FDA NDI Draft Is A Push For Tighter Supplement Regulation

FDA NDI Draft Is A Push For Tighter Supplement Regulation – Stakeholders

FDA proposed “a pretty crazy” NDI notification draft guidance, says attorney Wes Siegner, because “they think everything is an NDI.” Other stakeholders acknowledge FDA wants tighter regulation of the industry, but say writing and imposing rules for supplement manufacturing is a two-way street.

FDA’s most striking attempt to exceed the regulatory limits Congress established in the Dietary Supplement Health and Education Act is the July 2011 draft guidance on new dietary ingredient notifications, according to some industry stakeholders.

While acknowledging that the NDI notification requirement is needed to help keep unsafe products off the market, the stakeholders say...