Dietary data legislation opposed

Should the dietary supplement industry be required to notify the government when its products cause adverse side effects?

Bruce Hough, president of Park City-based Nutraceutical Corp., says no.

However, legislation before Congress might force companies like Nutraceutical — which manufactures 3,000 nutritional and herbal products — to do exactly that.

Hough says Utah's nutritional and dietary supplement industry, with annual revenues estimated between $3 billion and $4 billion, is under attack.

At the center of the debate is the Dietary Supplement and Nonprescription Drug Consumer Protection Act, a bill that would require nutritional supplement manufacturers to report to the Food and Drug Administration any serious adverse health events arising from their products.

On Monday, the issue was debated in downtown Salt Lake City.

"It doesn't really do anything other than create an overlay of bureaucracy on an industry that doesn't really have issues now," Hough said. "This is a solution looking for a problem, and there really isn't a problem."

Drug manufacturers are required to notify the government of all known adverse health events involving their products.

And Steven Mister, president of the Council for Responsible Nutrition, a trade organization based in Washington, D.C., that represents about 70 manufacturers of dietary supplements, said its members overwhelmingly support the legislation.

"If a consumer calls a company and tells the company that they had a serious adverse event, they ought to have a right to expect that the company is going to tell the FDA about it," Mister said. "This industry has a credibility problem with Congress and FDA because there's a perception that there is a serious problem."

Jonathan Emord, a legal expert in food and drug law, said under the new legislation anyone could file a complaint and not provide any proof of injury.

"The complaints are posted on the Web, so the information becomes, to the extent it is not true, defamatory," Emord said. "This is an open-ended invitation to expand the scope of inspections and inquiry into the operations of a dietary supplement company through the window of a complaint that may not even be legitimate."

Emord said the bill imposes a burden of proof on every accused company to establish that its product is safe by rebutting every adverse event report that is filed.