The supplement industry's staunchest allies in the Senate, Tom Harkin and Orrin Hatch, introduce a bill aimed at fully funding dietary supplement regulation and timed to deflect criticism of the industry from a committee hearing.

The Dietary Supplement Full Implementation and Enforcement Act of 2010, ¹ S. 3414, was offered May 25 - the day before the Senate Special Committee on Aging held a hearing on the Government Accountability Office's investigation of herbal supplement marketing and claims (see ² Also see "Senate Supplement Hearing Spotlights Self-Regulation, FDA Enforcement" - Pink Sheet, 31 May, 2010. ).

The bill, reconstituted from legislation Harkin and Hatch offered in 2003, "authorizes additional resources to ensure the FDA has what it needs to fully implement and enforce our dietary supplement laws, and also holds the FDA accountable for what it does with those resources," said Harkin, D-Iowa, in a release.

The current legislation would allocate at least $20 million from FDA appropriations in fiscal 2010 for activities related to enforcing the Dietary Supplement Health and Education Act. For fiscal 2011, S. 3414 would authorize the appropriation of $30 million, followed by "such sums as may be necessary" each year through 2014.

The bill also would authorize $40 million in 2010 appropriations for consumer information research in the National Institutes of Health's Office of Dietary Supplements, as well as necessary annual amounts through 2014.

Harkin and Hatch's ³ bill that stalled in the 108 Congress would have authorized $20 million to FDA in 2004 for DSHEA enforcement. The authorization was to increase annually through 2008, when the amount was slated to be $65 million - the high end of FDA's estimated funding need to implement DSHEA's good manufacturing practice inspections, adverse event report analysis and other measures (⁴ Also see "Dietary Supplement Safety Issues Maintain Momentum On Capitol Hill" - Pink Sheet, 29 March, 2004.).

Rep. Dan Burton, R-Ind., offered a DSHEA full implementation bill in July 2009, H.R. 3263, which has not moved in the House and has no co-sponsors (⁵ Also see "Legislation Seeks Space For Supplements On Health Care Reform Slate" - Pink Sheet, 27 July, 2009.). Staffers would not say whether Burton continues to push the bill and whether it is a companion to S. 3414.

Like its earlier iteration, S. 3414 calls for the Department of Health and Human Services to submit an annual accountability report to Congress on the progress of DSHEA enforcement.

S. 3414 features further provisions developed in the wake of Sens. John McCain and Byron Dorgan agreeing to withdraw support for their Dietary Supplement Safety Act, S. 3002, which would have overhauled DSHEA and which industry strongly opposed (⁶ Also see "Hatch Flips Focus To NDI Guidance In McCain Steroid Bill Negotiations" - Pink Sheet, 15 March, 2010.).

Harkin and Hatch's bill would require FDA to publish the long-awaited new dietary ingredient notification guidance within 180 days of enactment. It also would have FDA notify the Drug Enforcement Administration of any NDI submissions containing an anabolic steroid.

During the May 26 Senate hearing on GAO's herbal product investigation, FDA Principal Deputy Commissioner Josh Sharfstein acknowledged the NDI guidance is needed (see story p. 13).

"Everybody wants this guidance out," Sharfstein said, adding that FDA plans to publish the document by the end of 2010.

Industry Knows Its Champions

As expected, dietary supplement stakeholders have rallied around S. 3414. The Council for Responsible Nutrition calls it "a step in the right direction" toward more comprehensive enforcement of regulations, and the American Herbal Products Association notes it would protect consumer access to supplements.

The odds seem long for S. 3414 gaining legislative momentum in the 111 Congress. CRN is "hopeful" the bill will pass, but acknowledges the obstacles it faces.

"It does have some things working against it because we're in an election year, and Congress is going to spend a lot of time over the next six months going home to campaign, which cuts into their ability to get work done," said CRN President and CEO Steve Mister.

He added, at the very least, the bill can be used to highlight FDA's lack of resources, and Harkin and Hatch have laid groundwork for moving similar legislation in the future.

- Dan Schiff ( ⁷ d.schiff@elsevier.com )

Harkin, Hatch Reload In Hunt For Full DSHEA Funding, Implementation

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