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Chapter 6: Understanding Label Claims

Two types of claims can be made for product performance: drug claims and cosmetic claims. Drug claims are those claims which state that the product alters the physiology or function of any part of the human body. Cosmetic claims do not describe any physiological effect on the body.

For example, "reduces perspiration" is a drug claim for antiperspirant because it states that the product will alter the natural perspiration process. "Dries quickly" is a cosmetic claim because it describes the product but does not indicate any physiological effect on the human body.

A sunscreen might be marketed as a product that "prevents erythema caused by the sun (sunburn)." That is a drug claim. "Unfragranced," however, is a cosmetic claim.

These examples show a clear division between drug claims and cosmetic claims. Actually, however, there is a gray area where drug claims and cosmetic claims may overlap. That is why the U.S. Food and Drug Administration monitors product claims to determine whether any given claim is a drug claim or a cosmetic claim.

In recent years, the overlap between drug claims and cosmetic claims has become more problematic. Basic research has discovered previously unknown physiological effects of accepted cosmetic ingredients, and cosmetic companies have become more aggressive in developing a cosmeceutical approach to marketing. Many cosmetic ingredients can in fact result in temporary changes in the structure and function of the skin. Claims for these changes might be considered drug claims by definition. However, because these changes result from application of accepted cosmetic ingredients used in an ordinary cosmetic situation, they should logically be considered cosmetic claims.

Drug Claims

A company can make a drug claim only after the FDA approves the claim. The FDA has the authority to force a company to remove its product from the store shelves if any drug claim is made about the product without prior agency approval. Or, when consumer safety is at risk, the FDA itself can seize the product.

There are two general categories for FDA drug claim approval. The first applies to all products within a given class of over-the-counter products. The FDA issues a monograph on the class, and OTC products can be marketed with drug claims that adhere to the restrictions set forth in the monograph. For example, any antifungal product containing an effective level of an active ingredient approved in the OTC antifungal monograph can make the claim "cures athlete's foot." This is an approved efficacy claim based on the proven effect of the active ingredient.

The second category for FDA drug claim approval is for claims which do not fall within an approved OTC monograph. These are approved (or not approved) only after an extensive review by the FDA. If a company wishes to make a drug claim for a product beyond the claims approved in the monograph for that product category, then it must submit an Investigative New Drug application. After an exhaustive clinical study, the FDA will review the claim and determine whether it is approved for marketing purposes.

Cosmetic Claims

Cosmetic claims are reviewed by the National Advertising Division of the Council of Better Business Bureaus. The NAD reviews questionable claims reported by consumers and by companies in competition with the company making the questionable claim. On occasion, the NAD may review unreported claims that the agency itself views as questionable. In 1993, it reviewed 12 cases; in 1994, it reviewed 19.

NAD's task is to determine if advertising claims are substantiated by data submitted by the company to support those claims. NAD will make one of three determinations: either the claim is substantiated, or it must be modified based on available scientific information, or advertising based on the claim must be discontinued because the claim is unsubstantiated.

For example, in August 1994, NAD recommended that one company discontinue its claim, "beautiful skin in four days." The claim was unsubstantiated because the company could not supply data supporting the claim. When challenged, some companies will willingly discontinue questionable claims. If a company disagrees with an NAD decision, however, it can appeal to the National Advertising Review Board.

Superiority claims are a source of difficulty. This difficulty arises when two or more cosmetic products each claim superiority in the same performance attribute. For example, one skin cleanser says it is milder than a second, while the second claims to be milder than the first. NAD may allow both claims, but only if the competing companies can each supply scientific data supporting their mildness claims.

Suppose the first company conducted a clinical study in which subjects were asked to evaluate mildness. As a group, the subjects responded that the first product was milder because they experienced less dryness. In a separate clinical study conducted by the second company, its product was found to induce less irritation than the first product. In this case, both the competing claims are correct, both are supportable and both would likely be allowed by NAD.

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