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When Is a Supplement Safe and Effective?

Regulations: Makers can claim their product can treat or prevent an ailment when the feds say they can. Increased interest has turned up the pressure on quickening the process.

September 22, 1997|SHARI ROAN, TIMES HEALTH WRITER

You're a hip health nut, right?

Perhaps you're taking vitamin E to help prevent heart disease.


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Maybe some folic acid supplements to keep the old ticker healthy.

And, possibly, you pop a selenium supplement each day to lower your cancer risk.

After all, widely publicized scientific evidence shows that each of these vitamins or minerals has an effect on preventing or treating disease. The problem is that, many health experts say, not enough evidence exists at this moment to warrant consumers' use of these substances for the treatment or prevention of disease.

Yes, the evidence for a positive health effect is good--just not good enough to support a public policy recommendation for use.

Just how much evidence is needed for consumers to feel confident that a nutritional supplement is safe and effective? That is the profoundly complex question that scientists, government regulatory officials and nutrition-supplement manufacturers are wrestling with as interest in the health effects of vitamins, minerals and herbs soars.

At present, the U.S. Food and Drug Administration allows health claims to be made regarding only a few supplements: calcium for its role in helping prevent osteoporosis and folic acid for its effect on helping to prevent birth defects of the spinal cord.

But as public and professional interest in supplements grows (there's even a new term for foods or nutritional supplements that carry medical-health benefits--"nutraceutical") there is increasing pressure on manufacturers and health officials to quickly clarify the value of a given supplement that is already making headlines.

This struggle was at the heart of the annual conference of the Council for Responsible Nutrition, a supplement-manufacturers' trade organization, last week in Dana Point.

"Our industry is more visible than ever before," said John Cordero, president and chief executive officer of CRN. "This brings an unprecedented level of public trust. Consumers demand to know that our products work."

According to Cordero, the majority of supplement manufacturers is eager to see scientists declare the medicinal value of their wares. Supplement manufacturers are permitted by law to make "nutrition support statements" regarding their products. These statements can address modest facts, such as how the supplement functions in the body, says Annette Dickinson, director of scientific and regulatory affairs for CRN.

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