Guest guest Posted December 13, 2006 Report Share Posted December 13, 2006 Jeanne: This bill is in no way intended to curtail dietary supplements and it will not restrict over the counter purchase. The bill as passed requires a manufacturer, packer, or distributor of dietary supplements to: (1) submit to the Secretary of HHS within 15 business days any report of a serious adverse event associated with use of such drug or supplement in the United States; (2) submit within 15 business days any related medical information that is received within one year of the initial report; (3) maintain records related to each report for six years; and (4) permit inspection of such records. It also requires the Secretary to develop systems to ensure that duplicate reports of a serious adverse event are consolidated. It is just a way to keep track of dangerous outcomes, which has definitely happened with certain supplements, like ephedra. As to HR 2995/S517, the Congressman has not taken a formal position on the bill yet, but I can tell you he has voiced concerns that this subject area but not be entered into lightly. Hope this helps. Brian Brian Branton Legislative Director Office of the Honorable David Wu 1023 Longworth House Office Building Washington, DC 20515 phone: (202) 225-0855 fax: (202) 225-9497 http//www.house.gov/wu Quote Link to comment Share on other sites More sharing options...
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