Bonnie Applauds Dietary Supplement Adverse Events Bill

Northbrook, IL December 8, 2006 - Licensed Dietitian Nutritionist Bonnie Minsky was thrilled to see the United States Senate pass the Dietary Supplement and Nonprescription Drug Consumer Protection Act, S. 3546. Introduced by Senator's Orrin Hatch (R-UT) and Richard Durbin (D-IL), S.3546 establishes a requirement for marketers of dietary supplements and OTC drugs to inform the FDA if they receive reports of serious adverse events associated with their products. The bill will need to be considered in the House of Representatives (the companion bill is H.R. 6168) in the last days of the current 109th Congress in order to be passed into law.

"I have a keen interest in S.3546 because I have been prescribing dietary supplements for over twenty years with great safety and success. However, in the past decade, a few unsavory manufacturers have tarnished the industry's reputation," noted Minsky, president and Wellness Director of Northbrook-based Nutritional Concepts and spokesperson for the American College of Nutrition. "This bill will help weed those manufacturers out, and in turn, help to assure the public that the industry is being regulated properly," she added.

S. 3546 passed by unanimous consent. Manufacturers, packers or distributors of OTC drugs or dietary supplements in the United States must notify the Food and Drug Administration (FDA) within 15 business days of any reports of any serious adverse events associated with their products. Serious events include death, a life-threatening experience, inpatient hospitalization, disability or incapacity, birth defect, or medical/surgical intervention to prevent one of these outcomes.

"This is a good bill that helps the Food and Drug Administration immediately respond to serious problems," said a spokesperson from Senator Durbin's office.

More than 150 million Americans use dietary supplement products, and critics of existing legislation believe that consumers deserve to know that if they report a serious adverse event they believe may be associated with a supplement product, that the regulatory body that oversees the supplement industry will be made aware of that report.

Many in the dietary supplement industry applaud the legislation. Steve Mister, president and chief executive officer of Council for Responsible Nutrition states, "We believe that, ultimately, such a system will highlight the strong safety record of dietary supplements. CRN strongly encourages the House of Representatives to consider the Senate-passed bill and quickly enact this legislation."