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Rx for supplement labels: a mixed prescription

Agency gives new leeway for disease prevention claims but imposes some significant restrictions, too.

The Nutrition Farm's Herbal Serenity label (left) refers to the use of
The Nutrition Farm's Herbal Serenity label (left) refers to the use of

Dietary supplement manufacturers will have greater freedom to make disease prevention claims on their product labels as a result of the rule the U.S. Food & Drug Administration issued in January. But initial press accounts that portrayed the new rule as a major victory for the industry were a bit over the top.

While FDA appears to be offering companies some leeway, there is enough “gray” in the rule to make it a candidate for Grecian Formula.

Annette Dickinson, vice president of scientific and regulatory affairs at the Council for Responsible Nutrition, says FDA made some improvements in the final rule compared to the proposed rule, which came out in April 1998. But the agency took at least one major step backwards. It also threw in a “bombshell.”

The final rule issued on Jan. 6 distinguishes between “function/structure” claims and “disease” claims. The former are allowed without any FDA prior approval. But labels have to include a disclaimer: “This product is not intended to diagnose, treat, cure or prevent any disease.”

The disclaimer, however, is not required on products whose claims are well-recognized in scientific literature, such as “Vitamin C builds strong bones.”

Disease claims are a different story. If a company wants to make a disease claim such as “protective against the risk of the development of cancer,” it must obtain FDA approval. To secure that approval, the company has to show that the disease claim is backed by “significant scientific agreement” among qualified experts and that the claim is supported by the totality of publicly available scientific evidence.

Marketing tools

Manufacturers of dietary supplements would much prefer to make disease claims because they are more potent marketing tools than function/structure claims. The final rule does give them more wiggle room here. Currently, FDA uses a “disease” definition developed in 1993 as an outgrowth of the Nutrition Labeling and Education Act. A key aspect of that definition is that for a condition to be considered a disease there has to be “damage to an organ, part, structure or system of the body such that it does not function properly. . . or a state of health leading to such dysfunctioning. . .” In essence, the definition restricts the number of conditions FDA considers diseases, allowing supplement companies to make function/structure claims for conditions that others might have considered diseases.

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