Bill would crack down on dietary aids

The dietary supplement industry is backing federal legislation that for the first time would require supplement manufacturers to report serious adverse events linked to their products to the Food and Drug Administration.

The American Medical Association welcomed the measure, said President-elect Ron Davis, MD. "We think it's a small step in the right direction, and we hope the legislation passes."

The Dietary Supplement and Nonprescription Drug Consumer Protection Act would require manufacturers, packers and distributors of these products to inform the FDA within 15 business days of any "serious adverse events" reported to them by consumers or health care professionals.

The bill defines serious adverse events as incidents that result in death, a life-threatening experience, hospitalization, a persistent or significant disability or incapacity, or a congenital anomaly. The new requirement also would apply to some over-the-counter medications, such as aspirin, that are not subject to mandatory adverse event reporting.

The bill's lead sponsors are Sen. Orrin Hatch (R, Utah), a longtime champion of the dietary supplement industry, and Sen. Dick Durbin (D, Ill.), an outspoken critic of the way supplements have been regulated. The legislation "strikes the right balance between necessary regulation and over-regulation," Hatch said when he introduced the bill June 21.

The measure could be on a fast track for congressional approval this year. A companion bill has not yet been introduced in the House, but the legislation sailed through the Senate Health, Education, Labor and Pensions Committee June 28 on a unanimous voice vote.

Making a perception reality

Manufacturers of dietary supplements and some OTC drugs now report adverse events to the FDA on a voluntary basis. Consumers and health care professionals also can report adverse events directly to the agency through the MedWatch program.

But many don't realize that if they report problems with dietary supplements to the manufacturer, the information doesn't need to be passed on to the FDA, said Adriane Fugh-Berman, MD, associate professor of physiology and biophysics at Georgetown University School of Medicine in Washington, D.C. "They assume action will be taken, but it's entirely up to the manufacturer," she said.

In the case of ephedra, it eventually came to light that manufacturers had been sitting on a lot of adverse event reports that they had failed to pass on to the FDA, Dr. Fugh-Berman said.

The agency banned sales of ephedra products in 2004, after more than 18,000 adverse events and an estimated 100 deaths were tied to weight-loss products containing the amphetamine-like herb. A federal judge in Utah struck down the ban in 2005 in response to a lawsuit brought by Nutraceutical International Corp., which had marketed ephedra as a dietary supplement. The FDA has appealed the ruling.

Critics of the way dietary supplements are regulated, including the AMA, for several years have urged Congress to require that supplement manufacturers report adverse events to the FDA, as manufacturers of prescription drugs and many OTC medications are required to do.

Although the AMA applauded the new bill, it has advocated more sweeping changes to address dietary supplement concerns, "including requiring manufacturers to provide evidence their products are safe and effective before being allowed to introduce them to the market," Dr. Davis said.

Winning back consumers

For their part, supplement makers and retailers hope the bill will boost consumers' trust in their products, which has wavered in recent years due to negative reports about the safety and efficacy of some products.

Mandatory reporting should help assure consumers and doctors that supplements are safe, said Steve Mister, president and CEO of the Council for Responsible Nutrition, a Washington, D.C.-based trade association that represents dietary supplement manufacturers and ingredient suppliers.

"Consumers will have more confidence because they will know that if they tell a manufacturer about a serious event related to a dietary supplement, the FDA will know about it," Mister said.

He also acknowledged that the industry is concerned about public perception of its products. "Consumer confidence has taken a hit in the past few years as a result of media reports and misreporting of some study results," he said.

Dietary supplements are a booming business. Sales in the United States topped $21.3 billion in 2005 -- up 4.5% from $20.4 billion in 2004, according to the Nutrition Business Journal, a San Diego-based research and publishing company.

But sales of some supplements recently have seen a sharp decline in the wake of heightened public concern about their safety and efficacy.

For example, U.S. sales of vitamin E supplements were down 25% in 2005, according to Nutrition Business Journal. The drop followed widespread media coverage of published studies that found daily vitamin E doses of 400 international units (IU) or more can boost the risk of heart failure.

Nutraceutical, based in Park City, Utah, did not return calls for comment on the legislation. But the company's chief operating officer, Jeffrey Hinrichs, sits on the board of the Council for Responsible Nutrition, one of several industry trade associations that endorsed the bill the day it was introduced in the Senate. Others include the Consumer Healthcare Products Assn., the American Herbal Products Assn., the National Nutritional Foods Assn., and the Utah Natural Products Assn.

Two Washington, D.C.-based public advocacy groups, Consumers Union and the Center for Science in the Public Interest, also have endorsed the bill. "It's a major step forward," said Bill Vaughan, a senior policy analyst at Consumers Union.