On Monday, a lawyer for the industry and one for a consumer group offered those outcomes and debated whether companies should be required to inform the Food and Drug Administration of adverse reactions to nutritional products. They waged their verbal battle during a meeting of the Association of Corporate Counsel at the Marriott Hotel in Salt Lake City.
Policy now allows companies and consumers to voluntarily report adverse events for both supplements and over-the-counter drugs. But Sen. Orrin Hatch, R-Utah, and Sen. Richard Durbin, D-Ill., are crafting a bill requiring dietary manufacturing firms to report serious reactions in the hopes of getting more information to detect potential problems.
Today, most of the information is provided to the FDA by manufacturers, according to the agency, which is charged with ensuring the safety of all marketed medical products.
Information from the FDA's reporting system, called MedWatch, is not public, but attorney Jonathan Emord, who practices food and drug law and is challenging the FDA ban of the stimulant ephedra, worries it might be.
"It will be Christmas all over again for product liability and personal injury lawyers," said Emord. "[It] will be a breeding ground for disgruntled employees and unscrupulous competitors."
Emord said the current voluntary reporting system and the proposed mandatory one have no penalties for providing false information and no backup or screening to ensure reports are accurate. He labeled both as un-American and as dangerous as the 1690s witch trials in his home state of Massachusetts.
But Bruce Silverglade, legal director of the Center for Science in the Public Interest, based in Washington, D.C., said consumers and physicians are providing valuable information to the FDA. The data can be used to reveal patterns requiring further research that could lead to recalls of unsafe products.
The FDA's tracking system was put in place in four years ago to replace a patchwork of existing systems maintained by a variety of government agencies.
Loren Israelsen, executive director of the Utah Natural Products Alliance, based in Salt Lake City, said mandatory reporting is in the best interest of the public and of companies.
"Good companies already have investigative procedures in place," he said. "If something unexpected happens, we in the industry would like to be the first to know about it, to promptly investigate and to understand that it could be a single quality defect by a lone manufacturer, a false report or bioterrorism."
Dietary supplements are a $2.5 billion business in Utah, with 80 to 100 companies manufacturing and marketing the products.
About 60 percent of Americans take some form of dietary supplement daily, according to the FDA. Although supplements may include beneficial vitamins and minerals, some have risks. For instance, ginkgo biloba may cause excessive bleeding, Vitamin A in high doses may lead to birth defects, and the government banned ephedra in 2004 after the stimulant was linked to dozens of cases of heart problems, strokes and deaths.
Unlike prescription and over-the-counter drugs, the FDA does not have the authority to require supplements to undergo pre-market approval for safety. Instead, the agency relies on its adverse event reporting system to identify problems.
Hatch had championed the Dietary Supplement Health and Education Act in 1994, which allows the FDA to pull supplements only if the agency can prove they pose "significant or unreasonable risks."
dawn@sltrib.com
