LONG BEACH, CALIF. -- Dietary supplements will soon bear labels worded a whole lot more like the ones on over-the-counter medications and a whole lot less like the text of infomercials.

In a move designed to protect consumers by requiring that health claims are supported by scientific

The changes come under the provisions of the agency's Consumer Health Information for Better Nutrition Initiative.

Under this initiative, the agency will use evidence-based rankings to evaluate everything from plant-derived tablets purporting to lower cholesterol to "natural" appetite suppressants that promise easy weight loss, J.C. Rowlands, Ph.D., said in a presentation at the annual meeting of the American College of Nutrition.

The FDA embarked on this revision as a result of two simultaneous trends in the last few years: the apparent rise of misleading claims about dietary supplements, and the actual increase of solid research on their potential benefits, said Dr. Rowlands, a scientist for the Center for Food Safety and Applied Nutrition at the FDA.

As a result of the initiative, manufacturers will have to make a stronger case for claims of prevention and symptom relief. Their evidence will be reviewed for scientific soundness by looking not just at how studies were conducted, but how many participants they included and how many different trials occurred. Randomized, placebo-controlled trials top the list. "The [current] evidence-based ranking system defines credible evidence," he explained, adding that "we are looking for consistency."

It has been 10 years since Congress enacted the first such oversight restrictions in its unprecedented Dietary Supplement Health and Education Act, but the battle against its concept began even before the act was signed into law. "Lawsuits began being filed before the ink was even dry," Dr. Rowlands said. Using arguments centered on first-amendment rights, some supplement makers waged successful court battles in favor of language that allowed certain promises on the packaging, such as better heart health or bone growth.

Under the new initiative, several steps are taken to identify the relevant studies underpinning such claims, and the system includes rating those studies based on quality. The research is assessed for "strength" by looking at the number of studies that are available, as well as the similarity--or lack thereof--with in the findings.

There are essentially four ranks for health claims, with the highest level called "significant scientific agreement." The three lower levels are substantiated by less scientific evidence than an SSA claim. As such, they require qualifying language on their labels, Dr. Rowlands said.

Any supplement that claims to reduce the risk for a certain disease in the general population or a targeted subgroup is to be reviewed under the new system. The system is likely to evolve even more, as the research on and manufacture of health-promoting foods and supplements continues to grow.

"We wish we had an exact formula" for evaluation, Dr. Rowlands said. But a precise, black-and-white, all-in-clusive method of assessment has proved elusive in this rapidly changing field, he said.

BY ANNE SCHECK

Contributing Writer