The Senate passed a compromise bill Saturday that would prevent the Food and Drug Administration from regulating dietary supplements as strictly as it does prescription drugs.
But the measure would make manufacturers of vitamins, minerals, herbal products and amino acids comply with a nutrition labeling law for two years until a new commission decides the most appropriate way to deal with dietary supplements.For example, the Nutrition Labeling and Education Act says there must be "significant scientific agreement" before a manufacturer could claim a vitamin prevents a certain disease.
The Senate-passed bill would put health claims for foods and dietary supplements on the same basis for now.
Sen. Orrin Hatch, R-Utah, who has led the fight against stricter FDA regulation of the $4 billion-a-year dietary supplements industry, called it a major breakthrough.
"It keeps the FDA from being able to come in and put these products, which have been around for 4,000 years . . . through a pre-clearance process similar to the drug clearance process," he said.
"The battle now is in the House. A lot of people didn't think we could get it done this year," said Hatch. "There's going to be an absolute war over there if they don't (pass) it."
The measure was approved by voice with only Hatch and a couple of other senators on the floor at the end of a day of speeches about health reform.
Hatch said other senators had signaled their support in advance. The measure had 66 co-sponsors in the Senate and has 250 in the House, Hatch said.
Hatch said the bill makes clear that dietary supplements are not food additives or drugs and puts the burden of proof on the FDA to prove that a product is unsafe.
Hatch said the FDA has been trying since 1962 to "over-regulate" the diet supplement industry but has been repeatedly blocked by Congress or the courts.