Symphany Rochford
Business Law
May 8, 2017
FDA Authority Over Cosmetics: How Cosmetics are not FDA approved but FDA-
regulated.
The FDA holds the responsibility of protecting public health through the control
and supervision of various products (i.e. food, tobacco, vaccines, over the counter
pharmaceutical drugs, medical devices etc.). Many of these products require FDA
approval before they are allowed to go on the market. There is a different case however,
regarding cosmetics. The law does not require cosmetic products, as well as their
ingredients, to have FDA approval prior to entering the market. The one exception is if
the product contains a color additive, which in that case, the color additive itself would
require approval. This may raise questions about the safety of cosmetics in general.
Although cosmetics do not require pre-approval, there are laws and regulations that apply
to cosmetics on the market in interstate commerce. Companies and individuals who
market cosmetics have a moral obligation and legal responsibility to ensure the safety of
their products. They should ensure that the products are safe when used as directed in
their label or under customary conditions of use. The FDA has regulations in place to
ensure that companies are adhering to their legal responsibilities.
How does the law define a cosmetic?
Before discussing the FDA’s regulation of cosmetics in further detail, it is
important that “Cosmetic” is clearly defined. A product is classified by law, as a drug or
cosmetic depending on what its intended use is. There are different laws in place for
drugs than there are for cosmetics. Companies and individuals sometimes violate the law
by marketing a cosmetic with a drug claim or marking drugs as cosmetics.
According to the FDA, cosmetics are defined by their intended use, as “ articles
intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise
applied to the human body …for cleansing, beautifying, promoting attractiveness, or
altering the appearance”[FD&C, sec.201 (i)]. In terms of this definition, a cosmetic
covers a broader spectrum of products. For example, perfumes, deodorants, shampoos,
lotions and moisturizers, etc.
On the other hand, “ drugs” are defined as “articles intended for use in the
diagnosis, cure, mitigation, treatment or prevention of disease or articles intended to
