect to the Secretary of Health and Human Services within 15 business days. They must also submit subsequent, related medical information, received within one year of the event. The Secretary is responsible for developing systems that consolidate duplicate reports and medical information concerning an event into one report. Companies are required to keep records pertaining to each reported adverse event for six years and to allow inspection by Department of Health and Human Services employees. "The submission of any adverse event report ... shall not be construed as an admission that the nonprescription drug [or dietary supplement] involved cause or contributed to the adverse event," according to the new law.

A bill to amend the Federal Food, Drug, and Cosmetic Act with respect to serious adverse event reporting for dietary supplements and nonprescription drugs, and for other purposes. Available at http://thomas.loc.gov/cgi-bin/bdquery/z?d109:SN03546:@@@L?summ2=m&. Accessed February 7, 2007.

COPYRIGHT 2007 The Townsend Letter Group
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