FDA Cosmetics Handbook
This page handbook contains valuable information on FDA's requirements and
policies for safe production and accurate labeling of cosmetics. The material
in it has been carefully selected for use in the production and distribution of
The handbook is composed of five sections:
- Regulatory Requirements for Marketing Cosmetics in the United States
- Cosmetic Good Manufacturing Practice Guidelines - Cosmetic
Establishments Self-Inspection Guidelines as Excerpted from FDA's Inspection
- Cosmetic Product-Related Regulatory Requirements and Health Hazard
Issues as Excerpted from FDA's Inspection Operations Manual
- Permanently & Provisionally Listed Color Additives
- How to Obtain FDA Cosmetic Regulations
Regulatory Requirements for Marketing Cosmetics in the United States
Cosmetics marketed in the United States, whether manufactured here or
imported from abroad, must be in compliance with the provisions of the Federal
Food, Drug, and Cosmetic Act (FD&C Act), the Fair Packaging and Labeling Act
(FPLA), and the regulations published under the authority of these laws.
The regulations published by the Food and Drug Administration (FDA) are all
codified in Title 21, Code of Federal Regulations (21 CFR). The regulations
applicable to cosmetics are stated at 21 CFR, parts 700 to 740 (21 CFR 700 to
740). The color additive regulations applicable to cosmetics are found at 21 CFR
73, 74 and 82. Copies of the 21 CFR volumes containing these regulations may be
obtained at current cost from the Superintendent of Documents, U.S. Government
Printing Office, Washington, DC 20402, telephone (202) 783-3238.
The FD&C Act defines cosmetics as articles intended to be applied to the
human body for cleansing, beautifying, promoting attractiveness, or altering the
appearance without affecting the body's structure or functions. Included in this
definition are products such as skin creams, lotions, perfumes, lipsticks,
fingernail polishes, eye and facial make-up preparations, shampoos, permanent
waves, hair colors, toothpastes, deodorants, and any material intended for use
as a component of a cosmetic product. Soap products consisting primarily of an
alkali salt of fatty acid and making no label claim other than cleansing of the
human body are not considered cosmetics under the law.
Cosmetics that are also Drugs
Products that are cosmetics but are also intended to treat or prevent
disease, or otherwise affect the structure or functions of the human body, are
considered also drugs and must comply with both the drug and cosmetic provisions
of the law. Examples of products which are drugs as well as cosmetics are
anticaries toothpastes (e.g., "fluoride" toothpastes), hormone creams,
suntanning preparations intended to protect against sunburn, antiperspirants
that are also deodorants, and antidandruff shampoos.
Most currently marketed cosmetics which are also drugs are over-the-counter
drugs. Several are new drugs for which safety and effectiveness had to be proved
to the agency before they could be marketed. A new drug is a drug which is not
generally recognized by experts as safe and effective under the conditions of
intended use or which has become so recognized but has not been used to a
material extent or for a material time under such conditions.
The regulatory requirements for drugs are more extensive than the
requirements applicable to cosmetics. For example, the FD&C Act requires
that drug manufacturers register every year with the FDA and update their lists
of all manufactured drugs twice annually. See 21 CFR 207. Additionally, drugs
must be manufactured in accordance with current good manufacturing practice
regulations as codified at 21 CFR 210 and 211.
Adulterated or Misbranded Cosmetics
The FD&C Act prohibits the distribution of cosmetics which are
adulterated or misbranded. A cosmetic is considered adulterated if it contains a
substance which may make the product harmful to consumers under customary
conditions of use; if it contains a filthy, putrid, or decomposed substance; if
its container is composed of a harmful substance; if it is manufactured or held
under insanitary conditions whereby it may have become contaminated with filth,
or may have become harmful to consumers; or if it is not a hair dye that
contains a non-permitted color additive.
Coal-tar hair dyes bearing on the label the caution statement prescribed by
law and give "patch-test" instructions are exempted from the
adulteration provision even if they are irritating to the skin or are otherwise
harmful to the human body. Eyelash and eyebrow dyes are not included in this
exemption. All dyes used in eyelash and eyebrow dye products must be approved by
the FDA for such use.
A cosmetic is misbranded if its labeling is false or misleading, if it does
not bear the required labeling information, or if the container is made or
filled in a deceptive manner.
Although the FD&C Act does not require that cosmetic manufacturers or
marketers test their products for safety, the FDA strongly urges cosmetic
manufacturers to conduct whatever toxicological or other tests are appropriate
to substantiate the safety of their cosmetics. If the safety of a cosmetic is
not adequately substantiated, the product may be considered misbranded and may
be subject to regulatory action unless the label bears the following statement:
"Warning - The safety of this product has not been determined." See 21
With the exception of color additives and a few prohibited ingredients, a
cosmetic manufacturer may, on his own responsibility, use essentially any raw
material as a cosmetic ingredient and market the product without approval. The
law requires that color additives used in food, drugs and cosmetics must be
tested for safety and approved by the FDA for their intended uses. A cosmetic
containing an unlisted color additive; i.e., a color additive which has not been
approved by the FDA for its intended use, is considered adulterated and subject
to regulatory action. The color additives approved for use in cosmetics are
listed at 21 CFR 73, 74 and 82.
The use of the following ingredients is either restricted or prohibited in
cosmetics: bithionol, mercury compounds, vinyl chloride, halogenated
salicylanilides, zirconium complexes in aerosol cosmetics, chloroform, methylene
chloride, chlorofluorocarbon propellants, and hexachlorophene. See 21 CFR 700.11
to 700.23 and 250.250. The agency also considers as adulterated cosmetic nail
products containing methyl methacrylate monomer or those containing more than 5%
formaldehyde. Although not prohibited by law or regulation, in addition, the
manufacturers of cosmetic fragrance products have voluntarily agreed to not use
or to limit maximum use levels of certain selected ingredients which have been
found to cause depigmentation, irritant, neurotoxic, or phototoxic or other
Although the FD&C Act does not require cosmetic firms to register
manufacturing establishments or formulations with the FDA or make available
safety data or other information before a product is marketed in the United
States, manufacturers or distributors of cosmetics may submit this information
to the agency voluntarily. Voluntary registration and assignment of a
registration number by the agency does not denote approval of a firm or product
by the FDA. Any use of a registration number in labeling must be accompanied by
a conspicuous disclaimer phrase as prescribed by regulation. See 21 CFR 710, 720
The cosmetics distributed in the United States must comply with the labeling
regulations published by the FDA under the authority of the FD&C Act and the
FPLA. Labeling means all labels and other written, printed or graphic matter on
or accompanying a product. The label statements required under the authority of
the FD&C Act must appear on the inside as well as any outside container or
wrapper. FPLA requirements, e.g., ingredient labeling and statement of the net
quantity of contents on the principal display panel, only apply to the label of
the outer container. The labeling requirements are codified at 21 CFR 701 and
740. Cosmetics bearing false or misleading label statements or otherwise not
labeled in accordance with the codified requirements may be considered
misbranded and may be subject to regulatory action.
The principal display panel, i.e., the part of the label most likely
displayed or examined under customary conditions of display for sale (21 CFR
701.10) and generally bearing the name of the product. It must identify by
descriptive name or illustration the nature or use of the product and bear an
accurate statement of the net quantity of contents of the cosmetic in the
package in terms of weight, measure, numerical count, or a combination of
numerical count and weight or measure. The declaration must be distinct, placed
in the bottom area of the panel in line generally parallel to the base on which
the package rests, and in a type size commensurate with the size of the
container as prescribed by regulation.
The net quantity of contents statement of a solid, semi-solid or viscous
cosmetic must be in terms of the avoirdupois pound and ounce, and a statement of
liquid measure must be in terms of the U.S. gallon of 231 cubic inches and the
quart, pint, and fluid ounce subdivisions thereof. If the net quantity of
contents exceeds one pound or one pint, it must be expressed in ounces, followed
in parenthesis ( ) by a declaration of the largest whole units (i.e., pounds and
ounces or quarts and pints and ounces). The net quantity of contents may
additionally be stated in terms of the metric system of weights or measures.
The name and place of business of the firm marketing the product must be
stated on an information panel of the label (21 CFR 701.12). The address must
state the street address, city, state, and zip code. If a firm is listed in a
current city or telephone directory, the street address may be omitted. If the
distributor is not the manufacturer or packer, this fact must be stated on the
label by the qualifying phrase "Manufactured for ..." or "Distributed
by ..." or similar, appropriate wording.
The Tariff Act of 1930 (19 U.S.C. 1304) requires that all imported articles
state on the label the English name of the country of origin. See also 19 CFR
All label statements required by regulation must be in the English language
and must be placed on the label or labeling with such prominence and
conspicuousness that they are readily noticed and understood by consumers under
customary conditions of purchase (21 CFR 701.2).
Declaration of Ingredients
Cosmetics produced or distributed for retail sale to consumers for their
personal care are required to bear an ingredient declaration (21 CFR 701.3).
Cosmetics not customarily distributed for retail sale, e.g., hair preparations
or makeup products used by professionals on customers at their establishments or
skin cleansers made available to persons at their place of work, are exempt from
this requirement provided these products are not also sold to consumers at
professional establishments or workplaces for their consumption at home.
The ingredient declaration must be conspicuous so that it is likely to be
read at the time of purchase. It may appear on any information panel of the
outer container, i.e., an information panel of the folding carton, box or
wrapping if the immediate container is so pack-aged or, if not packaged in an
outer container, an information panel of the jar, tube or bottle containing the
product. The ingredient declaration may also appear on a tag, tape or card that
is firmly affixed to the outer container. The letters must not be less than 1/16
of an inch in height (21 CFR 701.3(b)). If the total package surface available
to bear labeling is less than 12 square inches, the letters must not be less
than 1/32 of an inch in height (21 CFR 701.3(p)). Off-package ingredient
labeling is permitted if the cosmetic is held in tightly compartmented trays or
racks, it is not enclosed in a folding carton, and the package surface area is
less than 12 square inches (21 CFR 701.3(i)).
The ingredients must be declared in descending order of predominance. Color
additives (21 CFR 701.3(f)(3)) and ingredients present at one percent or less
(21 CFR 701.3(f)(2)) may be declared after the ingredients present at
concentrations exceeding one percent without regard for predominance. The
ingredients must be identified by the names established or adopted by regulation
(21 CFR 701.3(c)); those accepted by the FDA as exempt from public disclosure
may be stated as "and other ingredients" (21 CFR 701.3(a)).
Cosmetics which are also drugs must first identify the drug ingredient(s) as
"active ingredients(s)" before listing the cosmetic ingredients (21
Cosmetics which may be hazardous to consumers when misused must bear
appropriate label warnings and adequate directions for safe use. The statements
must be prominent and conspicuous. Some cosmetics must bear label warnings or
cautions prescribed by regulation (21 CFR 740). Cosmetics in self-pressurized
containers (aerosol products), feminine deodorant sprays and, children's bubble
bath products are examples of products requiring such statements.
Liquid oral hygiene products (e.g., mouthwashes, fresheners) and all
cosmetic vaginal products (e.g., douches, tablets) must be packaged in
tamper-resistant packages when sold at retail. A package is considered
tamper-resistant if it has an indicator or barrier to entry (e.g., shrink or
tape seal, sealed carton, tube or pouch, aerosol container) which, if breached
or missing, alerts a consumer that tampering has occurred. The indicator must be
distinctive by design (breakable cap, blister) or appearance (logo, vignette,
other illustration) to preclude substitution. The tamper-resistant feature may
involve the immediate or outer container or both. The package must also bear a
prominently placed statement alerting the consumer to the tamper-resistant
feature. This statement must remain unaffected if the tamper-resistant feature
is breached or missing. See 21 CFR 700.25.
Law Enforcement Authority
For enforcement of the law, the FDA may conduct examinations and
investigations of products, inspect establishments in which products are
manufactured or held, and seize adulterated (harmful) or misbranded (incorrectly
or deceptively labeled or filled) cosmetics. Adulterated or misbranded foreign
products may be refused entry into the United States. To pre-vent further
shipment of an adulterated or misbranded product, the agency may request a
federal district court to issue a restraining order against the manufacturer or
distributor of the violative cosmetic. The FDA may also initiate criminal action
against a per-son violating the law. Examples of products seized are nail
preparations containing methyl methacrylate or formaldehyde, various eyebrow and
eyelash dye products containing prohibited coal-tar dyes, and products
contaminated with harmful microorganisms.
Further questions regarding regulatory requirements for marketing cosmetics
should be directed to the Food and Drug Administration, Division of Colors and
Cosmetics (HFF-440), 200 C Street, SW, Washington, DC 20204. Questions regarding
requirements for marketing products which are cosmetic and drugs should also be
addressed to the Division of Drug Labeling, OTC Compliance Branch (HFN-312),
5600 Fishers Lane, Rockville, MD 208567.
Cosmetic Good Manufacturing Practice Guidelines
The Federal Food, Drug, and Cosmetic Act prohibits the introduction or
delivery for introduction into interstate commerce of cosmetics that are
adulterated or misbranded (Sec. 301).
A cosmetic may be deemed adulterated (Sec. 601) for essentially four
- It may be injurious to users under conditions of customary use because it
contains, or its container is composed of, a potentially harmful substance.
- It contains filth.
- It contains a non-permitted, or in some instance non-certified, color
- It is manufactured or held under insanitary conditions whereby it may have
become injurious to users or contaminated with filth.
A cosmetic may be deemed misbranded (Sec. 602) for reasons of:
- False or misleading labeling.
- Failure to state prominently and conspicuously any information required by
or under authority of this act.
- Misleading container presentation or fill.
To determine whether cosmetic firms manufacture, hold or deliver for
introduction into interstate commerce cosmetics that are adulterated or
misbranded, and to prevent these and other practices violating Sec. 301 of the
FD&C Act, the law gives the agency the authority to enter the establishments
of such firms and inspect their facilities as well as all pertinent equipment,
finished and unfinished materials, containers and labeling therein. See Sec.
704(a) of the FD&C Act.
Rigorous adherence to good manufacturing practice minimizes the risk of
adulteration or misbranding of cosmetics. The following cosmetic establishment
instructions, excerpted from FDA's Inspection Operations Manual, may serve as
guidelines for effective self-inspection. A good inspection score means that an
establishment follows good manufacturing practice.
1. Building and Facilities. Check whether:
a. Buildings used in the manufacture or storage of cosmetics are of suitable
size, design and construction to permit unobstructed placement of equipment,
orderly storage of materials, sanitary operation, and proper cleaning and
b. Floors, walls and ceilings are constructed of smooth, easily cleanable
surfaces and are kept clean and in good repair.
c. Fixtures, ducts and pipes are installed in such a manner that drip or
condensate does not contaminate cosmetic materials, utensils, cosmetic contact
surfaces of equipment, or finished products in bulk.
d. Lighting and ventilation are sufficient for the intended operation and
comfort of personnel.
e. Water supply, washing and toilet facilities, floor drainage and sewage
system are adequate for sanitary operation and cleaning of facilities, equipment
and utensils, as well as to satisfy employee needs and facilitate personal
2. Equipment. Check whether:
a. Equipment and utensils used in processing, holding, transferring and
filling are of appropriate design, material and workmanship to prevent
corrosion, buildup of material, or adulteration with lubricants, dirt or
b. Utensils, transfer piping and cosmetic contact surfaces of equipment are
well-maintained and clean and are sanitized at appropriate intervals.
c. Cleaned and sanitized portable equipment and utensils are stored and
located, and cosmetic contact surfaces of equipment are covered, in a manner
that protects them from splash, dust or other contamination.
3. Personnel. Check whether:
a. The personnel supervising or performing the manufacture or control of
cosmetics has the education, training and/or experience to perform the assigned
b. Persons coming into direct contact with cosmetic materials, finished
products in bulk or cosmetic contact surfaces, to the extent necessary to
prevent adulteration of cosmetic products, wear appropriate outer garments,
gloves, hair restraints etc., and maintain adequate personal cleanliness.
c. Consumption of food or drink, or use of tobacco is restricted to
appropriately designated areas.
4. Raw Materials. Check whether:
a. Raw materials and primary packaging materials are stored and handled in a
manner which prevents their mix-up, contamination with microorganisms or other
chemicals, or decomposition from exposure to excessive heat, cold, sunlight or
b. Containers of materials are closed, and bagged or boxed materials are
stored off the floor.
c. Containers of materials are labeled with respect to identity, lot
identification and control status.
d. Materials are sampled and tested or examined in conformance with
procedures assuring the absence of contamination with filth, microorganisms or
other extraneous substances to the extent necessary to prevent adulteration of
finished products. Pay particular attention to materials of animal or vegetable
origin and those used in the manufacture of cosmetics by cold processing methods
with respect to contamination with filth or microorganisms.
e. Materials not meeting acceptance specifications are properly identified
and controlled to prevent their use in cosmetics.
5. Production. Check whether manufacturing and control have been established
and written instructions, i.e., formulations, processing, transfer and filling
instructions, in-process control methods etc., are being maintained. Determine
whether such procedures require that:
a. The equipment for processing, transfer and filling the utensils, and the
containers for holding raw and bulk materials are clean, in good repair and in
b. Only approved materials are used.
c. Samples are taken, as appropriate, during and/or after processing,
transfer or filling for testing for adequacy of mixing or other forms of
processing, absence of hazardous microorganisms or chemical contaminants, and
compliance with any other acceptance specification.
d. Weighing and measuring of raw materials is checked by a second person,
and containers holding the materials are properly identified.
e. Major equipment, transfer lines, containers and tanks used for
processing, filling or holding cosmetics are identified to indicate contents,
batch designation, control status and other pertinent information.
f. Labels are examined for identity before labeling operations to avoid
g. The equipment for processing, holding, transferring and filling of batch
is labeled regarding identity, batch identification and control status.
h. Packages of finished products bear permanent code marks.
i. Returned cosmetics are examined for deterioration or contamination.
6. Laboratory Controls. Check whether:
a. Raw materials, in-process samples and finished products are tested or
examined to verify their identity and determine their compliance with
specifications for physical and chemical properties, microbial contamination,
and hazardous or other unwanted chemical contaminants.
b. Reserve samples of approved lots or batches of raw materials and finished
products are retained for the specified time period, are stored under conditions
that protect them from contamination or deterioration, and are retested for
continued compliance with established acceptance specifications.
c. The water supply, particularly the water used as a cosmetic ingredient,
is tested regularly for conformance with chemical-analytical and microbiological
d. Fresh as well as retained samples of finished products are tested for
adequacy of preservation against microbial contamination which may occur under
reasonably foreseeable conditions of storage and consumer use.
7. Records. Check whether control records are maintained of:
a. Raw materials and primary packaging materials, documenting disposition of
b. Manufacturing of batches, documenting the:
(i) Kinds, lots and quantities of materials used.
(ii) Processing, handling, transferring, holding and filling.
(iii) Sampling, controlling, adjusting and reworking.
(iv) Code marks of batches and finished products.
c. Finished products, documenting sampling, individual laboratory controls,
test results and control status.
d. Distribution, documenting initial interstate shipment, code marks and
8. Labeling. Check whether the labels of the immediate and outer containers
a. On the principal display panel:
(i) In addition to the name of the product, the statements of identity and
(ii) The statement "Warning - The safety of this product has not been
determined" if the safety of the respective product has not adequately been
substantiated. Determine whether and what toxicological and/or other testing the
firm has conducted to substantiate the safety of its products. See 21 CFR
b. On an information panel:
(i) The name and address of the firm manufacturing the product or
introducing it into interstate commerce.
(ii) The list of ingredients (only on outer container) if intended for sale
or customarily sold to consumers for consumption at home.
(iii) The warning statement(s) required at 21 CFR 740.11, 740.12 and 740.17.
(iv) Any other warning statement necessary or appropriate to prevent a
health hazard. Determine the health hazard or other basis for a warning
(v) Any direction for safe use of product.
(vi) In the case of a hair dye product, the caution statement of sec. 601(a)
of the Act and appropriate directions for preliminary patch testing. This
warning only applies to coal-tar hair dyes which, if so labeled, are then
exempted from the adulteration provision of the Act.
9. Complaints. Check whether the firm maintains a consumer complaint file
a. The kind and severity of each reported injury and the body part involved.
b. The product associated with each injury, including the manufacturer and
c. The medical treatment involved, if any, including the name of the
d. The name(s) and location(s) of any poison control center, government
agency, physician's group etc., to whom formula information and/or toxicity data
e. Whether the firm voluntarily files Cosmetic Product Experience Reports
(21 CFR 730).
10. Other. Check whether the firm is:
a. Participating in the program of voluntary registration of:
(i) Cosmetic manufacturing establishments (21 CFR 710).
(ii) Cosmetic product ingredient and cosmetic raw material composition
statements (21 CFR 720).
(iii) Cosmetic product experiences (21 CFR 730).
b. Using a color additive which is not listed for use in cosmetics (21 CFR
73, 74 and 82) or which is not certified (21 CFR 80).
c. Using a prohibited cosmetic ingredient (21 CFR 700).
Cosmetic Product-Related Regulatory Requirements and Health Hazard
Cosmetics produced or distributed for retail sale to consumers for their
personal care are required to bear an ingredient declaration (21 CFR 701.3).
Cosmetics not customarily distributed for retail sale, e.g., hair preparations
or make-up products used by professionals at their establishments and skin
cleansing or emollient creams used at places of work, are exempt from this
requirement provided these products are not also sold to consumers.
The ingredient declaration must be conspicuous so that it is likely to be
read at the time of purchase. It may appear on any information panel of the
package, i.e., the folding carton, box or wrapping if the immediate container is
so packaged, and may also appear on a firmly affixed tag, tape or card. The
letters must not be less than 1/16 of an inch in height (701.3(b)). If the total
package surface available to bear labeling is less than 12 square inches, the
letters must not be less than 1/32 of an inch in height (701.3(p)). Off-package
ingredient labeling is permitted if the cosmetic is held in tightly
compartmented trays or racks, it is not enclosed in a folding carton, and the
package surface area is less than 12 square inches (701.3(i)).
The ingredients must be declared in descending order of predominance. Color
additives (701.3(f)(3)) and ingredients present at one percent or less
(701.3(f)(2)) may be declared without regard for predominance. The ingredients
must be identified by the names established or adopted by regulation (701.3(c));
those accepted by the FDA as exempt from public disclosure may be stated as "and
other ingredients" (701.3(a)).
Cosmetics which are also drugs must first identify the drug ingredient(s) as
"active ingredient(s)" before listing the cosmetic ingredients
Prohibited Ingredients and other Hazardous Substances
1. Hexachlorophene (21 CFR 250.250).
Because of its neurotoxic 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%, and it may not be used in cosmetics which in normal use may be
applied to mucous membrane.
2. Mercury compounds (21 CFR 700.13).
The use of mercury compounds as cosmetic ingredients is limited to eye area
cosmetics at concentrations not exceeding 65 parts per million (0.0065%) of
mercury calculated as the metal (about 100 ppm or 0.01% phenylmercuric acetate
or nitrate) and provided no other effective and safe preservative is available
Mercury compounds are readily absorbed through the skin on topical
application and have the tendency to accumulate in the body. They may cause
allergic reactions, skin irritation or neurotoxic manifestations.
3. Chlorofluorocarbon propellants (21 CFR 700.23 and 2.125).
The use of chlorofluorocarbon propellants (fully halogenated
chlorofluoroalkanes) in cosmetic aerosol products intended for domestic
consumption is prohibited.
Chlorofluorocarbon-containing cosmetic aerosol products may continue to be
manufactured for export provided they are not in conflict with the laws of the
country to which they are to be exported and the following control system is
being followed to ensure that there is no likelihood, by mistake or otherwise,
of diversion of such products into domestic commerce:
(a) The manufacturer has an order from the foreign purchaser stating the
exact amount desired, that a chlorofluorocarbon be used as propellant, and that
he is aware of its illegality in the United States. The manufacturer must also
have in his possession a current letter from a responsible official of the
country to which the product is to be shipped stating that the use of
chlorofluorocarbon propellants is legal in the respective country.
(b) The stock of chlorofluorocarbon propellants intended for export
production is kept under adequate security at all times.
(c) During all stages of manufacture and storage the
chlorofluorocarbon-containing aerosol product is kept segregated from all other
products and is clearly marked "for export only."
(d) Complete records are kept accounting for all chlorofluorocarbon
propellant use as well as for all manufacture, storage, shipment and exportation
of aerosol products containing these propellants. These records must be
retained for at least 3 years and made available to any FDA official upon oral
or written request.
4. Other prohibited ingredients.
The following additional substances are prohibited as cosmetic ingredients,
(but not as unintentional contaminants of cosmetics manufactured in accordance
with current good manufacturing practices):
(a) Bithionol because of its likelihood of causing photo-contact
sensitization (21 CFR 700.11).
(b) Halogenated salicylanilides (di-, tri-, metabromsalan and
tetrachlorosalicylanilide) because of their potential of causing photocontact
sensitization (21 CFR 700.15).
(c) Chloroform because of its animal carcinogenicity and likely hazard to
human health (21 CFR 700.18).
(d) Vinyl chloride as an ingredient of aerosol products because of its
carcinogenic effect in humans and animals (21 CFR 700.14).
(e) Zirconium-containing complexes in aerosol cosmetic products because of
their toxic effect on lungs, including granulomas (21 CFR 700.16).
(f) Methylene chloride because of its animal carcinogenicity and likely
hazard to human health (21 CFR 700.18).
5. Acetylethyltetramethyltetralin (AETT).
AETT should not be used in fragrance formulations and finished cosmetic
products (usually in products claiming to be fragrance-free). In a subchronic
toxicity study in rats conducted in 1977, AETT was found to cause serious
neurotoxic disorders and discoloration of internal organs. It was also
determined to penetrate human skin. The fragrance industry voluntarily
discontinued use of AETT in 1978.
6. Musk ambrette.
Various tests and clinical experience have demonstrated that musk ambrette
may cause photocontact sensitization, i.e., allergic reactions of the skin on
exposure to musk ambrette and sunlight. Other studies have indicated that musk
ambrette may also cause neurotoxic effects. The International Fragrance
Association has recommended that musk ambrette should not be used in products
applied to the skin, particularly those products used on skin that is
customarily also exposed to sunlight.
7. 6-Methylcoumarin (6-MC).
The fragrance ingredient 6-MC is a potent photo-contact sensitizer which may
cause serious skin and systemic disorders in some consumers on contact in the
presence of sunlight. Between 1976 and 1978, the FDA received many reports of
adverse reactions associated with the use of 6-MC-containing suntan
preparations. The photocontact allergenicity of 6-MC was subsequently confirmed
in clinical studies. In 1978, the FDA asked the manufacturers of suntan and
sunscreen products to discontinue the use of 6-MC. Two firms voluntarily
recalled products containing 6-MC from the market.
Cosmetics containing as ingredients amines or amino derivatives,
particularly di- or triethanolamine, may form nitrosamines if they also contain
an ingredient which acts as a nitrosating agent as, for example,
2-bromo-2-nitropropane-1,3-diol (Bronopol, Onyx-ide 500),
5-bromo-5-nitro-1,3-dioxane (Bronidox C) or tris (hydroxymethyl) nitromethane
(Tris Nitro), or if they are contaminated with a nitrosating agent, e.g., sodium
nitrite. Amines and their derivatives are mostly present in creams, cream
lotions, hair shampoos and cream hair conditioners. The nitrosation may occur
during manufacture or during product storage.
Many nitrosamines have been determined to cause cancer in laboratory
animals. They have also been shown to penetrate the skin. Nitrosamine
contamination of cosmetics became an issue in early 1977. In a study of 29
cosmetic creams and lotions, N-Nitrosodiethanolamine (NDELA) was determined in
27. The levels of NDELA contamination ranged from less than 10 parts per billion
(ppb) to 50 parts per million (ppm). Of the more than 300 cosmetic samples
analyzed in 1978, 1979 and early 1980 in FDA's laboratories, 7% contained less
than 30 ppb NDELA, 26% contained 30 ppb to 2 ppm and 7% contained between 2 ppm
and 150 ppm.
The FDA expressed its concern about the contamination of cosmetics with
nitrosamines in a notice published in the Federal Register of April 10, 1979 (44
FR 21365). It stated that cosmetics containing nitrosamines may be considered
adulterated and subject to enforcement action. In surveys of cosmetic products
conducted in 1991-92, NDELA was found in 65% of the samples at levels up to 3
Cosmetics containing as ingredients ethoxylated surface active agents, i.e.,
detergents, foaming agents, emulsifiers and certain solvents identifiable by the
prefix, word or syllable "PEG," "Polyethylene," "Polyethylene
glycol," "Polyoxyethylene," "-eth-," or "-oxynol-,"
may be contaminated with 1,4-dioxane. It may be removed from ethoxylated
compounds by means of vacuum stripping at the end of the polymerization process
without an unreasonable increase in raw material cost.
In rodent feeding studies conducted for the National Cancer Institute,
1,4-dioxane was found to produce cancer of the liver and the nasal turbinates.
It also caused systemic cancer in a skin painting study. Skin absorption studies
demonstrated that dioxane readily penetrates animal and human skin from various
types of vehicles. However, it was also determined that most of the dioxane
applied to the skin in a vehicle evaporates into the environment and may not be
available for skin absorption.
The contamination of ethoxylated surface-active agents with dioxane was
first reported in 1978. Many of the raw materials analyzed since then have been
found to contain dioxane; some contained as much as, or more than, 100 ppm. In
finished cosmetic products containing ethoxylated surface-active agents, the
incidence and level of dioxane contamination was significantly lower.
Adequacy of Preservation
Cosmetics need not be sterile, however, they must not be contaminated with
microorganisms which may be pathogenic, and the density of non-pathogenic
microorganisms should be low. In addition, cosmetics should remain in this
condition when used by consumers. Some cosmetics, i.e., those containing more
than about 10% ethanol, propylene glycol, glycerol, etc., and cosmetics in
self-pressurized containers, are usually self-preserving and are not likely to
become contaminated with microorganisms.
The hazard of inadequately preserved cosmetics to human health has been
amply demonstrated by reports of staphylococcal infections in hospitals from use
of contaminated hand creams and hand lotions and in studies conducted on eye
area cosmetics. Regardless of whether a cosmetic becomes contaminated during
manufacture or during consumer use, the hazard is twofold, namely, (1) the
direct effect of microorganisms on human health and (2) the circuitous effect on
human health due to product contamination and spoilage, product separation, or
formation of harmful microbial metabolites.
Microbial contamination of cosmetics during manufacture was a major issue
during the 1960's and early 1970's. Since then, significant progress has been
made by the cosmetic industry towards implementation of sanitary manufacturing
practices, more rigorous microbiological control, and the development of
better-preserved cosmetic products. However, the problem of adequacy of
preservation of cosmetics to prevent contamination during consumer use continues
to be of concern to the agency, particularly with respect to cosmetics coming
into contact with the eye.
The studies conducted to determine the hazard associated with inadequately
preserved eye area cosmetics revealed that microbial contamination of new
mascaras was rare but that many became readily contaminated with the
microorganisms found on the eyelids and fingers of consumers. If an inadequately
preserved mascara becomes contaminated with Pseudomonas aeruginosa and the
delicate cornea of the eye is scratched with the applicator, the eye may become
infected. P. aeruginosa is an ubiquitous microorganism which may also
occasionally be present on the skin. Corneal ulceration may lead to partial or
total blindness in the injured eye. Several cases of corneal ulceration and
blindness associated with Pseudomonas-contaminated mascaras have been
identified. Eye area cosmetics contaminated with Staphylococcus epidermidis or
other cocci may cause conjunctivitis or blepharitis.
The issue of adequacy of preservation of eye area cosmetics was addressed in
the Federal Register notice of October 11, 1977 (42 FR 54837). The agency
announced its intention to propose regulations and invited interested persons to
submit information on microbial testing methods and standards of performance
suitable to ensure that such cosmetics do not become contaminated with
microorganisms during manufacture and use by consumers. Since no useful
information was received about such methods, the agency decided to have
standards for determining adequacy of preservation developed under contract, and
this work is currently underway. The notice also stated that "FDA does not
intend to await the completion of the rulemaking pronounced in this notice of
intent before taking needed regulatory action."
In addition to sanitary storage and handling of raw materials and sanitary
manufacture of finished products, it is recommended that:
(a) Each batch of a cosmetic which is not self-preserving be tested for
microbial contamination before it is released for interstate shipment, and
(b) Each cosmetic, particularly each eye area cosmetic, be tested during
product development for adequacy of preservation against microbial contamination
which may occur under reasonably foreseeable conditions of consumer use.
Chlorofluorocarbon propellants, vinyl chloride, and zirconium compounds are
prohibited as ingredients of cosmetic aerosol products (21 CFR 700.23, 700.14
Cosmetic aerosol products must bear the following label statement (21 CFR
Warning - Avoid spraying in eyes. Contents under pressure. Do not puncture
or incinerate. Do not store at temperature above
120 degrees F. Keep out of reach of children.
Hydrocarbon propellant-containing products must also bear the statement (21
Warning - Use only as directed. Intentional misuse by deliberately
concentrating and inhaling the contents can be harmful or fatal.
Exempt from the second warning requirement are:
(a) Foam or cream products containing less than 10% propellant.
(b) Products in a container with a physical barrier that prevents escape of
the propellant at the time of use.
(c) Products with a net quantity of contents of less than 2 ounces and
equipped with a metering valve.
(d) Products with a net quantity of contents of less than ½ ounce.
Feminine Deodorant Sprays
Products whose labeling states or suggests that the product is for use in
the female genital area or for use all over the body must bear the following
label statement (21 CFR 740.12):
Caution - For external use only. Spray at least 8 inches from skin. Do not
apply to broken, or irritated, or itching skin. Persistent, unusual odor or
discharge may indicate conditions for which a physician should be consulted.
Discontinue use immediately if rash, irritation, or discomfort develops.
Feminine deodorant sprays which are not packaged in self-pressurized
containers, need not bear the sentence "Spray at least 8 inches from skin."
If they are aerosol products, they must also bear the warning required at 21 CFR
740.11(a)(1). Additionally, if the propellant is a hydrocarbon, the label must
bear the warning required at 740.11(b)(1).
Bubble Bath Products
The risk associated with certain conditions of use of foaming detergent bath
products, i.e., bubble bath products, particularly excessive or prolonged
exposure, has been known for some time. Over the years, the agency has received
numerous complaints from consumers and physicians about itching, rashes and
urinary tract disorders. Reports in the medical literature have mentioned that
the adverse reactions either subsided or disappeared when the use of bubble bath
products was discontinued. Most adverse reactions appeared to have been caused
by inadvertent product misuse which may not have occurred if consumers had been
given proper directions for safe use of these products and had been cautioned
about the possible adverse effects by means of a mandatory label warning.
In 1980, the FDA published a regulation requiring that the labels of bubble
bath products bear adequate directions for safe use and the prescribed caution
statement. The effective date was subsequently stayed to permit reconsideration
of the regulation. The new effective date of the revised regulation (it does
not apply to foaming detergent bath products clearly labeled that they are
intended for use exclusively by adults) is June 5, 1987 (51 FR 20471).
The regulation (21 CFR 740.17) requires that children's foaming detergent
bath products, i.e., children's bubble bath products, and all foaming detergent
bath products not labeled as intended for use exclusively by adults, bear
adequate directions for safe use and this caution:
Caution - Use only as directed. Excessive use or prolonged exposure may
cause irritation to skin and urinary tract. Discontinue use if rash, redness,
or itching occur. Consult your physician if irritation persists. Keep out of
reach of children.
For the purpose of this regulation, a foaming deter-gent bath product
(bubble bath product) is defined as any product intended to be added to the bath
for the purpose of producing foam and containing a surface-active agent serving
as a detergent or foaming agent. Examples of label statements properly
identifying a product as being intended for use exclusively by adults are: "Keep
out of reach of children" or "For adult use only."
Hair Dye Products
Hair dye products may be divided into three categories, i.e., permanent,
semi-permanent and temporary hair colors. Permanent hair colors are the most
popular hair dye products. They may be further divided into oxidation hair dyes
and progressive hair dyes. Oxidation hair dye products consist of (1) a solution
of dye intermediates, e.g., p-phenylene-diamine, which form hair dyes on
chemical reaction, and preformed dyes, e.g., 2-nitro-p-phenylene-diamine, which
already are dyes and are added to achieve the intended shades, in an aqueous,
ammoniacal vehicle containing soap, detergents and conditioning agents; and, (2)
a solution of hydrogen peroxide, usually 6%, in water or a cream lotion.
The ammoniacal dye solution and the hydrogen peroxide solution, often called
the developer, are mixed shortly before application to the hair. The applied
mixture causes the hair to swell and the dye intermediates (and preformed dyes)
penetrate the hair shaft to some extent before they have fully reacted with each
other and the hydrogen peroxide and formed the hair dye.
Progressive hair dye products contain lead acetate as the active ingredient.
Lead acetate is approved as a color additive for coloring hair on the scalp at
concentrations not exceeding 0.6% w/v, calculated as metallic lead (21 CFR
73.2396). Bismuth citrate, the other approved color additive (21 CFR 73.2110),
is used to a much lesser extent. Progressive hair dyes change the color of hair
gradually from light straw color to almost black by reacting with the sulfur of
hair keratin as well as oxidizing on the hair surface.
Semi-permanent and temporary hair coloring products are solutions (on rare
occasions dry powders) of various coal-tar, i.e., synthetic organic, dyes which
deposit and adhere to the hair shaft to a greater or lesser extent. Temporary
hair colors must be re-applied after each shampooing. The vehicle may consist of
water, organic solvents, gums, surfactants and conditioning agents. The coal-tar
dyes are either listed and certified color additives or dyes for which approval
has not been sought. The dyes may not be non-permitted metallic salts or
A hair dye product containing a non-approved coal-tar color (but not a
non-approved metallic or vegetable dye) which is known to cause adverse
reactions under conditions of use cannot be considered adulterated if the label
bears the caution statement provided in section 601(a) of the FD&C Act and
offers adequate directions for preliminary patch testing by consumers for skin
sensitivity. The caution statement reads as follows:
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.
If the label of a coal-tar color-containing hair dye product does not bear
the caution statement of section 601(a) and the patch testing directions, it may
be subject to regulatory action if it is determined to be harmful under
customary conditions of use.
Several coal-tar hair dye ingredients have been found to cause cancer in
laboratory animals. In the case of 4-methoxy-m-phenylenediamine (4-MMPD,
2,4-diaminoanisole) which had also been demonstrated in human and animal studies
to penetrate the skin, the agency considered the risk associated with its use in
hair dyes a "material fact" which should be made known to consumers.
The regulation requiring a label warning on hair dye products containing 4-MMPD
published in October 1979 was to become effective April 16, 1980. The regulation
required that hair dyes containing 4-MMPD bear the following warning:
Warning - Contains an ingredient that can penetrate your skin and has been
determined to cause cancer in laboratory animals.
Some hair dye manufacturers held that the potential risk was too small to be
considered "material" and challenged the validity of the regulation in
court. The agency decided to reconsider its earlier position, entered into a
consent agreement with the hair dye manufacturers, and stayed the effectiveness
of the regulation until completion of an assessment of the carcinogenic risk of
4-MMPD in accordance with scientifically accepted procedures.
In addition to 4-MMPD, the following other hair dye ingredients have been
reported to cause cancer in at least one animal species in lifetime feeding
studies: 4-chloro-m-phenylenediamine, 2,4-toluenediamine,
2-nitro-p-phenylenediamine and 4-amino-2-nitro-phenol. They also were found to
penetrate human and animal skin.
Depilatories and Hair Straighteners
Chemical depilatories are highly alkaline pastes, creams or cream lotions
containing either alkali or alkali-earth sulfides (usually up to 35% barium or
strontium sulfide) or mixtures of alkali-earth hydroxides (usually 5-10% calcium
hydroxide) and salts of aliphatic mercapto acids (usually 2-5% calcium
thioglycolate). These ingredients cause degradation of hair keratin and
deterioration of hair fibers to a jelly-like mass that can easily be removed by
wiping or scraping. The pH of chemical depilatories usually falls between 10 and
Hair straighteners are mostly creams or cream lotions containing about 3%
sodium hydroxide or, as a kit, a lotion containing about 5% calcium hydroxide
and a solution of up to about 30% guanidine carbonate. The pH is around 12. Some
straighteners contain about 4% ammonium thioglycolate as the active ingredient.
Because improperly formulated or incorrectly used depilatories or hair
straighteners may cause serious skin irritation, they should be thoroughly
tested for safety, be subjected to careful quality control during manufacture,
and provide explicit warnings and directions for safe use.
Hair Shampoos, Rinses, Conditioners
Hair shampoos contain anionic or ampholytic detergents serving as cleansing
and foaming agents; rinses and conditioners may contain cationics (quaternary
ammonium compounds) serving as antistatic agents. When inadvertently introduced
into the eye, these surface active agents may cause stinging, mucosal irritation
or even corneal damage; and products contaminated with microorganisms may cause
If the cornea has been scratched or otherwise damaged, pathogenic
microorganisms, particularly Pseudomonas aeruginosa, may cause corneal
ulceration and blindness. Cosmetic hair products may be adequately preserved
with, for example, formaldehyde or formaldehyde releasing preservatives to
prevent microbial contamination. See section on "Adequacy Of Preservation"
Hair care products, like all other cosmetics, should be tested thoroughly to
determine the type and degree of irritation that may occur when coming into
contact with the eye and to assure that marketed products are not contaminated
and will not become contaminated during normal use. The labels of these products
should bear appropriate warnings and directions for safe use.
Products Containing Estrogenic Hormones, Placental Extract or Vitamins
Products containing estrogen, estrone, estradiol, progesterone, placental
extract or vitamins may be considered drugs, misbranded drugs, or misbranded
cosmetics, particularly if the label declaration is supplemented with standards
implying prevention or treatment of disease or effect on the structure or any
function of the human body. See Federal Register notice of the proposed rule of
October 28, 1977 (42 FR 56757) and 21 CFR 201.300.
The estrogen content of an OTC product, be it a drug or a drug as well as
cosmetic, may not exceed 10,000 IU per ounce. Users must be directed to limit
the amount of product applied daily so that no more than 20,000 IU of estrogen
or equivalent be used per month. Some estrogen-containing products have been
claiming to prevent or reduce wrinkles, treat seborrhea, or stimulate hair
growth. The Advisory Review Panel on OTC Miscellaneous External Drug Products
has concluded that there are inadequate data to establish the safety of these
products and that they are ineffective and may therefore be misbranded, even if
marketed as cosmetics without making medicinal claims. See Advance notice of
proposed rulemaking, Federal Register of January 5, 1982 (47 FR 430). It should
be noted, however, that this panel's recommendation has not yet been accepted by
the FDA as a basis for regulatory decisions.
In addition to being considered misbranded drugs, products claiming to
contain placental extract may also be deemed to be misbranded cosmetics if the
extract has been prepared from placentas from which the hormones and other
biologically active substances have been removed and the extracted substance
consists principally of protein. The FDA recommends that this substance be
identified by a name other than "placental extract" which describes
its composition more accurately because consumers associate the name "placental
extract" with a therapeutic use or some biological activity.
Cosmetics declaring ingredients as vitamins as, for example, tocopherol as
vitamin E, convey the misleading impression that these ingredients and products
offer a nutrient or health benefit and may therefore be deemed misbranded. The
second edition of the CTFA Cosmetic Ingredient Dictionary, the currently
recognized source of cosmetic ingredient names, lists "vitamin"
ingredients by their respective chemical names.
Nail Builders, Hardeners, Enamels
Nail builders (elongators, extenders) have been involved in numerous reports
of irritation, inflammation and infection of the nail bed and nail fold as well
as in complaints of discoloration, splitting and loss of fingernails. The
products are marketed as kits consisting of a powder (a mixture of methyl
methacrylate polymer and peroxide catalyst) and a liquid (a mixture of
methacrylate ester monomer and promoter). Ultraviolet light-cured products
consist of a single unit containing methacrylate ester monomers, polyurethane
and a curing agent (e.g., hydroxylcyclohexyl phenyl ketone).
The methacrylate monomers currently used in nail builders are mostly ethyl,
hydroxyethyl, butyl, iso-butyl, hydroxypropyl or other esters of methacrylic
acid. Methyl methacrylate is now rarely used because of a court ruling in an
injunction proceeding against a former manufacturer of nail builders and
numerous seizures and recalls of methyl methacrylate-containing products. The
currently used esters of methacrylic acid may be as harmful as methyl
Nail hardeners often contain formaldehyde as the active ingredient. Although
formaldehyde may be irritating to the skin or cause allergic reactions, the FDA
does not object to its use as an ingredient of nail hardeners provided the
- Contains no more than 5% formaldehyde,
- Provides the user with nail shields which restrict application to the tip
(and not the nail bed or fold),
- Furnishes adequate directions for safe use, and
- Warns consumers about the consequences of misuse and potential for causing
adverse reactions in sensitized users.
The safety of formaldehyde as a cosmetic ingredient was reviewed in 1984 by
a panel of scientific experts appointed by the Cosmetic, Toiletry and Fragrance
Association, a trade association representing a major portion of the cosmetic
industry. The panel reported that available toxicological data and other
information were insufficient to conclude that cosmetics containing formaldehyde
in excess of 0.2% are safe. (J. American Coll. Tox., 3, 3, 157-184, 1984).
Nail enamels usually consist of nitrocellulose and
arylsulfonamide-formaldehyde resin as film formers, toluene or ethyl or butyl
acetate as solvents, and phthalate, citrate or phosphate esters as plasticizers.
Adverse reactions associated with nail enamels are not uncommon. The
formaldehyde resin or residual formaldehyde may elicit allergic reactions in
already sensitized consumers, the solvents or plasticizers may be irritating,
and the deposited film may cause irritation and inflammation because of its
occlusiveness or lack of flexibility. Nail enamels marketed as hardeners have
had a particularly high rate of adverse reactions. Their high resin content or
low concentration of plasticizer causes them to be particularly occlusive and
inflexible. Another frequent complaint is flammability during and shortly after
Products that are "soap" are exempt from the provisions of the FD&C
Act because soap is excluded from the definition of the term "cosmetic"
in Section 201(i) of the Act. The FDA interprets the term "soap" to
apply to products:
- Intended for cleansing the human body,
- Labeled, sold and represented solely as soap, and,
- Consisting primarily (i.e., the bulk of its non-volatile matter serving as
the detergent) of alkali salts of fatty acids (21 CFR 701.20).
Products consisting of detergents, or products consisting primarily of
alkali salts of fatty acids and intended not only for cleansing but also for
other cosmetic uses, i.e., products intended also for beautifying, promoting
attractiveness or altering the appearance, must comply with the regulatory
requirements applicable to cosmetics and must, for example, bear ingredient
declarations as required at 21 CFR 701.3. They may also be regulated as drugs if
intended to cure, treat or prevent disease or if intended to affect the
structure or any function of the human body.
Products intended solely for cleansing of the human body and having
characteristics consumers generally associate with soap may be identified in
labeling as soap even though they do not consist predominantly of alkali salts
of fatty acids. However, these products are regulated as cosmetics.
Suntan products generally are sunscreening preparations which permit
penetration of sufficient erythemal ultraviolet radiation to produce a
perceptible erythema for best tanning results. When used as directed, consumers
may remain in the sun for a predetermined time period without risking a
sun-burn. The sunburn protection is provided by sun-screen active ingredients,
e.g., cinoxate, homosalate, padimate O (octyl dimethyl PABA).
Suntan products claiming to prevent sunburn are also regulated as drugs if:
- The labeling bears any direct or implied statement that the product
screens out ultraviolet sunlight, prevents or treats sunburn, helps prevent
wrinkles, or prevents premature aging of the skin,
- The label bears a number representing the sun protection factor (SPF)
- The sunscreen ingredient is declared as an active drug ingredient and is
listed before the listing of the cosmetic ingredients (Section 502(c)(1) of the
FD&C Act and 21 CFR 702.3(d)).
Products regulated as cosmetics should, and those regulated as drugs must,
bear adequate directions for safe use (Sec. 502(f)(1) of the Act and 21 CFR
201.5). As an example, the label should state the maximum safe sun exposure
period under conditions of prescribed use. Suntan and sunscreen products also
must bear warning statements as necessary or appropriate to prevent health
hazards (21 CFR 740.1 and Section 502(f)(2) of the Act). The need for an
appropriate warning applies particularly to suntan products not containing a
sunscreen ingredient or providing only marginal sunburn protection (those with
SPF values of less than 4).
Other "suntan" products of interest are capsules intended for
ingestion and containing mostly beta carotene and canthaxanthin. These color
additives enter the blood stream and are partially deposited in skin tissue,
giving the skin a tan-like color. Neither color additive is approved for this
particular use, and products containing them are considered adulterated. Some
reports of adverse reactions associated with "tanning pills" have
mentioned stomach cramps, hepatitis, nausea, diarrhea, and deposition of the
color in the retina of the eye.
In recent years, "suntan accelerators" have appeared on the
market. They claim to enhance tanning by stimulating and increasing melanin
formation. Because their intended purpose is to affect a function of the human
body, they may be considered drugs. One type of suntan accelerator is based on
bergapten (5-methoxypsoralen) which is found in bergamot oil and is a well-known
phototoxic substance (responsible for Berloque dermatitis). Bergapten increases
the skin's sensitivity to ultraviolet light, intensifies erythema formation, and
stimulates melanocytes to produce melanin. It has also been reported to be
photo-carcinogenic in animals.
The other kind of suntan accelerator contains tyro-sine, alone or in
combination with other amino acids, as the "active" principle.
Tyrosine is the starting compound of the melanin synthesis in the skin. Its use
is based on the assumption that it penetrates the skin, increases the tyrosine
content of the melanocytes, and thus enhances melanin formation. This effect has
not been documented in the scientific literature. In fact, an animal study
reported a few years ago demonstrated that ingestion or topical application of
tyrosine has no effect on melanogenesis. The Agency has recently concluded that
"suntan accelerators" are unapproved new drugs within the meaning of
Section 201(p) of the FD&C Act, and has issued warning letters to several
major manufacturers of these products.
Permanently Listed Cosmetic Color Additives Subject To Certification
(August 10, 1994)
Color Additive Cosmetic Use* 21 CFR
FD&C Blue No. 1 Generally, including cosmetics74.2101
(including the intended for use in the areas of Aluminum Lake) the eye
FD&C Green No. 3Except eye area74.2203
FD&C Red No. 4 Externally except eye area74.2304
FD&C Red No. 40 Generally, including cosmetics74.2340
(including the intended for use in the area of Aluminum Lake) the eye
FD&C Yellow No. 5 Except eye area74.2705
FD&C Yellow No. 6 Except eye area74.2706
D&C Blue No. 4 Externally except eye area74.2104
D&C Brown No. 1 Externally except eye area74.2151
D&C Green No. 5 Generally, including cosmetics intended for use in the
area of the eye
D&C Green No. 6 Externally except eye area74.2206
D&C Green No. 8 Externally except eye area(0.01%maximum)74.2208
D&C Orange No. 4Externally except eye area74.2254
D&C Orange No. 5Externally except eye area74.2255
Lip products (5% maximum) Mouthwashes/dentifrices (GMP)
D&C Orange No. 10 Externally except eye area74.2260
D&C Orange No. 11 Externally except eye area74.2261
D&C Red No. 6 Except eye area74.2306
D&C Red No. 7 Except eye area74.2307
D&C Red No. 17 Externally except eye area74.2317
D&C Red No. 21 Except eye area74.2321
D&C Red No. 22 Except eye area74.2322
D&C Red No. 27 Except eye area74.2327
D&C Red No. 28 Except eye area74.2328
D&C Red No. 30 Except eye area74.2330
D&C Red No. 31 Externally except eye area74.2331
D&C Red No. 33 Externally except eye area74.2333
Lip products (3% maximum) Mouthwashes/dentifrices (GMP)
D&C Red No. 34 Externally except eye area74.2334
D&C Red No. 36 Externally except eye area74.2336
D&C Violet No. 2 Externally except eye area74.2602
D&C Yellow No. 7 Externally except eye area74.2707
D&C Yellow No. 8 Externally except eye area74.2708
D&C Yellow No. 10 Except eye area74.2710
D&C Yellow No. 11 Externally except eye area74.2711
Ext.D&C Violet no.2 Externally except eye area74.2602a
Ext.D&C Yellow no.7 Externally except eye area74.2707a
* As a general rule, color additives should not be exposed to oxidizing or
reducing agents that may affect the integrity of the color additives. Amounts of
color additives used in cosmetic products are restricted to levels consistent
with good manufacturing practice (unless the regulation specifies a maximum
Provisionally Listed Cosmetic Color Additives
Subject to Certification
Color Additive Cosmetic Use21 CFR
Lakes of As specified in listing of82.1051
FD&C Blue No. 1straight color in Part 74
FD&C Green No. 3
FD&C Red No. 4
FD&C Yellow No. 5
FD&C Yellow No. 6
D&C Blue No.4
D&C Green No. 5
D&C Green No. 6
D&C Orange No. 4
D&C Orange No. 5
D&C Orange No. 10
D&C Orange No. 11
D&C Red No. 6
D&C Red No. 7
D&C Red No. 17
D&C Red No. 21
D&C Red No. 22
D&C Red No. 27
D&C Red No. 28
D&C Red No. 30
D&C Red No. 31
D&C Red No. 33
D&C Red No. 34
D&C Red No. 36
D&C Violet No. 2
D&C Yellow No. 7
D&C Yellow No. 8
D&C Yellow No. 10
Ext. D&C Yellow No. 7Externally except82.2051
in eye area
Permanently Listed Cosmetic Color Additives
Exempt From Certification
Color Additive Cosmetic Use21 CFR
Aluminum powderExternally including eye area 73.2645
Annatto No restrictions73.2030
Bismuth citrateScalp hair dye only
(0.5% w/v maximum)73.2110
Bismuth oxychloride No restrictions73.2162
Bronze powder No restrictions73.2646
Caramel No restrictions73.2085
Carmine No restrictions73.2087
Carotene, Beta-No restrictions73.2095
Chromium hydroxide green Externally including eye area 73.2326
Chromium oxide greensExternally including eye area 73.2327
Copper powder No restrictions73.2647
DihydroxyacetoneExternally except eye area
(only for imparting color to
Disodium EDTA-copperCosmetic shampoo only73.2120
ferrocyanideExternally including eye area 73.2298
Ferric ferrocyanide Externally including eye area 73.2299
Guanine No restrictions73.2329
GuaiazuleneExternally except eye area73.2180
HennaScalp hair dye only 73.2190
Iron oxidesNo restrictions73.2250
Lead acetateScalp hair dye only73.2396
(0.6% Pb w/v maximum)
Manganese violetNo restrictions73.2775
Mica No restrictions73.2496
Potassium sodiumCosmetic dentifrices73.2125
copper chlorophyllin(0.1% maximum)
(chlorophyllin-copper(required combination with
complex) specified substances
PyrophylliteExternally except eye area73.2400
SilverNail polish only (1% maximum) 73.2500
Titanium dioxideNo restrictions73.2575
Ultramarines (blue, green, Externally including eye area 73.2725 pink, red,
Zinc oxideNo restrictions73.2991
How to Obtain FDA Regulations
Regulations published by the Food and Drug Administration are codified under
Title 21 Code of Federal Regulations. Before codification, regulations are
published in the Federal Register, first as proposed regulations and then as
final rules. Both, the Code of Federal Regulations and the Federal Register,
may be purchased with VISA copyrighted or MasterCard copyrighted or by
submitting a check or money order to the Superintendent of Documents, Government
Printing Office, Washington, DC 20402, telephone 202-783-3238. Contact the
Government Printing Office directly for current costs.
Title 21, Code of Federal Regulations
Title 21 of the Code of Federal Regulations is updated each year in April.
It consists of eight volumes which may be purchased singly or as a set. The
individual volumes consist of:
Parts 1 to 99. General regulations for the enforcement of the Federal Food,
Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling ACT
(FPLA). Color additive Regulations
Parts 100 to 169. Food standards, good manufacturing practice regulation
for food, infant formula regulations, food labeling regulations.
Parts 170 to 199. Food additive regulations
Parts 200 to 299. Drug labeling regulations, good manufacturing practice
regulations for drugs.
Parts 300 to 499. Regulations covering drugs for human use.
Parts 500 to 599. Regulations concerning animal drugs, feeds and related
Parts 600 to 799. Regulations concerning biological products and cosmetics.
Parts 800 to 1299. Regulations concerning medical devices and radiological
health. Regulations published under the authority of laws other than the FD&C
Act and the FPLA.
The Federal Register is published daily, Monday through Friday. It is
mailed, postage paid, to subscribers. There is a 25% surcharge for foreign
mailing. It is also available on microfiche.
Main Page | About Grimes & Reese | Practice Areas | MLM Law Clients | MLM Articles
MLM Law Library | What Our Clients Say | What's New | Search MLM Law | MLM Law Blog | Site Map