Roanoke Times
Copyright (c) 1995, Landmark Communications, Inc.
DATE: SATURDAY, November 27, 1993 TAG: 9311270121
SECTION: NATIONAL/INTERNATIONAL PAGE: A-1 EDITION: METRO
SOURCE: By Los Angeles Times
DATELINE: WASHINGTON LENGTH: Medium
Their writers fear proposals by the Food and Drug Administration to place restrictions on the sale of vitamins and dietary supplements that the government believes promise more results than warranted.
Critics of the plan contend the FDA is undertaking a power grab that will make it harder for consumers to buy some substances in quantities they have become accustomed to, such as heavy doses of vitamin C to fight colds. They have lined up impressive scientific support for their side and instigated the barrage of letters to try to head off the FDA.
But the protest fell short of its goal, at least temporarily, when Congress adjourned Friday without approving a proposed moratorium to delay FDA action. The Senate passed a bill postponing the FDA's proposals until next spring, but House members went home for the year without acting on it.
As a result, the FDA is free to put into effect formal regulations Dec. 15 dictating the kinds of claims that manufacturers may make to sell vitamins and food supplements. Critics contend this will result in abuses of consumer rights.
"For decades, the FDA has attempted to limit free speech and access to supplements by seizing products, raiding health clinics and insisting that the dissemination of information is tantamount to practicing medicine without a license," said Candace Campbell, spokeswoman for Citizens for Health, one of several advocacy groups opposing the FDA proposals.
Declaring "there's a strong anti-supplement bias at the agency," Campbell said the rules will give FDA "pre-approval power over substances that have been used safely for literally thousands of years . . . and ultimate authority over what manufacturers and even health food store clerks can tell consumers."
FDA officials accuse the critics of exaggeration, arguing that the agency's primary goal is truthful labeling and that consumers' access to dietary supplements "will not be affected one way or another."
If the government ruled that a product label promised a cure not supported by scientific evidence, "all the manufacturer would have to do is simply put the product on the shelf without the unsupportable claim on the label," said Mitch Zeller, an FDA special assistant.
"This debate is not about One-a-Day Vitamins," Zeller said. "For the most part, those products are safe and are not marketed with unsupportable health claims."
Rather, he said, the FDA is primarily concerned about medicinal herbs, amino acids and exotic products such as shark cartilage that raise legitimate questions about safety and labeling.
Critics say the FDA has indicated it will seek to limit the potency of nutrients to about the level found in foods. The result, they say, could be significant: Vitamin C might be available in stores only at dosage levels no greater than the amount of the vitamin contained in one orange, for instance. If a person wanted to take 1,000 milligrams of vitamin C to fight a cold, he might have to take 16 or 17 tablets containing only 60 milligrams each.
An estimated 60 million Americans take vitamins, minerals and other food supplements daily, and 100 million use them occasionally. Sales of supplements total an estimated $4 billion a year.
The FDA wants to reclassify all amino acids as prescription drugs. It also wants to bar the makers of hundreds of traditionally used herbs and supplements from making therapeutic claims unless they seek approval to market the products as drugs.
Sen. Orrin Hatch, R-Utah, has criticized the agency's objectives as unduly burdensome, noting that drug approvals can take up to three years and cost an average of $250,000 for manufacturers. Hatch, along with Rep. Bill Richardson, D-N.M., has sponsored a bill to create a less rigid regulatory regime for supplements.
The legislation would maintain the FDA's existing authority to take action against poisonous or harmful substances. But it endorses the use of "safe dietary supplements" to reduce the nation's health care costs, and makes clear that vitamins, minerals, amino acids and herbs are not "food additives" or "drugs" that would require an expensive and time-consuming government review process.
by CNB