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Feb. 16, 2000 (Washington) -- The FDA's final rule regarding what claims can or can't be made by makers of dietary supplements actually is anything but final, agency officials told industry representatives Wednesday. In a rare public appearance, the federal regulators also said that the agency is planning to hold a public hearing in March to look into the propriety of pregnancy-related claims, and that there are two petitions currently pending that may significantly change how the agency's overall rule is enforced.
The FDA rule, which took effect Feb. 8, significantly expanded the numbers of conditions that dietary supplements could claim to treat without prior FDA approval. But in response to overwhelming concern about the use of untested products by pregnant women, FDA officials on Feb. 10 urged makers of dietary supplements to refrain from making claims regarding morning sickness and leg swelling associated with pregnancy. These claims otherwise would have been permitted under a provision allowing supplement makers to promote products for conditions considered to be normal stages of life.
But the agency's rapid backtracking may now also work in favor of dietary supplement makers, who have several of their own bones to pick with the FDA. Chief among those are a provision that requires all dietary supplements to carry a disclaimer saying that the FDA did not review this labeling claim, and a provision that bans dietary supplements from making so-called implied disease claims. Implied disease claims are claims that purport to treat a condition that is closely linked to the onset of disease, such as when a product claims to lower cholesterol levels.
In terms of the disclaimer provision, a petition was merited because the FDA's new policy sets two different standards for foods and dietary supplements, Stephen McNamara tells WebMD. McNamara, an attorney who once served as senior trial lawyer for the FDA, says the agency's present position also reverses an earlier FDA policy without going through the proper rule-making procedures. But the real problem, he adds, is the lack of any true justification. For example, he asks, "If the FDA is going to let the milk industry make calcium claims without a disclaimer, why not let dietary supplements do it?"
"The FDA has gone too far," agrees Sarah Taylor, RD, MPH, an attorney specializing in food and drug laws. The explicit purpose of the federal legislation that inspired the FDA's final dietary supplement rules was to permit broader claims, including implied disease claims, she says. But under the FDA's current interpretation, manufacturers essentially are forbidden from making any "health" claim, although that benefit can be substantiated.
"We have established different standards for foods and dietary supplements because the authority for foods comes from a different section [of the law]," says Louisa Nickerson, associate chief counsel for foods at the FDA. But when pressed for more specifics regarding implied disease claims, Nickerson refuses to elaborate because of the two pending petitions.
Nonetheless, the agency does feel that it has sufficient regulatory authority to protect consumers from any hazards, Robert J. Moore, PhD, tells WebMD. Moore, who is acting chief of the agency's dietary supplements branch, says the agency is capable of subjecting all dietary supplements to strict post-marketing surveillance. Any more scrutiny, he tells WebMD, "would have to be a matter of public policy." In other words, he says, consumers would have to petition Congress to give the FDA more regulatory authority.
In related news, California State Health Director Diana Bonta, RN, MPH, warned consumers Wednesday to stop using five herbal products because they contain two prescription drugs that were not listed on the label but required physician monitoring. The herbal products are Diabetes Hypoglucose Capsules, Pearl Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Pearl Hypoglycemic Capsules, Tongyi Tang Diabetes Angel Hypoglycemic Capsules, and Zhen Qi Capsules.
The products claim to contain only herbal ingredients, but an investigation by the California Department of Health found that they contain the diabetes drugs glyburide and phenformin, Bonta said. The investigation, she added, was launched after a diabetic patient suffered from several episodes of low blood sugar after consuming one of these products. The patient has since recovered, she said.