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What is False Private Label Mineral Makeup, Cosmetics, and Skin
Care?
Answer via the FDA.gov
Key Legal Concepts: "Interstate Commerce," "Adulterated," and
"Misbranded"
February 9, 2006
The
Federal Food, Drug, and Cosmetic Act
(FD&C Act) prohibits, among other things,
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"The introduction or delivery for introduction into
interstate commerce of any food, drug, device, or cosmetic
that is adulterated or misbranded" [FD&C Act, sec. 301(a);
21 U.S.C. 331(a)].
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"The adulteration or misbranding of any food, drug, device
or cosmetic in interstate commerce" [FD&C Act, sec. 301(b);
21 U.S.C. 331(b)].
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"The receipt in interstate commerce of any food, drug,
device, or cosmetic that is adulterated or misbranded, and
the delivery or proffered delivery thereof for pay or
otherwise"[FD&C Act, sec. 301(c); 21 U.S.C. 331(c)].
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"The alteration, mutilation, destruction, obliteration, or
removal of the whole or any part of the labeling of, or the
doing of any other act with respect to, a food, drug,
device, or cosmetic, if such act is done while such article
is held for sale (whether or not the first sale) after
shipment in interstate commerce and results in such article
being adulterated or misbranded" [FD&C Act, sec. 301(k); 21
U.S.C. 331(k)].
This means that nearly everyone involved in cosmetics in
interstate commerce, such as manufacturers, packers,
distributors, and retailers, is responsible for assuring that he
or she is not dealing in products that are adulterated or
misbranded, even if someone else caused the adulteration or
misbranding in the first place. If you introduce it into
interstate commerce or receive it in interstate commerce, you
are responsible. The law applies to components and packaging as
well as to finished products.
The FD&C Act describes what constitutes interstate commerce,
adulteration, and misbranding. It also authorizes FDA to take
legal action if cosmetics are adulterated or misbranded. In
addition, the Fair Packaging and Labeling Act (FPLA) requires
specific label information. Violations of the FPLA result in
misbranding.
What does the FD&C Act mean by interstate commerce?
Section 201(b) of the FD&C Act [21 U.S.C. 321(b)] tells what
circumstances place a product in interstate commerce:
"(1) commerce between any State or Territory and any place
outside thereof, and
(2) commerce within the District of
Columbia or within any other Territory not organized with a
legislative body."
"Interstate commerce" applies to all steps in a product's
manufacture, packaging, and distribution. It is very rare that a
cosmetic product on the market is not in "interstate commerce"
under the law. For example, at least some of your ingredients or
packaging most likely originate from out of state, or even out
of the country. Likewise, it is foreseeable that your products
will leave the state. Although there are certain exemptions [21
CFR 701.9], factors such as these generally cause the
requirements of the FD&C Act to apply to your products.
What makes a cosmetic adulterated?
Section 601 of the FD&C Act [21 U.S.C. 361] describes what
causes a cosmetic to be considered adulterated:
"A cosmetic shall be deemed to be adulterated--
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(a) If it bears or contains any poisonous or deleterious
substance which may render it injurious to users under the
conditions of use prescribed in the labeling thereof, or,
under such conditions of use that are customary or usual,
except that this provision shall not apply to coal-tar hair
dye, the label of which bears the following legend
conspicuously displayed thereon: "Caution-This product
contains ingredients which may cause skin irritation on
certain individuals and a preliminary test according to
accompanying directions should first be made. This product
must not be used for dyeing the eyelashes or eyebrows; to do
so may cause blindness.", and the labeling of which bears
adequate directions for such preliminary testing. For the
purposes of this paragraph and paragraph (e) the term "hair
dye" shall not include eyelash dyes or eyebrow dyes.
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(b) If it consists in whole or in part of any filthy,
putrid, or decomposed substance.
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(c) If it has been prepared, packed, or held under
insanitary conditions whereby it may have become
contaminated with filth, or whereby it may have been
rendered injurious to health.
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(d) If its container is composed, in whole or in part, of
any poisonous or deleterious substance which may render the
contents injurious to health.
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(e) If it is not a hair dye and it is, or it bears or
contains, a color additive which is unsafe within the
meaning of section 721(a)." (Section 721(a) of the FD&C Act
[21 U.S.C. 379(a)], states the circumstances under which
color additives are deemed unsafe.)
Note that the law addresses--
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the composition of the product itself,
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the conditions under which the product is manufactured,
shipped, and stored,
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the product's container, and
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an exception for coal-tar hair dyes.
What makes a cosmetic misbranded?
Section 602 of the FD&C Act [21 U.S.C. 362] describes what
causes a cosmetic to be considered misbranded:
"A cosmetic shall be deemed to be misbranded--
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(a) If its labeling is false or misleading in any
particular.
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(b) If in package form unless it bears a label containing
(1) the name and place of business of the manufacturer,
packer, or distributor; and (2) an accurate statement of the
quantity of the contents in terms of weight, measure, or
numerical count: Provided, That under clause (2) of this
paragraph reasonable variations shall be permitted, and
exemptions as to small packages shall be established, by
regulations prescribed by the Secretary.
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(c) If any word, statement, or other information required by
or under authority of this Act to appear on the label or
labeling is not prominently placed thereon with such
conspicuousness (as compared with other words, statements,
designs, or devices in the labeling) and in such terms as to
render it likely to be read and understood by the ordinary
individual under customary conditions of purchase and use.
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(d) If its container is so made, formed, or filled as to be
misleading.
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(e) If it is a color additive, unless its packaging and
labeling are in conformity with such packaging and labeling
requirements, applicable to such color additive, as may be
contained in regulations issued under section 721. This
paragraph shall not apply to packages of color additives
which, with respect to their use for cosmetics, are marketed
and intended for use only in or on hair dyes (as defined in
the last sentence of section 601(a)).
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(f) If its packaging or labeling is in violation of an
applicable regulation issued pursuant to section 3 or 4 of
the Poison Prevention Packaging Act of 1970.
Note that under the FD&C Act, the term "misbranding"
applies to--
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False or misleading information,*
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Lack of required information,
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Conspicuousness and readability of required information,
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Misleading packaging,
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Improper packaging and labeling of color additives, and
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Deficiencies where the Poison Prevention Packaging Act
requires special packaging.
*Note: According to the FD&C Act, a determination that labeling
is "misleading" includes considering both what the label says
and what it fails to reveal:
"If an article is alleged to be misbranded because the labeling
or advertising is misleading, then in determining whether the
labeling or advertising is misleading there shall be taken into
account (among other things) not only representations made or
suggested by statement, word, design, device, or any combination
thereof, but also the extent to which the labeling or
advertising fails to reveal facts material in the light of such
representations or material with respect to consequences which
may result from the use of the article to which the labeling or
advertising relates under the conditions of use prescribed in
the labeling or advertising thereof or under such conditions of
use as are customary or usual" (FD&C Act, sec. 201(n); 21 U.S.C.
321(n)].
In addition, a cosmetic marketed in violation of the
FPLA or any regulations issued under its authority is considered
misbranded within the meaning of the FD&C Act [15
U.S.C.1456(a)]. For cosmetics offered for sale as consumer
commodities, the FPLA--
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requires further label information, such as the product's
identity [15 U.S.C.1453], and
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authorizes the implementation of regulations to specify the
proper presentation of required label information, require
an ingredient declaration, and prevent deceptive packaging
[15 U.S.C.1454 (c)]
The FPLA defines a consumer commodity, as it applies to
FDA-regulated products, as:
"any food, drug, device, or cosmetic (as those terms are defined
by the Federal Food, Drug, and Cosmetic Act ..., and any other
article, product, or commodity of any kind or class which is
customarily produced or distributed for sale through retail
sales agencies or instrumentalities for consumption by
individuals, or use by individuals for purposes of personal care
or in the performance of services ordinarily rendered within the
household, and which usually is consumed or expended in the
course of such consumption or use." [15 U.S.C.1459(a)]
Note that the FPLA defines a consumer commodity by the way it is
marketed, not the way it is labeled. Labeling a product with
words such as "For Professional Use Only" does not keep your
product from being considered a consumer commodity under the
FPLA.
Labeling regulations are very complex. Detailed information on
cosmetic labeling is available in FDA's
Cosmetic Labeling Manual and
the
labeling regulations
themselves [21 CFR 701].
Information above copied with permission of the
FDA.gov website
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