Key Legal Concepts:
"Adulterated," and "Misbranded"
The Food, Drug, and Cosmetic Act (FD&C Act) prohibits, among other things,
- "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)].
- "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)].
- "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)].
- "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
"(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
"A cosmetic shall be deemed to be adulterated--
- (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.
- (b) If it consists in whole or in part of any filthy, putrid, or decomposed substance.
- (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.
- (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.
- (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--
- the composition of the product itself,
- the conditions under which the product is manufactured, shipped, and stored,
- the product's container, and
- 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
"A cosmetic shall be deemed to be misbranded--
- (a) If its labeling is false or misleading in any particular.
- (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.
- (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.
- (d) If its container is so made, formed, or filled as to be misleading.
- (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
- (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--
- False or misleading information,*
- Lack of required information,
- Conspicuousness and readability of required information,
- Misleading packaging,
- Improper packaging and labeling of color additives, and
- 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.
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--
- requires further label information, such as the product's identity [15 U.S.C.1453], and
- 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].