Cosmeceuticals: myths and misconceptions
Clinics in Dermatology (2009) 27, 446–452
Department of Dermatology, St. Luke's Roosevelt Hospital Center, 1090 Amsterdam Avenue, Suite 11D, New York, NY 10025, USA
Abstract Cosmeceuticals, or physiologically active cosmetics, are subject to many misconceptions.
Most consumers mistakenly believe that cosmeceuticals are regulated and tested as drugs. They alsobelieve that the ingredients and final products have been tested for safety and that the claims made inadvertisements are valid. Although cosmeceuticals and pharmaceutical ingredients have never beencloser together, their regulatory environments are vastly different due to the distinct Congressionalmandates given the Food and Drug Administration. Physicians are in a good position to help patientsand potential cosmeceutical users understand the benefits and realistic limitations of these products.
2009 Elsevier Inc. All rights reserved.
No market regulated by the United States (U.S.) Food and
beyond the time of application. These definitions imply a
Drug Administration (FDA) is more affected by fashion and
physiologic or pharmacologic action.
whim than the cosmetic industry. The cosmetic market is big
With the exception of tretinoin and tazarotene the products
business, responsible for billions of dollars of consumer
in this class are sold over-the-counter (OTC) and are
spending in the United States aloneIt is subject to myths and
regulated as cosmetics, not pharmaceuticals. The government
misconceptions, in part because of aggressive and competitive
does not recognize a separate “cosmeceutical” category. This
marketing tactics. Implied claims of potency and effectiveness
fact affects the type of product testing done, the format and
can easily mislead the consumer and professional, alike.
substantiation of claims, and the language used in promotion
The term “cosmeceutical” was coined in 1961 by
of the products. Lack of awareness of this important issue
Raymond Reed, founding member of the U.S. Society of
among physicians, skin care professionals, and consumers
Cosmetic Chemists.He originally conceived the word to
has led to many misunderstandings about cosmeceuticals.
describe “active” and science-based cosmetics. The word and
Some of the most common myths and misconceptions, all
concept were further popularized by Dr Albert Kligman in
the late 1970s, with the development of prescription-strengthtretinoin for the enhanced appearance of ultraviolet (UV)
• Cosmeceuticals and cosmetics are regulated as drugs.
damaged and wrinkled skin. Common usage has expanded
• Cosmeceutical claims in labeling and advertising are
the definition to include “a cosmetic that has or is purported
substantiated and approved before market.
to have medicinal properties.” The cosmetic industry uses the
• Cosmetic ingredients undergo premarket testing and
term to indicate those products that affect the health of skin
or that have a sustained effect on the skin's appearance
• Cosmetic ingredients undergo premarket testing and
• “Natural” products are safer than synthetic.
⁎ Dermatology Consultants of Westchester, 2 Overhill Road, Scarsdale,
• “Cruelty-free cosmetics” have had no animal testing,
0738-081X/$ – see front matter 2009 Elsevier Inc. All rights reserved.
• Hypoallergenic means that the product has been tested
were used to clean or change the appearance of the skin by
to remove all allergenic materials and the product will
be tolerated by the allergic or sensitive individual.
Congress specifically put more stringent controls on the
manufacture and preparation of foods and drugs than on
The following review of the history cosmetic regulation
cosmetics because of the potential greater hazard from
and the current regulatory framework will help to clarify
ingestion of substances than from the application of products
used for personal grooming or beautification. Through theFDCA and its amendments, the FDA was authorized toregulate aspects of cosmetic safety, manufacture, ingredients,labeling, and advertising. An overview of the current state of
affairs of regulation of cosmetics follows.
Cosmetics were unregulated in the United States 80 years
ago; however, the 16 cases of blindness associated with the
use of Lash Lure Eyelash aniline dye in the 1930s impelledCongress to take action to protect the American public. Theresulting passage of the (Copeland-Lea) Federal Food, Drug,
Product safety is difficult to ensure because the FDCA did
and Cosmetic Act of 1938 (FDCA),set the regulatory
not mandate premarket approval of cosmetics, which is in
infrastructure for cosmetics, based on the prevailing knowl-
sharp contrast to the tightly controlled marketing of drugs.
edge. It was modified in 1960 by the Color Additives
Congress did not discuss how the FDA should ascertain
and again in 1966 by the Fed. Fair Packaging
cosmetic product safety; there are no defined measures for
and Labeling Act,which set forth further FDA mandates.
safety testing. The FDA requires that if the product
At the time that the Food, Drug, and Cosmetic Act was
incorporates untested ingredients or if the final product is
passed, not much was known about the normal physiology of
untested, a safety warning must be placed on the products
the skin, and far less was known about the effect of topically
that states: “Warning—the safety of this product has not been
applied hygienic or decorative products on the skin. Most of
determined.”The actual types of testing, and the adequacy
the study of the structure and function of skin was oriented
and rigor of testing, are left to the discretion of the
towards disease processes. Normal skin was viewed as
having an almost “Saran Wrap” like function.
Today, we know much more about the function of healthy
skin, partly because of the plethora of research conducted in
cosmetic industry laboratories as well as from industrysupport of basic science investigations in university and
The FDA is empowered to prevent adulteration and
other institutional settings. We also now know that many
misbranding of the product. To facilitate safe product
cosmetics, formulated of ingredients “generally recognized
manufacturing practice, because it has not been mandated
as safe” (GRAS), certainly do affect the structure and
to issue definitive regulations, the FDA has issued good
function of skin and that there are many well-studied actives
manufacturing practice (GMP) guidelines, which are pat-
that offer more than just adornment or cleansing of the skin.
terned after the food GMP regulations. These guidelines state
These factors, however, were not a consideration in 1938
that products must be prepared in a clean environment under
when Congress defined the words, “drug” and “cosmetic”
sanitary conditions and must not contain any poisonous,
with a clear-cut distinction. According to the statutory
filthy, putrid, decomposing, or otherwise deleterious sub-
definition, drugs are “articles intended for use in the
stances in order to avoid adulteration.
diagnosis, cure, mitigation, treatment or prevention of
The FDA refers to both the Bacteriologic Analytical
disease in man… and articles intended for use as a component
Manual, published by the Association of Official Analytical
of any such articles.” a Another part of the statutory drug
Chemists, and the Cosmetic, Toiletry, and Fragrance
definition states that any substance that is intended to alter
Association (CTFA) guidelines for its guidance documents.
the structure or any function of the body of man (including
Misbranding refers to misleading or incomplete information
physiologic processes thereof) is also considered to fall
on package labeling, improper labeling of ingredients, or
Cosmetics are “articles intended to be rubbed, poured,
sprinkled, or sprayed on, introduced into, or otherwiseapplied to the human body or any part thereof for cleansing,
beautifying, promoting attractiveness, or altering the appear-ance and articles intended for use as a component of any such
According to FDA guidelines, any component ingredient
article, except that such term shall not include soap.” c Thus,
may be used as long as it is “safe.” A precise review of
drugs were used to treat and prevent disease, and cosmetics
selected ingredients is done by the Cosmetic Ingredient
Review (CIR) Expert Panel. The CIR was established by
print and electronic advertising; the FDA regulates the
the CTFA and the Consumer Federation of America in
package labeling, which includes the product package, any
1976. The panel meets frequently to assess cosmetic
insert and instructions, and the Web site, under certain
ingredients in an unbiased, open, and expert manner, after
circumstances, so there is considerable overlap. The FDA
which the results are published. The review list is
is mandated to prohibit “misbranding.” This means that
prioritized by the extent to which the public is exposed
the label must not be misleading or false, must contain the
to the ingredient and its potential biologic activity.
accurate product identity and all the other labeling
Thousands of ingredients are used in modern cosmetic
information, and must not contain any nonapproved
manufacturing that are GRAS substances, based on industry
testing many years ago and historical Thus far, theCIR has only been able to definitively review hundreds ofthem. Ingredient safety remains an issue both in the United
Some companies that promote their products as
“cruelty-free” or “not tested on animals” do not display
Today, cosmetics are regulated by the FDA's Center for
the warning label that the safety of the product has not
Food Safety and Applied Nutrition (CFSAN). OTC drugs
been established. They either rely on the suppliers of
that may also have a cosmetic function are regulated jointly
ingredients or contract with outside laboratories to do the
through the Center for Drug Evaluation and Research and
animal testing. Others may use historical studies of similar
CFSAN. CFSAN fulfills its broad responsibilities by issuing
products, or may use the literature, raw material safety
guidelines and performing field inspections, surveillance,
testing, or perform clinical human safety testing to satisfy
and registration of manufacturers through the Voluntary
the safety Most raw materials used by these
Cosmetic Registration Program, which registers the sites of
companies were tested in animals years ago, which has
manufacture as well as the formulation and raw material
been recognized as the gold standard.
composition of the CFSAN also keeps product
Unlike other ingredients, the FDA exerts strict regulatory
experience reports, which are reported to the CFSAN
control over coloring agents used in cosmetics as well as a
Adverse Experience Reporting System. Much of its regula-
small number of banned or restricted ingredients.Of all the
tion of cosmetics involves postmarket enforcement because,
ingredients in use, colors are the only ones that must be
as has been emphasized, it does not have the premarket
preapproved. All batches of petroleum-derived color addi-
statutory authority to approve cosmetic products, cosmetic
tives (except for hair dyes) must be tested and certified in the
FDA Color Certification Branch Laboratories before being
Time is allocated each year by the field staff for routine
sold. Particular colors are approved for specific end uses, for
inspections and investigations of the regulated products. The
example, for coloring the final formulation vs making a
resources devoted to its enforcement efforts are somewhat
colored decorative cosmetic.Of particular note is that none
limited, however, because of higher-priority obligations,
including concerns about drugs, devices, biologics, fooddefense, and safety, Thus, the field offices are directed to
inspect the cosmetic firms with the greatest potential forhealth hazard, such as producers of eye area products or
Labeling laws were established to help the consumer
those that have had past violations. Inspections may be
make value and function comparisons. They were also
triggered for other reasons, such as notification to the FDA of
created to enable the consumer to avoid potential allergens.
a complaint or adverse event from a consumer, health
Accurate labeling includes clear placement on the product
professional, or industry. In addition, a voluntary recall of a
label of its identity, the name and address of the
product, ongoing compliance situations, and follow-up to
manufacturer, the distributor, the quantity of the product
product promotion or scientific studies, may all lead to an
contained therein, and the ingredients listed in rank order,
using specific nomenclature, to 1%. Trade secrets and
Violators of the adulteration and misbranding provisions
specific flavorings or fragrances are exempt from this and
of the FDA may be subject to a variety of enforcement
may be listed as “other ingredients” or may be listed in any
tools, including formal correspondence such as warning
order at concentrations of less than 1%. All safety warnings
letters, which may be on the FDA Web site, and
related to the use of the product must also be placed
publication in the press, product recalls and seizures,
targeted establishment inspections, and sampling pro-If a product has been misbranded or adulterated,
the FDA may request a “voluntary recall.” The productmay be seized if there is a serious violation, and an
Truthful advertising is coregulated by the Federal Trade
injunction may be issued against further commercial
Commission and the FDA. The FTC regulates
operations. Rarely, criminal prosecution ensues.
Recent examples of warning letters on the FDA Web site
The primary reason companies try to avoid a drug claim is
include products that have been found to have bacterial
economic. There are multiple regulatory interfaces within the
contamination and incorrect ingredient listings. A well-known
drug approval process and, in contrast, few hurdles in
example of a seizure is case from the 1990s of Rio Hair
Relaxer, imported from Brazil. It was removed from the U.S.
An example is the time and expense required to bring
market because its use resulted in hair loss, severe dermatitis,
Renova to the market. Its active ingredient, tretinoin, was
and hair discoloration for more than 3000 peopl
already legally marketed for decades as a treatment for acne
Another, more complex case and recent seizure is that
vulgaris (as Retin-A), with a well-established safety profile.
of Age Intervention Eyelash, manufactured by Jan Marini
It took almost a decade and millions of dollars before the
Skin Research, San Jose, California. The product, which
approval was granted this drug for cosmetic use in wrinkle
was promoted as a cosmetic that increased eyelash growth,
smoothing and for treatment of tactile roughness, mottled
contained bimatoprost, a prostaglandin analog drug that is
hyperpigmentation, and correction of photodamage indica-
FDA-approved to treat glaucoma. Bimatoprost has well
tions. The important distinction is that although the product
known side effects of darkening and lengthening lashes,
was marketed for cosmetic “indications,” it was never
the iris, and periocular skin. Potential side effects could
also include compromised vision in those already receivingthe drug for medical purposes. It was seized by the FDAfor the unapproved use of a drug active ingredient (ie, asan adulterated cosmetic) as well as for misbranding
because it was promoted to alter the structure of a tissuein the body.Subsequently, a bimatoprost solution product
To legally market a drug, a manufacturer must submit to
has received FDA approval for this same purpose, but as a
the FDA a premarket application (PMA). The PMA includes
drug, not a cosmetic. Studies were submitted to the FDA
defined clinical studies documenting safety and efficacy for a
with the rigor required for drug approval.
specific indication, with statistical significance (P b .025).
The efficacy is determined by a specified end point (eg,microbiologic cure, cancer remission), depending on theclass of drug.In contrast, no preapproval is necessary to
market a cosmetic,and no predetermined end point isnecessary for efficacy or product claims.
Data now show that many cosmetic products, previously
For a pharmaceutical drug, safety studies are required to
thought to be inert, have an effect on the structure or function
generally include animal, toxicology, pharmacokinetics,
of skin. The classification of a product has tremendous
pharmacology, drug-drug interaction, and other relevant
ramifications on its production and marketing. In general, the
data. In comparison, a cosmetic must be safe for intended
FDA reviews the types of product claims made to determine
use, but there is no definition of safety and there is great
The FDA is guided by the intended use, which is inferred
Another important aspect of marketing a product is its
from promotional materials such as the labeling, advertise-
label. A drug has extremely complex labeling requirements,
ments, oral and written statements, and testimonials.These
with an extensive package insert that includes a description
can be used as evidence of drug intent, even if the
of the chemical structure of the active ingredient, formula-
manufacturer issues a disclaimer. In many cases, however,
tion, strength, additives, clinical pharmacology, mechanism
no clear line of differentiation exists between cosmetic and
of action, indications for use, contraindications, precautions,
drug claims. The cases are reviewed individually based on all
warnings, adverse reactions, dosage, and forms. The
of the involved facts, not on a simple phrase taken out of
requirements for labeling of a cosmetic are well defined by
context, but instead on how the product in total is labeled and
regulation, but are far less complex, as previously noted.
promoted. This is similar to Supreme Court Justice Potter
Pharmaceutical manufacturing facilities have a mandatory
Stewart's statement regarding pornography, “I shall not
registration and inspection requirement that may be repeated
today attempt further to define the kinds of material I
every 2 years. GMP regulations apply. The cosmetic facility
understand to be embraced… but I know it when I see it.”
should follow the GMP guidelines and should comply with
Manufacturers have some latitude to engage in hyperbole
the Voluntary Cosmetic Registration Program, but can expect
and “creative” marketing about the benefits of the product,
but they cannot engage in misrepresentation or impute
All drug ingredients must be preapproved, including active
physiologic or therapeutic properties to a product. If they
ingredients and fillers, which are often from the GRAS list.
make physiologic (eg, disease prevention) or pharmacologic
Any change in formulation must be reviewed by the FDA. This
claims, they must then comply with the drug or device
is clearly distinct from the cosmetic ingredient regulations,
provisions of the FDCA. Most manufacturers would like to
where a change in formulation is a matter of course—a
prevent their products from being labeled “drugs.”
business decision—and not reviewed with the FDA.
The FDA closely monitors the language of drug market-
and in vitro systems is the inability to accurately
ing claims to ensure that approved indications are correctly
assess percutaneous penetration in humans. The
promoted in advertisements and labeling. The adept drug
claims obtained from these studies focus on
manufacturer consults with the FDA before issuing labels
and launching advertising because it understands the level of
3. Subjective assessment is generally a sensory
regulatory scrutiny is high and the consequences are costly.
evaluation. It is valuable, because the consumer
In contrast, cosmetics claims are seldom monitored and are
may perceive changes before they are clinically
only investigated if brought to the attention of the
evident to the observer. Types of claims from this
appropriate agency. There is no statutory mandate allowing
testing include statements like “feels softer,
the FDA to monitor performance advertisements and no
smoother, looks more radiant” and also includes
“appears to reduce the appearance of…” or “helps
The time and cost for drug development are in sharp
contrast to those of cosmetics. The average time for drug
4. Product formulation claims, such as “contains
development is from 7 to 15 years from the laboratory to the
X, contains 5% of aloe vera, more concentrated,”
pharmacy shelf. The time for cosmetic development of a
relate to the constituents of the product. Of
breakthrough technology is 3 to 5 years. The average cost of
course, the active ingredient must be stable in the
research and development for a new drug is $800 million.
final formulation, able to penetrate the corneum,
In contrast, the cost of creating and developing a break-
and be biologically active at the target site for
through cosmetic technology is between $2 and $3 million
clinical benefits to ensue. The consumer may be
(personal communication: Maria Corbiscello, January 22,
unaware of the effectiveness of the ingredient in
2007 Studio MC2). The costs, time, and effort expenditures
are why the drug classification is avoided by the cosmetic
5. Performance characteristics may be assessed with
industry and why it actively works to prevent the imposition
use tests such as the 28-day repeat insult patch test
of further regulation of their products.
or open patch testing. These may generate claimssuch as “gentler,” “milder,” and “noncomedogenic.”
“Unscented” is a straightforward performanceclaim. “Hypoallergenic” has no federal definition
or standard and can mean whatever the manufac-turer wants it to
Product claims are the cornerstone of effective marketing
6. Endorsement claims include testimonials by citi-
in the cosmetic industry. To support their product perfor-
zens and celebrities, “tested by dermatologists,” and
mance claims, cosmetic companies rely on a variety of
“developed by dermatologists.” Increasing numbers
of physician named or associated brands arepromoted for the marketplace. Many of these
1. Clinical evaluation is meaningful when it is
physicians are actually paid “spokesdoctors.” Pro-
blinded, controlled, and when clinical grading is
ducts are also labeled with various institutional “seal
done by an expert, unbiased evaluator. “Antiwrin-
kle,” “shinier hair,” and “smoother skin” are
7. Cultural claims include “100% natural ingredients”
examples of the claims that may be made from
8. Superiority claims include “milder than…,” “more
2. Instrumental assessment can provide insights into
soothing than.,” “more hydrating.” etc. The
the mechanism of action of the product and can
manufacturer must be prepared to substantiate the
objectively measure its physiologic effects. Instru-
mentation found in the industrial laboratory
9. Emotive claims such as “Because I'm worth it
commonly includes techniques to determine trans-
(L'Oreal)” or “you'll look like a million dollars” do
epidermal water loss, barrier function, surface
irregularities, wrinkle depth, skin firmness, elasti-
10. Preference claims should be documented with a
city, and epidermal turnover. These tests are often
performed in volunteers, but may include animal
11. Mind claims are a new area relating to how the
and in vitro studies. The latter are interesting but
product makes one feel. Some may consider them a
have less real-world application. A limitation of
subclass of subjective assessment claims, but they
both in vivo and in vitro studies is that one cannot
are based on innovative assessment tools, including
do a placebo control. Because even bland sub-
detailed questionnaires and instrumentation such as
stances have an effect on the structure and function
of skin, controls are generally obtained from the
12. “Puffery” claims are those which make fanciful or
vehicle. A major limitation of both animal models
outrageous claims.Puffery is a legal term that
refers to promotional statements and claims that
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tions, i.e., those that the ordinary consumers do not
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Nongovernmental controls also exist on product promo-
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tional claims. The National Advertising Division (NAD) of
8. Fair Packaging and Labeling Act (FPLA), 15 U.S.C. Sec. 1451 et seq.
the Council of the Better Business Bureaus is a self-
FDA Web site. Available at: . Accessed June 16, 2009.
regulating organization that evaluates claims for truth and
9. Federal Food, Drug, and Cosmetic Act (FDCA), a. 21 U.S.C. §321(g);
accuracy. If a promotional claim is found to be questionable
b. 21 U.S.C. §201(g)(1)(c); c. 21 U.S.C. §321(i).
and cannot be satisfactorily resolved by the NAD Case
10. Code of Federal Regulations. 21 C.F.R. §740.1.
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The cosmetics industry today holds a unique position.
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Cosmetic companies are permitted to create and market
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genic” claims are truthful and substantiated. The reality is that
19. Federal Trade Commission Act, 15 U.S.C. §§45 and 55.
active cosmeceutical and pharmaceutical ingredients have
20. Federal Food, Drug, and Cosmetic Act (FDCA), 21 U.S.C. §362(a-(f)).
never been closer together than today. This evolving field was
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