FDA: Vitamin Claims Must Be Backed Up

Acting amid extraordinary controversy, the Food and Drug Administration Wednesday issued final regulations requiring makers of vitamins and dietary supplements to provide scientific evidence backing up health claims they make after July 1.

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 must now 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 or 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 could restrict public access to many supplements.

FDA Commissioner David A. Kessler 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.

Nevertheless, Congress is expected to consider and probably pass legislation to modify the impact of the regulations 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 G. 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.

“It’s very clear there will have to be legislative initiatives,” said J. B. Cordaro, president of the Council For Responsible Nutrition, an industry group. “We think Congress should give FDA more specific directives on evaluating scientific evidence for health claims.”

Congress required the FDA to regulate supplement labels under a 1990 law. But Capitol Hill has been deluged with mail and telephone calls on the issue, generated primarily by manufacturers’ arguments that FDA regulators intended to take away vitamins and other supplements used daily by an estimated 60 million Americans and consumed occasionally by 100 million.

A nationally televised advertisement depicted actor Mel Gibson in his bathroom, shocked to see an FDA inspector seizing vitamins from the medicine cabinet. Supporters of the FDA said the advertisement was typical of scare tactics that produced a heavy volume of anti-FDA mail to members of Congress.

Industry officials praised the FDA for delaying until July 1, 1995, the regulation requiring nutrition information on labels for dietary supplements. Manufacturers had claimed the industry would have to pay more than $100 million for such tasks as relabeling products already on market shelves to comply with the new standard if the effective date was mid 1994.

“This (delay) is certainly positive,” said Cordaro. He said his organization has agreed to work with the FDA to develop consumer research data that would help carry out the regulation.

FDA officials have said that if the government determined that a product label promised a cure not supported by scientific evidence, the manufacturer would still be free to sell the product without making the questionable claim.

“This debate is not about One-a-Day vitamins,” Mitch Zeller, a special assistant for FDA policy, said last fall. “For the most part those products are safe and are not marketed with unsupportable health claims.”

In a related ruling effective immediately, the FDA said it would allow makers of dietary supplements to claim that folic acid may reduce the risk of certain congenital disabilities.

A number of studies have shown that folic acid, one of the B vitamins, can reduce the number of children born with neural tube disabilities, such as spina bifida. A March of Dimes statement said that women taking folic acid prior to conception and during the early weeks of pregnancy can prevent an estimated 50% to 70% of brain and spine disabilities at birth.

But the FDA barred claims touting the effects of dietary fiber on cancer or cardiovascular disease; of antioxidant vitamins on cancer; of omega-3 fatty acids on coronary heart disease, and of zinc on immune deficiency in elderly persons.

The FDA added, however, that it was awaiting a major study expected to be completed early in 1994 on possible health benefits of antioxidant vitamins. A growing body of research indicates some antioxidant vitamins--C, E and beta carotene, a form of Vitamin A--can play a role in preventing heart disease, certain kinds of cancer and other conditions.

The agency acted two days before the end of the year, the deadline Congress gave the FDA to issue final regulations.

Beware of the Sales Pitch

The Food and Drug Administration wouldn’t say Wednesday which companies may have to change their labels under new regulations of dietary supplements. But in a report to Congress last summer, the agency said hundreds of products make unsubstantiated claims, including:

* Garlic: Inhibits growth of viruses.

* Yucca: Helps fight arthritis and gout.

* Hawthorn: Stops hardening of the arteries, lowers blood pressure.

* White Oak Bark: Removes kidney stones, helps varicose veins, douche for vaginal infections.

* Shark Cartilage: Eradicates cancerous tumors.

* Parsley: Removes small kidney stones.

Source: Associated Press