[20070123]RS22480_《膳食补充剂和非处方药消费者保护法》（P.L109-462).pdf

1 U.S. Congress, Senate Committee on Health, Education, Labor and Pensions, DietarySupplement and Nonprescription Drug Consumer Protection Act, report to accompany S. 3546,109th Cong., 2nd sess., S.Rept. 109-324 (Washington: GPO, 2006).2 The terms nonprescription and over-the-counter (OTC) drugs will be used interchangeably inthis report. Order Code RS22480Updated January 23, 2007Dietary Supplement and NonprescriptionDrug Consumer Protection Act (P.L.109-462)Donna V. PorterSpecialist in Life SciencesDomestic Social Policy DivisionSummaryA bipartisan bill, the Dietary Supplement and Nonprescription Drug ConsumerProtection Act (S. 3546) was introduced on June 21, 2006, and became law (P.L.109-462) on December 22, 2006. The law requires reports of serious adverse events to besubmitted to the Food and Drug Administration (FDA) by manufacturers of dietarysupplements and nonprescription drugs. Lawmakers were told of the limitations of dataon adverse events attributed to dietary supplements during hearings on the dietarysupplement ingredient ephedra held during several Congresses. This report providesbackground information on P.L.109-462 and summarizes its provisions. It will beupdated as