New Legislation Targets Full Implementation of DSHEA

May 27, 2010

By Ricardo Carvajal

Senators Harkin and Hatch have introduced the Dietary Supplement Full Implementation and Enforcement Act of 2010 (S. 3414).  The statement of findings notes that FDA has been slow to implement the Dietary Supplement Health and Education Act (“DSHEA”) of 1994, and proposes a substantial increase in funding for the agency’s implementation activities – $20 million in FY 2010, $30 million in FY 2011, “and such sums as may be necessary for each of fiscal years 2012 through 2014.”  In addition, NIH’s Office of Dietary Supplements would receive $40 million in FY 2011 “for expanded research and development of consumer information on dietary supplements” (with additional sums as needed in FY2012-2014).

The additional funding would come with some strings attached.  FDA would be directed to submit an annual report to Congress on its implementation and enforcement of DSHEA that includes information on (1) funding and personnel dedicated to dietary supplement regulatory matters (including compliance with good manufacturing practice requirements); (2) FDA’s reviews of new dietary ingredient notifications, as well as enforcement actions undertaken for failure to file a notification; and (3) FDA’s requests for substantiation of claims and any follow-up actions.  FDA would also be directed to issue guidance that addresses the applicability of the definition of “new dietary ingredient” (NDI) and of the NDI notification submission requirement, among other issues.  Finally, if FDA receives an NDI notification that raises safety concerns because the supplement might contain an anabolic steroid or analogue thereof, FDA would be directed to notify DEA.  

The bill received expressions of support during a recent hearing held by the Senate Special Committee on Aging that addressed concerns about the quality and marketing of certain dietary supplements.