McCain Bill Would Affect DSHEA
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Copyright 2009 by Virgo Publishing.
http://www.naturalproductsinsider.com/
By:
Posted on: 02/03/2010
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WASHINGTON—Sen. John McCain (R-Ariz.) has introduced the Dietary Supplement Safety Act of 2010, which would amend Federal Food, Drug and Cosmetic Act (FFDCA) and threaten parts of the Dietary Supplement Health and Education Act of 1994 (DSHEA), such as new dietary Ingredients (NDIs). Co-sponsored by Sen. Byron Dorgan (D-N.D.) and backed by the U.S. Anti-Doping Agency (USADA) and several pro and amateur sports bodies, the bill aims “to more effectively regulate dietary supplements that may pose safety risks unknown to consumers.”
Specifically, the bill calls for dietary supplement facilities to not only register its name and address, but also all trade names and a list of all dietary supplements “manufactured, packaged, held, distributed, labeled, or licensed by the facility.” Further, all ingredients contained in each supplement must also be disclosed in this registration, which is to be updated annually—any reformulations or new ingredients would be noted in such an update.
On new dietary ingredients, the 75-notificaiton would say the same under the McCain bill, but ingredients marketed in the United States prior to Oct. 15, 1994 would no longer be automatically excluded from NDI requirements, but the Secretary would maintain a list of Accepted Dietary Ingredients. The bill also contains substantiation filing and evidence of compliance requirements, as well as monetary penalties for non-compliance.
In addition to these changes, the McCain bill would change existing mandatory serious adverse event reporting (SAER) regulations to require minor averse events also be mandatorily reported.
full article;
http://www.naturalproductsinsider.com/news/2010/02/mccain-bill-would-affect-dshea.aspx#
--------------------------------------------------------------------------------
Copyright 2009 by Virgo Publishing.
http://www.naturalproductsinsider.com/
By:
Posted on: 02/03/2010
--------------------------------------------------------------------------------
WASHINGTON—Sen. John McCain (R-Ariz.) has introduced the Dietary Supplement Safety Act of 2010, which would amend Federal Food, Drug and Cosmetic Act (FFDCA) and threaten parts of the Dietary Supplement Health and Education Act of 1994 (DSHEA), such as new dietary Ingredients (NDIs). Co-sponsored by Sen. Byron Dorgan (D-N.D.) and backed by the U.S. Anti-Doping Agency (USADA) and several pro and amateur sports bodies, the bill aims “to more effectively regulate dietary supplements that may pose safety risks unknown to consumers.”
Specifically, the bill calls for dietary supplement facilities to not only register its name and address, but also all trade names and a list of all dietary supplements “manufactured, packaged, held, distributed, labeled, or licensed by the facility.” Further, all ingredients contained in each supplement must also be disclosed in this registration, which is to be updated annually—any reformulations or new ingredients would be noted in such an update.
On new dietary ingredients, the 75-notificaiton would say the same under the McCain bill, but ingredients marketed in the United States prior to Oct. 15, 1994 would no longer be automatically excluded from NDI requirements, but the Secretary would maintain a list of Accepted Dietary Ingredients. The bill also contains substantiation filing and evidence of compliance requirements, as well as monetary penalties for non-compliance.
In addition to these changes, the McCain bill would change existing mandatory serious adverse event reporting (SAER) regulations to require minor averse events also be mandatorily reported.
full article;
http://www.naturalproductsinsider.com/news/2010/02/mccain-bill-would-affect-dshea.aspx#