Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: THURSDAY, December 30, 1993 TAG: 9312300233
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
SOURCE: Los Angeles Times
DATELINE: WASHINGTON LENGTH: Medium
The FDA said dietary supplements of vitamins, minerals, herbs or other nutritional substances will be subject to the same requirements for making health claims that now apply to most foods.
"A health claim touting the relationship between a substance and a disease or health-related condition must be supported by significant scientific agreement among qualified experts," the FDA said.
The regulations also will require manufacturers to list the nutrients in their supplements, just as food manufacturers now must provide on food labels. In a bow to manufacturers, however, the agency postponed the effective date of that rule to mid-1995.
The rules place strong new controls on an industry whose less reputable members make unsupported claims about the benefits of such supplements as medicinal herbs, amino acids and exotic substances in preventing cancer, curing AIDS, thwarting hair loss or promoting virility. But it also means higher costs and more requirements for all manufacturers, most of whom the FDA concedes are legitimate.
Industry groups lobbied hard against the rules, arguing that they would force manufacturers to pay for expensive tests and would restrict public access to many supplements, possibly requiring prescriptions for common vitamins.
FDA Commissioner David A. Keller has agreed the tests will be expensive. But on Wednesday he specifically denied that the regulations will limit the availability of legitimate products.
"These rules enable the public to make informed choices," Kessler said in statement accompanying the new rules. "They will not restrict access."
The agency's announcement emphasized that the regulations would ensure that claims made on labels, in catalogues or implied in a product's catchy name are truthful and scientifically valid.
"This is the standard Congress established for health claims on labeling of conventional foods," Kessler said. "It's a flexible standard that will keep unsubstantiated claims out of the marketplace."
Nevertheless, Congress is expected to consider and probably pass legislation to modify the regulations' impact on the $4 billion dietary supplement industry.
Senate and House sponsors of legislation to limit the FDA's authority over dietary supplements had urged postponement of any FDA regulations until Congress decides what to do about the hotly disputed issue.
Sen. Orrin Hatch, R-Utah, principal backer in the Senate, and Rep. Bill Richardson, D-N.M., main House sponsor of the bill, have indicated they will seek early consideration of their measure in both chambers next year.
by CNB