DSHEA Implementation Action Expected In Second Session Of 108th Congress
This article was originally published in The Tan Sheet
Executive Summary
A House version of the Dietary Supplement Health & Education Act "Full Implementation" Senate bill is expected early this year, marking the impact of industry efforts to respond to a challenging year in Washington
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A House version of the Dietary Supplement Health & Education Act "Full Implementation" Senate bill is expected early this year, marking the impact of industry efforts to respond to a challenging year in Washington. Rep. Frank Pallone (D-N.J.) intends to introduce a companion to S 1538, the "DSHEA Full Implementation and Enforcement Act of 2003" before the Presidents' Day recess. The Senate bill, introduced by supplement champions Tom Harkin (D-Iowa) and Orrin Hatch (R-Utah) would authorize $20 mil. in funding for FDA dedicated to DSHEA implementation, growing incrementally to $65 mil. in FY 2008 (1 (Also see "DSHEA Implementation Would Get Funding Push Under Harkin/Hatch Bill" - Pink Sheet, 4 Aug, 2003.), p. 13). While Pallone's bill is still being hammered out with input from constituents and stakeholders, it will be based on the Hatch/Harkin bill. An important feature of the Senate bill calls for increased accountability to Congress from the FDA regarding its progress in implementing the legislation. Annual reports would be required, detailing enforcement actions, inspections and other activities. The bill also would provide funding increases for the NIH's Office of Dietary Supplements. Pallone's bill may add educational initiatives and address adverse event reporting as well. Momentum in support of DSHEA implementation appears to be growing in the wake of the ephedra controversy. Congressional activity and media attention on the industry in 2003 were largely driven by the debate on ephedra. While FDA's decision to ban ephedra, announced at the end of December, is being pitched by many as a sign that DSHEA works, others say the slow process leading to the ban indicates the need for reform (2 (Also see "Ephedra Ban Court Challenge Could Be Good News For FDA, Win Or Lose" - Pink Sheet, 12 Jan, 2004.), p. 14). Talk among lawmakers about DSHEA reform has pushed industry to refocus lobbying efforts in Washington. The Council for Responsible Nutrition announced it has hired the lobbying firm of Bergner, Bockorny, Castagnetti & Hawkins "to assist in its ongoing legislative efforts," the group announced Jan. 15. The decision reflects concerns raised by the legislative environment in 2003: the group previously had worked with lobbying firms but brought those activities in-house last January. As events unfolded on the Hill in 2003, the trade group decided it was important to bring in outside help. Ephedra foe Sen. Richard Durbin introduced S 722 last March, which would require pre-approval for supplements containing stimulants (3 (Also see "Supplements Containing Stimulants Would Need Preapproval Under Durbin Bill" - Pink Sheet, 31 Mar, 2003.), p. 3). A bill from Reps. Susan Davis (D-Calif.), Henry Waxman (D-Calif.) and John Dingell (D-Mich.) called for mandatory adverse event reporting for supplements containing herbs, amino acids and other botanicals (4 (Also see "House Bill Prohibits Sale Of High-Risk Supplements To Minors" - Pink Sheet, 3 Nov, 2003.), p. 13). House Energy & Commerce Committee hearings on ephedra in July provoked a number of Reps to call for DSHEA reform. "One thing we've learned from all the legislative activity that took place in the first half of the 108th Congress is that we need to educate Congressional offices about our industry, our consumers, our science-based products, and the appropriate regulatory framework DSHEA provides for dietary supplements," said CRN president Annette Dickinson, PhD. Bergner, Bockorny's assignment is to "strengthen CRN's Congressional outreach and education efforts, which focus on the positive health benefits of supplements and the need for fuller implementation" of DSHEA. According to CRN, it selected a firm that did not have experience in the supplement field in order to get an outside perspective. The firm's "bi-partisan connections that reach across both houses of Congress" were a draw as well. In addition to DSHEA-related action, the second session is likely to see legislation aimed at taking androstenedione and other steroid precursors off the market. |