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
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
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 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.