09.01.06
AER Bill Introduced
New legislation pertaining to the reporting of serious adverse events was proposed on June 21st. The legislation, Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was introduced by Senators Orrin Hatch (R-UT), Richard Durbin (D-IL), Tom Harkin (D-IA), Mike Enzi (R-WY) and Edward Kennedy (D-MA). According to the United Natural Products Alliance (UNPA), Salt Lake City, UT, this bill would provide better early warning signals in the rare event a serious adverse event occurs. It will also be able to identify a batch of products that have been adulterated or tampered with. Organizations like UNPA hope this will increase consumer confidence in the safety of their supplements and help companies more rapidly identify and correct a problem, should one occur. The American Herbal Products Association (AHPA), Silver Spring, MD, says companies will be required to include on product labels an address or phone number through which consumers can report adverse events that they associate with their use of a supplement or over-the-counter (OTC) drug. Companies will be obligated to inform FDA of any serious adverse event reports they receive within 15 business days. Other organizations supporting the bill include the Council for Responsible Nutrition (CRN), Washington, D.C., and the Natural Products Association (NPA), formerly the NNFA, Washington, D.C. (More details on this issue can be found on page 66.)
New legislation pertaining to the reporting of serious adverse events was proposed on June 21st. The legislation, Dietary Supplement and Non-Prescription Drug Consumer Protection Act, was introduced by Senators Orrin Hatch (R-UT), Richard Durbin (D-IL), Tom Harkin (D-IA), Mike Enzi (R-WY) and Edward Kennedy (D-MA). According to the United Natural Products Alliance (UNPA), Salt Lake City, UT, this bill would provide better early warning signals in the rare event a serious adverse event occurs. It will also be able to identify a batch of products that have been adulterated or tampered with. Organizations like UNPA hope this will increase consumer confidence in the safety of their supplements and help companies more rapidly identify and correct a problem, should one occur. The American Herbal Products Association (AHPA), Silver Spring, MD, says companies will be required to include on product labels an address or phone number through which consumers can report adverse events that they associate with their use of a supplement or over-the-counter (OTC) drug. Companies will be obligated to inform FDA of any serious adverse event reports they receive within 15 business days. Other organizations supporting the bill include the Council for Responsible Nutrition (CRN), Washington, D.C., and the Natural Products Association (NPA), formerly the NNFA, Washington, D.C. (More details on this issue can be found on page 66.)