Rep. Henry Waxman has planned a hearing in November on dietary supplements that will give him a platform to make a case for amending the law that regulates the industry.

An effort to reform the Dietary Supplement Health and Education Act - an attack on the bill, as some see it - appears inevitable in this Congress, experts agree. However, they contend a legislative push likely will be delayed until 2010.

Waxman's committee, Energy and Commerce, will hold a hearing in November to discuss National Football League players' drug-test violations, according to an Oct. 8 Associated Press report.

The hearing, at a date to be set, will address athletes' violations after using the weight-loss supplement StarCaps . NFL players alleged the supplement label did not state that it contains bumetanide, a diuretic banned by the league as a performance-enhancing substance because it disguises steroid use (¹ 'The Tan Sheet' Dec. 1, 2009).

John Manthei, an attorney with Washington-based Latham & Watkins, notes, "There has been a major push the last few years to take a hard look at the adequacy of FDA's regulatory scheme across all product categories."

Lawmakers have taken a hard look at the pharmaceutical industry over the years, closely scrutinized food and food safety over the past year and, more recently, looked into medical devices. Manthei, a former Energy and Commerce Committee counsel, would not be surprised to see reforms to DSHEA considered next year.

"I think it would be natural, certainly, for dietary supplements to be on that list," he said.

DSHEA "may come up for consideration in terms of whether it is adequately enforced by the agency, or whether amendments to the current statute are needed," such as tacking on pre-market requirements, Manthei added.

But that's unlikely in 2009, he said. Energy and Commerce and the Senate committee with jurisdiction over those issues - Health, Education, Labor and Pensions Committee - will be tied up with health care reform legislation at least until 2010.

Natural Products Association President Pat Sardell agrees lawmakers will focus on health care reform the rest of this year. But at the Expo East trade show recently in Boston, Sardell said she expected Waxman, D-Calif., would conduct hearings on supplements.

Waxman requested the Government Accountability Office's March 2009 report on supplements that recommended increased oversight of the industry (² Also see "Congress Says GAO Report Supports Increasing Supplement Oversight" - Pink Sheet, 9 March, 2009.).

"While the report was better than industry expected - and probably not as bad as Rep. Waxman would have liked - it will likely be used as the basis for a hearing in the future," Sardell said.

The Senate assistant majority leader, Dick Durbin, D-Ill., has "also been a long-time critic of our industry and most likely will join the assault of misinformation and calls to dismantle DSHEA," Sardell said.

"In key leadership roles in their respective chambers, coupled with a widened majority of partisan Democrats behind them, Waxman and Durbin are determined to launch attacks and changes that they haven't been able to do in the past," she said.

While Waxman heads Energy and Commerce, a DSHEA proponent - Iowa Democrat Tom Harkin - is Senate HELP chairman.

The net impact on the supplement industry from this leadership is hard to predict, Manthei said. Based on his experience in Congress and from his work with the two lawmakers, he said he expects Harkin and Waxman will work well together.

Democrats' majority in both chambers should continue to be evident in oversight of FDA.

"Given the margins in the House and the Senate, reforms to FDA's regulatory process are no longer limited to the once-every-five-year cycle of the reauthorization of the major user fee programs as it has been in the last 15 years. It can potentially happen every year, and we should expect food and supplements to be discussed in 2010," Manthei said.

He said a Senate food safety bill might be delayed until 2010. The House passed the Food Safety Enhancement Act, H.R. 2749, July 30 (³ Also see "House Passes Food Safety Bill That May Not Be Appetizing To Senate" - Pink Sheet, 3 August, 2009.).

- Katie Stevenson ( ⁴ k.stevenson@elsevier.com )

DSHEA Reform Amendment Efforts Likely, Supplement Hearing Slated

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