A Senate committee approved legislation Wednesday that would delay the imposition of new Food and Drug Administration restrictions on the nutritional claims made by vitamin manufacturers.
Rejecting a more restrictive proposal by its chairman, Sen. Edward M. Kennedy (D-Mass.), the Senate Labor and Human Resources Committee instead approved legislation sponsored by Sen. Orrin G. Hatch (R-Utah) on a 12-5 vote.
Hatch’s bill, which could go to the full Senate as early as next week, would delay for three years labeling regulations for dietary supplements, which are scheduled to go into effect on July 15.
Left unchallenged, those regulations would require manufacturers to show that “significant” scientific agreement exists before claiming that a particular vitamin or nutritional supplement can help prevent or cure any disease.
Kennedy’s bill would have modified but essentially retained the standards proposed by the FDA to regulate the $4-billion-a-year nutritional supplement industry, which critics claim often makes misleading and unsubstantiated claims about the health benefits of some of its products.
But, clearly influenced by a flood of mail and phone calls from consumers who fear that the regulations could result in many dietary products disappearing from the shelves, a majority of the committee members sided with Hatch’s industry-backed bill. It would require the FDA to disprove a nutritional claim before barring a manufacturer from using it.
The committee “responded to the largest letter-writing campaign and largest outcry in the history of our country. They responded to their constituents,” said Gerald Kessler, executive director of the Nutritional Health Alliance, an industry-led group.
FDA officials had no immediate comment, but FDA Commissioner David A. Kessler argued in testimony before another Senate committee Tuesday that dietary supplements should be governed by the same regulations Congress has already imposed on food products.
Those regulations require that manufacturers meet the “significant scientific agreement” standard before making health claims about their products.
But, noting that the attempt to impose the new restrictions had put the FDA on a collision course with “hundreds of millions consumers (and) their efforts to make themselves healthier,” Hatch argued that “dietary supplements aren’t drugs or food additives and should be protected against arbitrary FDA actions.”
Denying that manufacturers were making false claims about their products, Gerald Kessler, who is not related to the FDA administrator, said safeguards written into the Hatch bill in an attempt to reach a compromise with the FDA would secure “the right of consumers to have access to dietary supplements” while assuring that they are not misled by unsubstantiated advertising.
Critics called the compromise inadequate and argued that it could even lower existing safety standards by restricting the FDA’s authority to bar potentially hazardous products from the shelves of health food stores.
The Hatch bill, as passed by the committee, “opens the floodgates to misleading health claims for at least another three years,” said Bruce Silverglade, a spokesman for the Center for Science in the Public Interest, a public-interest food and nutrition group.
“In addition, the bill lowers safety standards for dietary supplements . . . (because) the FDA could only remove products that pose an imminent danger--not those that pose a potential hazard, such as products that cause allergic reactions,” he said.
In an effort to address some of those concerns, Hatch incorporated a proposal into his legislation that would form a congressionally appointed commission to conduct a two-year study into a more effective process for ruling on manufacturers’ health claims.
He also promised that he would rewrite some of the legislation before it goes to the Senate floor in order to address concerns, voiced by several senators, that his bill would strip the FDA of too much of its authority to safeguard consumer interests.
Kennedy had argued that any easing of the standards could invite some manufacturers of supplements and herbal extracts to dupe customers into buying products with unsubstantiated claims about cures for cancer or AIDS.
But while the senators did not dispute the need for safeguards to prevent abuses, the majority agreed with Hatch that the standards of scientific proof sought by the FDA were both unnecessary and too high for the manufacturers of most dietary supplements to meet.