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. Quote Link to comment Share on other sites More sharing options...
Guest guest Posted December 13, 2006 Report Share Posted December 13, 2006 Pretty much all "bills" developed by these guys represent either overtly or covertly agendas that always direct themselves to increasing the wealth and power of the medical, pharmaceutical (chemical) industries, and eliminating competition for them. I don't have any idea why alternative/complementary health welcomes them at all. Just leave us the hell alone. - mirakulu2003 Wednesday, December 13, 2006 1:17 AM communicatio from Congressman Wu's Office OR Jeanne:This bill is in no way intended to curtail dietary supplements and itwill not restrict over the counter purchase. The bill as passedrequires a manufacturer, packer, or distributor of dietary supplementsto: (1) submit to the Secretary of HHS within 15 business days anyreport of a serious adverse event associated with use of such drug orsupplement in the United States; (2) submit within 15 business daysany related medical information that is received within one year ofthe initial report; (3) maintain records related to each report forsix years; and (4) permit inspection of such records. It also requiresthe Secretary to develop systems to ensure that duplicate reports of aserious adverse event are consolidated. It is just a way to keep trackof dangerous outcomes, which has definitely happened with certainsupplements, like ephedra.As to HR 2995/S517, the Congressman has not taken a formal position onthe bill yet, but I can tell you he has voiced concerns that thissubject area but not be entered into lightly.Hope this helps. Quote Link to comment Share on other sites More sharing options...
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