Congress Fails to Halt Curbs on Vitamin Labels

Congress adjourned Friday without imposing a moratorium on the Food and Drug Administration’s plan to restrict the sale of vitamins and dietary supplements that promise more results than the government believes is warranted.

As a result, the FDA is free to promulgate formal regulations on Dec. 15 dictating the kinds of claims that manufacturers may make to sell vitamins and food supplements. Such regulations could 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.

But opponents of the proposed FDA rule-making said it will take six months, or until next June, for any new rules to take effect. By then, Congress may have voted to ease whatever restrictions have been promulgated.

Sponsors of a bill to create a less rigid regulatory regime for supplements--Sen. Orrin G. Hatch (R-Utah) and Rep. Bill Richardson (D-N.M.)--said they will seek early action by both chambers in January when Congress reconvenes.

The Senate already had passed a bill postponing the FDA’s proposals until next spring, but House members went home for the year without acting on it.

Critics of the FDA plan, who deluged Washington with protesting letters, contend the floodgates to consumer-rights abuses will open if the FDA prevails.

“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 that “there’s a strong anti-supplement bias at the agency,” Campbell said the new 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.”

Among those who have encouraged a consumers’ protest are stores that sell vitamins and other food supplements.

At Mother’s Market and Kitchen outlets in Costa Mesa and Huntington Beach, employees have been gathering about 1,800 signatures on petitions weekly since August and forwarding them to Citizens for Health, said employee Lisa Mayer. The stores have also been giving customers sample letters and the phone and fax numbers of congressional representatives and FDA officials. Finally, Mayer said, the stores are continuously running a 50-minute video “to counteract FDA propaganda.”

Clark Anthony Leidenfrost, owner of Tony’s Nutrition in Santa Ana, said he believes the FDA is trying to persuade people to eat well instead of consuming supplements. But he said that message is flawed.

“They are trying to say ‘just buy good food.’ But there is very little good food,” he objected. “We are the greatest food producers in the world, but it is with the use of chemicals and other things that rob the food of its nutrition.”

FDA officials accuse the critics of exaggerated rhetoric, 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, a special assistant for FDA policy.

“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 like shark cartilage that raise legitimate questions about safety and labeling.

Critics say that 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.

The stakes in the dispute are high. 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.

Hatch 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 Richardson, has sponsored a bill to create a less rigid regulatory regime for supplements.

Sen. Barbara Boxer (D-Calif.), who co-sponsored Hatch’s bill to postpone FDA action, said she received “several thousand” letters in a recent two-week period from constituents concerned that the FDA would unduly impede their free choice in buying vitamins and other dietary supplements.

The legislation authored by Hatch and Richardson would instead 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.

Rep. Elton Gallegly (R-Simi Valley) joined Richardson in the House in introducing legislation to limit FDA authority. It is no coincidence that California, Utah and New Mexico all have high concentrations of both consumers and suppliers of vitamins and supplements.

FDA Commissioner David A. Kessler told Congress last summer that his agency has “very little data,” and therefore must “insist on rigorous testing” to determine the effectiveness of vitamins.

While conceding that the cost of FDA efficacy trials for health claims would be huge, Kessler said that “somebody’s going to have to fund the research to do that.” He said his agency wants to eliminate “snake-oil salesmen” from the diet supplement industry, but “for the vast majority of vitamins and minerals we have no problem.”

Legally, Kessler is seeking to bring supplements under the 1990 Nutritional Labeling and Education Act, which sets standards for labels on virtually all processed foods.

Times staff writer Leslie Berkman contributed to this story.