The saving of DSHEA?
million in annual funding for national research under new
legislation to better implement DSHEA. The new bill, proposed by
Senators Harkin and Hatch last week, would also see FDA receive
$205 million over the next five years to enforce DSHEA.
The US dietary supplements industry could gain from an extra $10 million in annual funding for national research under new legislation to better implement DSHEA.
Senator Tom Harkin (D-Iowa) and Senator Orrin Hatch (R-Utah) introduced the legislation, called the DSHEA Full Implementation and Enforcement Act (S.1538), just before recess last week.
The Senators say the bill would help the US Food and Drug Administration (FDA) to fully implement the Dietary Supplement Health and Education Act (DSHEA), passed in 1994, but facing increasing questions about its ability to regulate supplements in the wake of ephedra lawsuits and the recent hearing.
The new legislation would also increase funding for the National Institutes of Health's Office of Dietary Supplements, created by DSHEA to expand research and provide consumer information on dietary supplements, from $20 to $30 million annually, according to trade association the National Nutritional Foods Association (NNFA).
"Passage of this legislation would once and for all end the debate over whether FDA has sufficient resources to implement DSHEA," said David Seckman, executive director and CEO of NNFA. "If this bill is passed, the FDA will have no more excuses for inaction. It will also put to rest the idea that Congress and the industry don't want to see DSHEA fully implemented," he added.
The DSHEA Full Implementation and Enforcement Act would see FDA receive a total of $205 million to deal with supplement regulation over the next five years, beginning with $20 million next year and increasing annually. The 2004 amount alone represents more than double the amount received by FDA this year, suggests NNFA, which says it is working on a strategy for members to respond to the new bill.
The bill also requires the FDA to submit a written report to Congress each year detailing how the agency is using its resources to regulate supplements.
Senators Harkin and Hatch also campaigned for proposed regulation for good manufacturing practices (GMPs) for dietary supplements, passed earlier this year. The comment period for GMPs closes next Monday, August 11.
