DSHEA Legislative Reform Effort Likely In 108th Congress Behind Sen. Durbin

Legislation to amend the Dietary Supplement Health & Education Act is a long-term goal of Sen. Richard Durbin (D-Ill.), according to his staff.

The senator expressed his desire to revise DSHEA during an Oct. 8 hearing of the Senate Governmental Affairs/ Oversight of Government Management Subcommittee on the safety and availability of ephedra. Addressing FDA Acting Commissioner Lester Crawford, PhD, the subcommittee chairman stated "it [is] clear to me that DSHEA is not protecting the American people."

"We have products being sold in this country today that people believe are safe, and they are not....Some people are dying as a result of these products. The fact that it takes so long for the federal government under [DSHEA] to even protect the American people, particularly our children, is proof positive this law needs to be changed."

The hearing dealt, in part, with the death of an Illinois teenager who was using an ephedra/caffeine combination supplement.

Durbin's staff said the hearing, along with one he convened in July on weight-loss supplements, is the first step in a deliberate approach to draft effective legislation. At the July hearing, Durbin mentioned the possibility of creating a regulatory category for herbal products separate from vitamins and minerals (¹ (Also see "Herbal Regulatory Category Creation At FDA Suggested By Sen. Durbin" - Pink Sheet, 5 Aug, 2002.), p. 4).

In the short term, Durbin's office said he is focusing on ensuring that FDA takes a more active role in enforcing current law by promulgating dietary supplement Good Manufacturing Practices and prohibiting firms from marketing supplements as street drug alternatives.

With the 107th Congress winding down, no bill will be introduced until after the Senate reconvenes in 2003. Although Durbin is up for reelection, polls indicate he should win his race fairly easily.

The National Nutritional Foods Association appears to be watching him closely, noting in an Oct. 10 release it will "monitor any progress on Durbin's agenda."

"Sen. Durbin's last hearing represented the first shot in what is likely to be an ongoing assault on DSHEA," Executive Director & CEO David Seckman said. "Although there is typically little activity during the upcoming congressional recess, I fully expect [him] to resume his offensive in January," he noted.

The Council for Responsible Nutrition sent Durbin a letter Oct. 11 asking to meet with him and his staff "to explore possibilities for cooperative action." In the letter, CRN advocated mandatory warning language and mandatory AE reporting for ephedra products.

In the House, Rep. Henry Waxman (D-Calif.) likely would support Durbin's call for legislative reform and could be a strong candidate to sponsor companion legislation. Waxman's staff on the House Government Reform Committee Minority Special Investigations Division worked with Durbin's subcommittee staff to compile an analysis of the adverse event reports recently released by Metabolife.

According to Durbin's staff, the Illinois Democrat has talked to Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa) for feedback regarding possible changes to the dietary supplement regulatory system.

While Hatch and Harkin could mount opposition to any changes proposed in the Senate, challenges are likely in the House as well. In an Oct. 8 release, House Government Reform Committee Chairman Dan Burton (R-Ind.) distanced himself from the AER analysis partly conducted by the committee's minority staff and noted he has asked the General Accounting Office to review Metabolife's AERs.

The report assembled by Waxman and Durbin's staffs concluded that 1,985 of the more than 13,000 AERs made public by Metabolife in August involved "significant" adverse reactions to the firm's products.

Distributed during the Oct. 8 Senate subcommittee hearing, the report found the adverse events reported to Metabolife included "three deaths, 20 heart attacks, 24 strokes, 40 seizures, 465 episodes of chest pains and 966 reports of heart rhythm disturbances."

Of the significant AEs, 1,667 involved cardiovascular problems such as heart attack, chest pain or high blood pressure, 64 involved neurological problems including stroke and seizure, and 321 involved psychiatric symptoms such as psychosis or anxiety.

Contrary to Metabolife's claims, healthy consumers and those who took the products according to label directions suffered from serious AEs, the report adds. For instance, in 27 of the 28 AERs involving heart attack, stroke, seizure or psychosis that included dosing information, consumers took the products "in the range recommended by the company."

Moreover, more than 50% of the AERs involved consumers under age 35, while 19% of those involving heart attack, stroke, seizure or psychosis "were filed by consumers who reported no prior medical problems," the analysis states.

To compile the report, congressional staffers looked at each Metabolife AER individually and placed it in a database if it fell into one of three categories of significant AEs: cardiac symptoms and conditions; neurological symptoms; or psychiatric symptoms.

Each record was examined for information on whether an emergency room visit or hospitalization had occurred, a doctor had indicated ephedra could be the responsible agent, the consumer was under 35 or overweight as measured by body mass index, there was any mention of prior medical history, and the dosage taken was listed.

Some of the strongest language in the report addresses the quality of Metabolife's AER data. The analysis notes basic information often was omitted, including the subject's age and gender, with "nearly one-third of the reports...handwritten, with notes that are sometimes illegible. In over 98% of the significant [AERs], there is no mention of Metabolife requesting the additional medical records needed for Metabolife to evaluate the role of its products in the adverse event."

Pointing to the report's findings, Durbin said "Metabolife's handling of [AERs] exhibits callous indifference to the health of [its] consumers."

Metabolife General Counsel Lanny Davis (Patton Boggs, Washington, D.C.) defended the company's AER collection system, noting that "unlike anyone else in the industry, we did this voluntarily, nobody required us to keep these records. The system evolved over the years - we're not proud of some of those early years where we were very haphazard about the records being kept, but we certainly did improve."

Durbin also referred to the ongoing Justice Department investigation into whether Metabolife improperly withheld its AERs from FDA. Noting the company had received calls from consumers prior to statements it made that it had never received an AER regarding any of its products, Durbin said "the record is damning for Metabolife."

"They can try to...disavow the common meaning of an adverse event in the English language, but I think it's clear...that suffering a heart problem or a stroke and reporting it to Metabolife is...the reporting of an event that adversely affected the customer," he said.