Using Caution With Under-regulated Supplements

Auburn, Sept. 17, 2003 --- Aside from being grossly under-regulated and fraught with potential health risks, supplements are also not subjected to the same rigorous research standards as over-the-counter and prescription drugs – yet another reason why consumers should be wary of these products, argues one expert.

Under current regulations, FDA is virtually powerless to take action against supplement manufacturers until someone is actually harmed by using them, according to Dr. Robert Keith, an Alabama Cooperative Extension System nutritionist and Auburn University professor of nutrition and foods.

This lack of strong regulatory oversight, Keith believes, has sparked a “supplement free-for-all,” one in which many supplement manufacturers make outlandish claims about health benefits of their products in an attempt to outdo the competition.

“Granted, there are some loosely written rules about quality and what should go into the product,” he said. “But no one has set a standard for the industry. Certainly no one is closely overseeing them from a regulatory standpoint, though some companies do a better job policing themselves than others.”

Even in cases where supplement manufacturers use scientific research to bolster their claims, the findings should be taken with a grain of salt, Keith said.

“We have scientists in universities and clinical settings employing rigorous research methods. But, generally speaking, the supplement industry doesn’t employ these kinds of methods. Their research not only is lacking in rigor and high standards but is seldom published in peer-reviewed, refereed journals.”

On the other hand, industry-related research findings associated with supplements may occasionally turn up in abstracts presented at professional meetings --- findings that supplement processors then pass off as published research, Keith said.

As part of a cleverly crafted strategy to mislead consumers, some supplement manufacturers also have begun publishing their own journals. Some even offer grant money to legitimate researchers, but with the proviso that they maintain control over the entire research, Keith said.

Yet another approach is to fund mainstream researchers and to encourage them to publish their findings in peer-reviewed journals of their choosing. But even then, the supplement manufacturer retains complete control over how these results are to be advertised after publication --- a problem that often translates into all sorts of mischief, Keith said.

“For example, you may have cases where the legitimate researchers determine that some herbal supplement appears to improve eyesight among some users by, say, one unit of measurement, even though this improvement is not considered statistically significant and may not even be the major point of the peer-reviewed article,” Keith said.

“But since the supplement manufacturer has complete control of the findings following the peer-reviewed publication, it may distort these facts by claiming that the product actually ended up doubling improvement in eye sight, by moving from one to two units.

“If scientists find something the supplement manufacturer doesn’t want, it may try and suppress it, twist it around or pressure the scientist in some way. That’s why mainstream scientists have to be careful.

“They’re using data in ways scientists never imagined it would be used, and they’re doing it legally.”

Within the current federal regulatory environment, removing supplement products off market shelves remains very difficult, even in instances where they have caused long-term health problems or death, Keith said.

One notable example is ephedra, touted as a weight-loss product, which already has been linked with more than 100 deaths.

“Even after all of this has come to light, it’s still on the market. Yes, it probably will eventually be pulled off market shelves, but it has taken a very long time to get this far,” Keith said.

(Source: Dr. Robert Keith, Alabama Cooperative Extension System Nutritionist and Auburn University Professor of Nutrition and Foods, 334-844-3273.)

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