Feb. 4, 2000 (Washington) -- While it may appear unusual, if not downright ridiculous, to define pregnancy as a disease or abnormal condition, a new FDA rule now has a number of experts imploring the federal agency to seriously consider adopting this definition.
The rule, scheduled to take effect Monday, would permit makers of dietary supplements to market their products for the treatment of morning sickness and fluid retention, two conditions that accompany many pregnancies. The rule basically is a result of the Dietary Supplement Health and Education Act of 1994 (DSHEA), which, when passed, was intended to ensure that consumers could receive adequate information about the effects of dietary supplements on the "structure or function" of their bodies. To facilitate the exchange of this information, the law permitted dietary supplement makers to make these claims without conducting the same clinical trials required of prescription drug makers.
The rule excludes any claims to treat a disease or its symptoms, at which point the product would be considered a prescription drug. But while the FDA historically has applied this exclusion to limit a large number of structure and function claims, last month the agency decided that common symptoms such as morning sickness are structure and function claims. The decision comes in response to a lawsuit that challenged -- based on First Amendment rights -- the FDA's previous limitations.
The agency's move has placed it in a difficult position. "Pregnancy is not a disease," says Jennifer Niebyl, MD, chairwoman of obstetrics and gynecology at the University of Iowa Medical School, in Iowa City. But there are conditions inherent to pregnancy that might affect complications [of the supplements]," she says. And these conditions, she tells WebMD, necessitate the testing of any product given to pregnant women for both safety and effectiveness.
Niebyl is not alone in this belief. "This current policy is an invitation for disaster," says Godfrey Oakley, MD, a professor of epidemiology at the Emory University School of Medicine, in Atlanta. "You shouldn't have a public policy that encourages pregnant women to take a substance that has not been tested for safety," he says. Both Oakley, who is a past director of the division of birth defects at the CDC, and Niebyl add that they have sent separate letters to the FDA stating exactly that.
At present, there are no dietary supplements that carry these claims and, therefore, no imminent danger. But the potential for danger also proves that DSHEA is a failed policy, adds Larry D. Sasich, PharmD, MPH, a spokesperson for the watchdog group Public Citizen. "This whole law is so outrageous," he tells WebMD. Under the current regulation, he explains, a maker of dietary supplements could now market potentially hazardous products to pregnant women, and the FDA could not respond until a side effect emerged, which may not happen for several years.
There are dietary supplements that may prove dangerous when marketed to pregnant women, admits Bill Soller, MD, director of science and technology at the Consumer Products Healthcare Association. However, says Soller, whose association represents the interests of dietary supplement manufacturers, there are also several safeguards built into the regulatory scheme to protect consumers.
"Under the law, we must market safe products," he says. And in order to meet that obligation, a dietary supplement maker must provide a notification at least 75 days prior to making a structure or function claim to the FDA for its review, he tells WebMD. If the FDA is uncomfortable with that claim, he adds, it can ask for scientific data to validate the claim.
The objections raised to the FDA's current policy are a perfect illustration, he says. A group of doctors expressed a specific medical concern, and the FDA probably will now take a look at these concerns, Soller says. But to say that the system is inherently flawed because of a specific concern is taking the issue too far, he tells WebMD. "I will not defend those symptom claims, but I will defend the process," he says.
Oakley also now expresses some reservations. "There ought to be an institute to look at these things," he says. "I believe that there have been several legitimate structural claims based upon sound scientific evidence," he tells WebMD. Nonetheless, he adds, if the policy permits the sale of untested products to pregnant women, then "the current policy is a setup for disaster."