Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: THURSDAY, May 12, 1994 TAG: 9405120175
SECTION: BUSINESS PAGE: B-8 EDITION: METRO
SOURCE: Associated Press
DATELINE: WASHINGTON LENGTH: Medium
A Senate committee agreed that makers of vitamins and other dietary supplements must, for two years, abide by new rules about what they can claim to do for health.
In return, a congressionally appointed committee will study ways to avoid what senators called the Food and Drug Administration's history of bias against the $4 billion supplements industry.
``This is a great thing we're doing,'' said the bill's author Sen. Orrin Hatch, R-Utah. ``We're saying we want the American people to be as healthy as they can.''
The Senate Labor and Human Resources Committee spent almost two hours Wednesday debating Hatch's legislation, as senators argued whether they were stripping the FDA of its ability to safeguard consumers. Hatch pledged to rewrite the bill to reflect some concerns before the legislation reaches the Senate floor, possibly next week.
Beginning July 15, new FDA regulations will require dietary supplement makers to prove there is ``significant scientific agreement'' before ever claiming, for example, that a vitamin prevents a certain disease.
That's the standard Congress set for foods that make health claims, and the FDA says dietary supplements shouldn't get off any easier.
``I urge you to not water down the scientific standards,'' FDA Commissioner David Kessler told a Senate Appropriations subcommittee Tuesday. ``Otherwise, nobody will know what to believe.''
But the supplements industry feared the regulations would serve as an excuse for FDA to take supplements off the market and said the scientific proof standard was too high.
Hatch agreed. His bill would force FDA to show that a supplement was ``ordinarily'' dangerous, not just occasionally dangerous, before ever banning one.
But he changed his mind about the health claims. First, Hatch's bill said such claims should reflect the totality of scientific evidence. Now he has agreed to let supplement claims fall under the new FDA rules for two years, while a congressionally appointed panel studies what to do.
``We were willing, as a compromise, to wait two years ... while we look for a process that will take the final decision out of the FDA,'' said Gerald Kessler, head of the Nutritional Health Alliance that opposes the FDA rules.
Sen. Edward Kennedy, D-Mass., argued Wednesday that ever easing FDA's standard of scientific proof could put the public at risk of consuming pills that claim to cure cancer or AIDS, unproven claims that are now on the market.
FDA says it hasn't gone after those supplements vigorously because it lacks the money and personnel to do so - one reason the agency is requiring prior approval of health claims.
by CNB