CLAIMS: REGULATORY, OTC
Is there a sizeable regulatory risk looming in
the industry’s near future, or is the industry
itself at risk?
BY MARIE ALICE DIBON
n Although regulatory bodies may
not actively be policing claims,
overstated and druglike claims may
still have negative ramifications for
n Growing consumer expectations
and the increasing interest for
natural and organic products are
among the issues that put more
pressure on world governments to
create new rules and regulations.
n A simple surveillance of the media
that consumers turn to the most
for information on beauty products
is a good first step for the beauty
industry in assessing and altering,
if needed, its approach to claims.
46 Claims: Regulatory, O TC
Every few years, the same question arises: will the U.S. Food and Drug Administration (FDA) ever push to create a “cosmeceuticals” category? The term, widely used
by the industry, has no legitimacy. It
was created to imply that cosmetics are
designed to do more than just beautify, and
somehow treat without really being drugs.
Was the intent of industry, when it began
using that term, to really see a new category
emerge that would have given products
more credibility? If so, did the industry
ever think that the risk of seeing the
U.S. Congress regulate that category was
real? And, in this case, what were we
Yes, there would be grounds for such a
category in the letter of the law, given the
way the U.S. system functions, essentially
based on claims. When a product claims
to repair DNA, impact stem cells or repair
stretch marks or even wrinkles, it is no
longer a cosmetic claim. As shrewd as
certain legal teams may be in making those
claims—managing to not “really” make the
claims yet leaving the implication there that
these are effects of the finished product—
some have been caught at their own game.
But it must be admitted, the actions of
the FDA against such claims, or family of
claims, have remained mild, at best.
In fact, what seems to be driving the
FDA is hardly ever solely the claim and
the deception that some claims represent,
considering that they are often not backed
by solid clinical evidence (no, before-and-after pictures are not solid clinical
evidence) and only in vitro studies.
In the few instances where companies
were actually prosecuted by the FDA, there
seems to have been other interests at play.
A Short Case Study
When consumer safety is at stake, the FDA
acts swiftly. After all, its first priority is
the public’s protection. However, it is not
often the case with the vast majority of
companies making drug claims on their
products. But when it is, the FDA’s actions
do not stop at the standard warning letter.
In the case of one brand’s eyelash
cosmetic, in November 2007, not only was a
warning letter issued but the FDA had more
than 12,000 units of the product seized.
The company stopped manufacturing the
In that case, the product was mislabeled
(the brand made drug claims, i.e. to increase
eyelash growth), it was considered an
adulterated cosmetic (it contained an active
ingredient, bimatoprost, FDA-approved