Sen. Tom Harkin asserts he will stand in the way of any attempted legislative changes to the Dietary Supplement Health and Education Act, as criticism of the 1994 law persists.

Speaking at the Natural MarketPlace conference and trade show July 11 in Las Vegas, the Iowa Democrat and long-time industry ally also said he expects a significant role for wellness and prevention in health care reform.

On the issue of supplement regulation, DSHEA "is not going anywhere," the five-term senator said.

"I've got good staff on top of this. We have our friends in the House who have staff on this," he said. "We're going to be keeping our eyes open for anything that might come through that would in any way undo or restrict DSHEA."

Harkin expressed concern, however, that Rep. Henry Waxman, D-Calif., might take a back-door approach to weakening DSHEA via a "simple little amendment on some bill that has to go through."

In a book published July 2, "The Waxman Report: How Congress Really Works," the House Energy and Commerce Committee chairman has harsh words for DSHEA.

The frequent supplement industry antagonist recounts the legislative battle leading up to DSHEA's passage, during which he found himself "cast in the unaccustomed role of villain" by supplement stakeholders.

Waxman says the lack of support for his FDA reform bill at the time -- which was not aimed specifically at supplements -- as well as his opposition to unproven health claims, led him to relent and agree to DSHEA's FDA supplement disclaimer provision.

The law, he writes, has proven "every bit as harmful as we feared, demonstrating anew that any market lacking regulation or the need to ensure safety quickly sinks to the lowest common denominator."

Waxman adds that while the Bush administration did not fulfill congressional attempts to impose tighter regulations on supplements, Congress could have success under the more aggressive regulatory approach of the Obama administration.

"One enduring truth about Washington is that no issue is ever settled for good," Waxman says.

A Government Accountability Office ¹ report released in March recommends more stringent adverse event reporting requirements for supplements, enhanced FDA recordkeeping of product labels and registration of manufacturing facilities (² Also see "Congress Says GAO Report Supports Increasing Supplement Oversight" - Pink Sheet, 9 March, 2009.).

Industry critics including Rep. John Dingell, D-Mich., and Sen. Dick Durbin, D-Ill., as well as Waxman seized on the report as another indication of the need for additional regulation and FDA authority over supplements.

While Harkin assured supplement stakeholders that he and another staunch supplement supporter, Sen. Orrin Hatch, R-Utah, would stand in the way of any legislative efforts to undo DSHEA, he asked the industry to be vigilant and identify regulatory guidances and rulemakings that could effectively alter the way supplements are sold.

He said regulators involved in such activity will be called to testify before a congressional panel. Harkin chairs the Agriculture, Nutrition and Forestry Committee, and sits on the Appropriations; Health, Education, Labor and Pensions; and Small Business and Entrepreneurship committees.

FDA Commissioner Margaret Hamburg has left the question open as to whether she believes DSHEA gives the agency sufficient regulatory authority over supplements (³ Also see "Hamburg Leaves Open Question On Supplement Regulation Adequacy" - Pink Sheet, 11 May, 2009.).

HELP For Health Reform

Harkin said he pushed for the wellness and prevention provisions included in the Affordable Health Choices Act the HELP Committee approved July 15. The panel voted 13-10, along party lines, to send the bill to the full Senate.

While the Senate waits for the Finance Committee's health reform bill, which media suggest is delayed by a ballooning price tag, Harkin said the Senate's eventual bill will include a dedicated $10 billion annual authorization for prevention and wellness purposes (⁴ Also see "Health Care Reform Percolates, With OTC Benefit Cuts On Congress’ Table" - Pink Sheet, 22 June, 2009.).

The emphasis on wellness and prevention in health reform presents business opportunities to OTC drug and supplement firms.

Johnson & Johnson, for example, expects that offering wellness and prevention services and products will help the firm compete for more of the approximately $4.1 trillion in annual global health care spending, company executives said in March (⁵ Also see "J&J Sees Opportunities In Wellness Under Health Care Reform" - Pink Sheet, 23 March, 2009.).

J&J said its acquisitions in the wellness and prevention arena contributed to overall sales growth in its latest quarter (see story p. 4).

The HELP bill also establishes community-based demonstration projects to measure the health benefits and cost savings associated with calcium plus vitamin D, folic acid and fish oil supplementation -- part of an amendment Harkin said he introduced with Hatch.

Remaking the U.S. "as a genuine wellness society" involves encouraging vitamin and mineral supplementation, smoking cessation and other methods of self-care in clinics and community health centers, he added.

Natural Products Association VP of Scientific and Regulatory Affairs Daniel Fabricant said the community demonstration projects will ideally yield "good metrics on cost savings" associated with nutrient supplementation.

The House committees on Education and Labor and Ways and Means completed consideration July 17 of H.R. 3200, the America's Affordable Health Choices Act of 2009 (see ⁶ Also see "OTC Coverage Loses Out In House Ways And Means Health Care Reform Bill" - Pink Sheet, 20 July, 2009. ). Energy and Commerce is slated to mark up the bill through July 22.

The legislation, introduced by Dingell July 14, establishes a prevention and wellness trust with funding through 2019, starting at $2.4 billion in fiscal 2010. Funds also are authorized for prevention and wellness research, delivery of community services and core public health infrastructure and activities.

H.R. 3200 additionally sets up task forces on clinical and community preventive services and requires the secretary of Health and Human Services to lay out a national prevention and wellness strategy.

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

Sen. Harkin Defends DSHEA, Promotes Supplements In Health Legislation

More from Archive

More from Pink Sheet