Magazine article Drug Topics

FDA to Clarify Claims for Diet Supplements

Magazine article Drug Topics

FDA to Clarify Claims for Diet Supplements

Article excerpt

The Food & Drug Administration has set out to clarify what statements dietary supplement makers may and may not make about their products-a matter considered to involve several gray areas within the burgeoning $5 billion industry.

Under a proposed rule published in the April 29 Federal Register, the agency would consider a product a drug if it is claimed to diagnose, cure, mitigate, treat, or prevent disease. As such, it must meet appropriate safety and effectiveness standards. For example, "protects against cancer," "treats hot flashes," and "reduces nausea associated with chemotherapy" would be deemed disease claims.

A product that is claimed to affect only a body system, organ, or function, however, would not need prior FDA clearance, as provided under the 1994 Dietary Supplement and Health Education Act. For example, "promotes regularity," "helps maintain cardiovascular health," or "supports the immune system" would be permitted.

The FDA defines a disease as "any deviation from, impairment of, or interruption of the normal structure or function of any part, organ, or system of the body that is manifested by a characteristic set of signs or symptoms." It recognizes the potential for confusion in making the distinction between maintaining normal function, "which is potentially the basis for an allowable structure/ function claim," and preventing or treating abnormal function, "which is potentially a disease claim." For example, "maintains healthy cholesterol levels" is considered acceptable, whereas "lowers cholesterol levels" is not. …

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