FDA Mineral Makeup Labeling
Information
Cosmetic Labeling & Label Claims
Overview
April 25, 2006
The following information is a brief introduction to labeling
requirements. For a more thorough explanation of cosmetic
labeling regulations, refer to FDA's
Cosmetic Labeling Manual
and the
regulations themselves (21 CFR parts 701 and 740). Firms
also may wish to discuss their labeling needs with a consultant.
Proper labeling is an important aspect of putting a cosmetic
product on the market. FDA regulates cosmetic labeling under the
authority of both the
Federal Food, Drug, and Cosmetic Act (FD&C Act) and the
Fair Packaging and Labeling Act (FPLA). These laws and their
related regulations are intended to protect consumers from
health hazards and deceptive practices and to help consumers
make informed decisions regarding product purchase.
It is illegal to introduce a misbranded cosmetic into
interstate commerce, and such products are subject to regulatory
action. Some of the ways a cosmetic can become misbranded are:
- its labeling is false or misleading,
- its label fails to provide required information,
- its required label information is not properly
displayed, and
- its labeling violates requirements of the Poison
Prevention Packaging Act of 1970 [FD&C Act, sec. 602; 21
U.S.C. 362].
Does FDA pre-approve cosmetic product labeling?
No. FDA does not have the resources or authority under the
law for pre-market approval of cosmetic product labeling. It is
the manufacturer's and/or distributor's responsibility to ensure
that products are labeled properly. Failure to comply with
labeling requirements may result in a misbranded product.
Some labeling terms you should know
Before proceeding with a discussion of labeling requirements,
it is helpful to know what some labeling terms mean:
- Labeling. This term refers to all
labels and other written, printed, or graphic matter on or
accompanying a product [FD&C Act, sec. 201(m); 21 U.S.C.
321(m)].
- Principal Display Panel (PDP). This is
the part of the label most likely displayed or examined
under customary conditions of display for sale [21 CFR
701.10].
- Information Panel. Generally, this term
refers to a panel other than the PDP that can accommodate
label information where the consumer is likely to see it.
Since the information must be prominent and conspicuous [21
CFR 701.2(a)(2)], the bottom of the package is generally not
acceptable for placement of required information, such as
the cosmetic ingredient declaration.
Is it permitted to label cosmetics "FDA Approved"?
No. As part of the prohibition against false or misleading
information, no cosmetic may be labeled or advertised with
statements suggesting that FDA has approved the product. This
applies even if the establishment is registered or the product
is on file with FDA's
Voluntary Cosmetic Registration Program (VCRP) (see 21 CFR
710.8 and 720.9, which prohibit the use of participation in the
VCRP to suggest official approval). False or misleading
statements on labeling make a cosmetic misbranded [FD&C Act,
sec. 602; 21 U.S.C. 362].
What about therapeutic claims?
Be aware that promoting a product with claims that it treats
or prevents disease or otherwise affects the structure or any
function of the body may cause the product to be considered a
drug. FDA has an Import Alert in effect for cosmetics labeled
with drug claims. For more information on drug claims, refer to
Is It a Drug, a Cosmetic, or Both? (Or Is It Soap?).
How should products be labeled if they are both drugs and
cosmetics?
If a product is an
over-the-counter (OTC) drug as well as a cosmetic, its
labeling must comply with the regulations for both OTC drug and
cosmetic ingredient labeling [21 CFR 701.3(d)]. The drug
ingredients must appear according to the OTC drug labeling
requirements [21 CFR 201.66(c)(2) and (d)] and the cosmetic
ingredients must appear separately, in order of decreasing
predominance [21 CFR 201.66(c)(8) and (d)]. Contact the
Center for Drug
Evaluation and Research (CDER) for further information on
drug labeling.
What languages are acceptable?
All labeling information that is required by law or
regulation must be in English. The only exception to this rule
is for products distributed solely in a U.S. territory where a
different language is predominant, such as Puerto Rico. If the
label or labeling contains any representation in a foreign
language, all label information required under the FD&C Act must
also appear in that language [21 CFR 701.2(b)].
What labeling information is required?
The following information must appear on the principal
display panel:
- An identity statement, indicating the
nature and use of the product, by means of either the common
or usual name, a descriptive name, a fanciful name
understood by the public, or an illustration [21 CFR
701.11].
- An accurate statement of the net quantity of
contents, in terms of weight, measure, numerical
count or a combination of numerical count and weight or
measure [21 CFR 701.13].
The following information must appear on an information
panel:
- Name and place of business. This may be
the manufacturer, packer, or distributor. [21 CFR 701.12].
- Distributor statement. If the name and
address are not those of the manufacturer, the label must
say "Manufactured for..." or "Distributed by..." [21 CFR
701.12].
- Material facts. Failure to reveal
material facts is one form of misleading labeling and
therefore makes a product misbranded [21 CFR 1.21]. An
example is directions for safe use, if a product could be
unsafe if used incorrectly.
- Warning and caution statements. These
must be prominent and conspicuous. The FD&C Act and related
regulations specify warning and caution statements related
to specific products [21 CFR part 700]. In addition,
cosmetics that may be hazardous to consumers must bear
appropriate label warnings [21 CFR 740.1]. An example of
such hazardous products is flammable cosmetics.
- Ingredients. If the product is sold on
a retail basis to consumers, even it it is labeled "For
professional use only" or words to that effect, the
ingredients must appear on an information panel, in
descending order of predominance. [21 CFR 701.3]. Remember,
if the product is also a drug, its labeling must comply with
the regulations for both OTC drug and cosmetic ingredient
labeling, as stated above.
Information above copied with permission of the FDA.gov
website
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