With the important exception of color additives that are not coal-tar hair dyes, cosmetic
ingredients are not subject to FDA premarket approval authority. However, regulations
prohibit the use of some substances and restrict the use of others because of safety
concerns or environmental factors. Violating the restrictions on the use of these
substances may cause FDA to pursue regulatory action.
What ingredients are prohibited by regulation?
Regulations specifically prohibit or restrict the use of the following ingredients in
cosmetics. For complete details, refer to the regulations (21 CFR, Parts
250.250 and 700.11 through
- Bithionol. The use of bithionol is prohibited because it may cause photo-contact
sensitization (21 CFR 700.11).
- Chlorofluorocarbon propellants. The use of chlorofluorocarbon propellants
(fully halogenated chlorofluoroalkanes) in cosmetic aerosol products intended for
domestic consumption is prohibited (21 CFR 700.23).
- Chloroform. The use of chloroform in cosmetic products is prohibited because
of its animal carcinogenicity and likely hazard to human health. The regulation
makes an exception for residual amounts from its use as a processing solvent
during manufacture, or as a byproduct from the synthesis of an ingredient
(21 CFR 700.18).
- Halogenated salicylanilides (di-, tri-, metabromsalan and
tetrachlorosalicylanilide). These are prohibited in cosmetic products because
they may cause photocontact sensitization (21 CFR 700.15).
- Methylene chloride. The use of this substance in cosmetic products is
prohibited because of its animal carcinogenicity and likely hazard to human
health (21 CFR 700.19).
- Vinyl chloride. The use of vinyl chloride is prohibited as an ingredient of aerosol
products, because of its carcinogenicity [21 CFR 700.14].
- Zirconium-containing complexes. The use of zirconium-containing complexes
in aerosol cosmetic products is prohibited because of their toxic effect on lungs,
including the formation of granulomas [21 CFR 700.16].
- Prohibited cattle materials. To protect against bovine spongiform encephalopathy
(BSE), also known as "mad cow disease," cosmetics may not be manufactured from, processed
with, or otherwise contain, prohibited cattle materials. These materials include specified
risk materials*, material from nonambulatory
cattle, material from cattle not inspected and passed, or mechanically separated beef. Prohibited
cattle materials do not include tallow that contains no more than 0.15 percent insoluble impurities,
tallow derivatives, and hides and hide-derived products, and milk and milk
products.** [21 CFR 700.27, as amended].
What cosmetic ingredients are restricted by regulation?
Some ingredients may be used in cosmetics, but only under the restrictions stated in
- Hexachlorophene. Because of its toxic effect and ability to penetrate human
skin, hexachlorophene (HCP) may be used only when an alternative preservative
has not been shown to be as effective. The HCP concentration of the cosmetic
may not exceed 0.1 percent. HCP may not be used in cosmetics that in normal
use may be applied to mucous membranes, such as the lips [21 CFR 250.250].
- Mercury compounds. Mercury compounds are readily absorbed through the
skin on topical application and tend to accumulate in the body. They may cause
allergic reactions, skin irritation, or neurotoxic manifestations. The use of
mercury compounds as cosmetic ingredients is limited to eye area cosmetics at
concentrations not exceeding 65 parts per million (0.0065 percent) of mercury
calculated as the metal (about 100 ppm or 0.01 percent phenylmercuric acetate
or nitrate) and is permitted only if no other effective and safe preservative is
available for use. All other cosmetics containing mercury are adulterated and
subject to regulatory action unless it occurs in a trace amount of less than 1 part
per million (0.0001 percent) calculated as the metal and its presence is
unavoidable under conditions of good manufacturing practice [21 CFR 700.13].
- Sunscreens in cosmetics. Use of the term "sunscreen" or similar sun
protection terminology in a product's labeling generally causes the product to be
subject to regulation as a drug.
However, sunscreen ingredients may also be used in some products for nontherapeutic,
nonphysiologic uses (for example, as a color additive or to protect the color of
the product). To avoid consumer misunderstanding, if a cosmetic product contains
a sunscreen ingredient and uses the term "sunscreen" or similar sun protection
terminology anywhere in its labeling, the term must be qualified, in accordance with
21 CFR 700.35(b), by describing the benefit to the cosmetic product provided by the
sunscreen ingredient (for example, "Contains a sunscreen to protect product
color."). Otherwise, the product may be subject to regulation as a drug
[21 CFR 700.35]. For further information on sunscreens, refer to
Information About Suntan Products, Sunscreens, and Tanning.
Are these the only ingredients that can cause a product to become violative?
No. A product may become adulterated or misbranded in a number of ways. Among
these are improperly used color additives or any ingredient,
other than a coal-tar hair dye, that causes a cosmetic to be harmful under customary or
usual conditions of use, or cause a cosmetic to become misbranded, as stated in the Federal
Food, Drug, and Cosmetic Act, Sections 601 and 602. Additionally, an ingredient having a
history of use in or as a cosmetic may at any time have its safety brought into question
by new information.
For related information, see Key Legal Concepts: Interstate Commerce,
Adulteration, and Misbranding and FDA Authority Over Cosmetics.
* "Specified risk material" means the
brain, skull, eyes, trigeminal ganglia, spinal cord, vertebral column
(excluding the vertebrae of the tail, the transverse processes of the thoracic
and lumbar vertebrae, and the wings of the sacrum), and dorsal root ganglia
of cattle 30 months and older and the tonsils and distal ileum of the
small intestine of all cattle.
** Tallow must be produced from
tissues that are not prohibited cattle materials or must contain not more
than 0.15 percent insoluble impurities as determined by the method entitled
"Insoluble Impurities" (AOCS Official Method Ca 3a-46), American Oil Chemists'
Society (AOCS), 5th Edition, 1997, incorporated by reference in accordance with
5 U.S.C. 552(a) and 1 CFR part 51, or another method equivalent in accuracy,
precision, and sensitivity to AOCS Official Method Ca 3a-46. You may obtain
copies of the method from AOCS, 2211 W. Bradley Ave.
Champaign, IL 61821.