Supplement Claims for Pregnancy Symptoms: Confusion Reigns
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."