18 | www.CosmeticsandToiletries.com Vol. 130, No. 7 | September 2015
REGULATORY | C&T
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© 2015 Allured Business Media.
If you stand in a room of regulatory professionals, you can’t mistake the confident demeanor of colleagues who work in prescription drugs and medical devices. Much is the same for foods and sometimes even dietary
supplements. If in a room like this you admit that you work in cosmetics,
they might just look down their noses, wondering why you didn’t make it
into the big leagues.
The truth is, however, that in most jurisdictions, regulators don’t approve
cosmetics the way they do drugs and medical devices. In these latter categories, suppliers get all kinds of help from regulators, from the formulation
to how it’s manufactured to how it’s labelled. Regulators are known to write
volumes to petitioners for these sophisticated kinds of products in order to
guide them to approval.
Cosmetics don’t get this kind of help. Cosmetics land in most markets
on the basis of professional advice from any number of sources. Input can
come from the marketing department, the R&D team, regulatory affairs,
legal, outside consultants and yes, even the art department. Cosmetics don’t
dredge through any regulatory checks and balances until products are on
the shelf or trying to cross international borders. Beyond that, there is no
global harmonization of cosmetic regulations.
While regulations for drugs and medical devices see some global differences, the basic concepts are similar. We’ve often shaken our heads as to
why cosmetic rules are so different from country to country. Now we look
throughout the United States and wonder why they are so different state to
state. Infuriating as this condition is, it gives us some serious bragging rights
in a room full of our pill-pushing regulatory colleagues.
But it really makes you ask, in a world that knows how to regulate
serious products like drugs, why can’t regulation get done for much simpler
products like cosmetics? A majority of the answer to this question lies in
the fact that cosmetics have not historically had anywhere near consistent
interest by regulators.
Challenges of Regulation
Much of today’s serious cosmetic regulation has been set just in the past
20 years. Prior to that, the cosmetics category was a very lightly regulated.
As different jurisdictions have become aware of the importance of cosmetic
Robert Ross-Fichtner and Daniel Noble
Focal Point Research, Inc., Mississauga, Ontario, Canada
Unifying U.S. Cosmetic Regulation
The Challenges of the Personal
Care Products Safety Act
federal • personal care
products • safety • Act •
cosmetic • regulation •
uniformity • consistency
Feinstein • Collins • bill
The Personal Care
Products Safety Act, a
bill introduced this past
April, proposes regulation
of the cosmetics and
personal care industry like
no other legislation since
the U.S. Food, Drug and
Cosmetic Act of 1938.
Perhaps the greatest
issue for it to resolve, or
fail to, is uniformity of that