DEFINITIONS OF COSMETICS

The word cosmetic derives from the Greek Kosm tikos meaning 'having the power, arrange,
skilled in decorating', giving kosmein, 'to adorn' and kosmos, 'order', 'harmony'.

1. DRUGS AND COSMETICS ACT- India

a. Cosmetics

Any article intended to be rubbed, poured, sprinkled or sprayed on, or introduced into, or
otherwise applied to, the human body or any part thereof for cleansing, beautifying, promoting
attractiveness, or altering the appearance, and includes any article intended for use as a
component of cosmetic.

b. Misbranded Cosmetics
A cosmetic shall be deemed to be misbranded—
a) if it contains a colour which is not prescribed; or
b) if it is not labelled in a prescribed manner; or
c) if the label or container or anything accompanying the cosmetic bears any
statement which is false or misleading in any particular

c. Spurious Cosmetics

A cosmetic shall be deemed to be spurious:

a) if it is imported under the name which belongs to another cosmetic; or
b) if it is an imitation of, or is a substitute for, another cosmetic or resembles
another cosmetic in a manner likely to deceive or bears upon it or upon its label
or container the name of another cosmetic, unless it is plainly or conspicuously
marked so as to reveal its true character and its lack of identity with such other
cosmetic; or
c) if the label or the container bears the name of an individual or company
purporting to be the manufacturer of the cosmetic, which individual or company
is fictitious or does not exist; or
d) if it purports to be the product of a manufacturer of whom it is not truly a
product.

2. EUROPEAN GUIDELINES

The European Union Cosmetics Directive defines a cosmetic as "any substance or preparation
intended to be placed in contact with the various external parts of the human body (epidermis,
hair system, nails, lips and external genital organs) or with the teeth and the mucous
membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming
them, changing their appearance and/or correcting body odours and/or protecting them or
keeping them in good condition. "
The European Union requires that cosmetic products placed on the EU market be safe;
that is, they "must not cause damage to human health when applied under normal or reasonably
foreseeable conditions of use

3. FDA

The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their
intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced
into, or otherwise applied to the human body...for cleansing, beautifying, promoting
attractiveness, or altering the appearance" [FD&C Act, sec. 201(i)]. Among the products
included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye
and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and
deodorants, as well as any substance intended for use as a component of a cosmetic product.

Can a product be both cosmetic and drug?

Some products meet the definitions of both cosmetics and drugs. This may happen when a
product has two intended uses. For example, a shampoo is a cosmetic because its intended use
is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat
dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other
cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also
antiperspirants, and moisturizers and makeup marketed with sun-protection claims. According
to FDA, such products must comply with the requirements for both cosmetics and drugs.

How are approval requirements different?

Under the FD&C Act, cosmetic products and ingredients, with the exception of color additives,
do not require FDA approval before they go on the market. Drugs, however, must generally
either receive premarket approval by FDA through the New Drug Application (NDA) process

Drugs vs Cosmetics
1. Definition:

• Drug: articles intended for use in the diagnosis, cure, mitigation, treatment, or
prevention of disease" and "articles (other than food) intended to affect the structure
or any function of the body of man or other animals"
• Cosmetics: See above
2. Cosmetics do not require FDA approval for marketing
3. Though GMP guidelines are available for Cosmetics, however these are guidelines and
no strict adherence is necessary.
4. Cosmetics are sold OTC unlike most of the drugs
 COSMACEUTICALS

What are Cosmeceuticals?

Cosmetics + Pharmaceuticals = Cosmeceuticals

These are topical cosmetic-pharmaceutical hybrids intended to enhance the beauty through
ingredients that provide additional health-related function or benefit. They are applied topically
as cosmetics, but contain ingredients that influence the skin/hair’s biological function.

Regulatory Status of Cosmeceuticals

Unlike drugs, cosmetics are not subject to mandatory FDA review. Much confusion exists
regarding the status of ‘cosmeceuticals.’ Although there is no legal class called cosmeceuticals,
this term has found application and recognition to designate the products at the borderline
between cosmetics and pharmaceuticals. Cosmeceuticals are not subject to FDA review and
the Federal Food, Drug and Cosmetic Act do not recognize the term itself. It is also often
difficult for consumers to determine whether ‘claims’ about the actions or efficacies of
cosmeceuticals are in fact valid unless the product has been approved by the FDA or equivalent
agency. Some experts are calling for increased regulation of cosmeceuticals that would require
only proof of safety, which is not mandatory for cosmetics. Some countries have the classes of
products that fall between the two categories of cosmetics and drugs: for example, Japan has
‘Quasi-drugs’; Thailand has ‘controlled cosmetics’ and Hong Kong has ‘cosmetic-type drugs.
The regulations of cosmeceuticals have not been harmonized between the USA, European,
Asian and other countries.

Cosmetics vs Cosmeceuticals

Cosmetics or beauty products will not cause the skin to change or heal; these products are just
meant to cover and beautify. Cosmeceuticals being cosmetic products having medicinal or
drug-like benefits are able to affect the biological functioning of skin owing to type of
functional ingredients they contain. There are skin-care products that go beyond coloring and
adorning the skin. These products improve the functioning/texture of the skin by encouraging
collagen growth by combating harmful effects of free radicals, thus maintaining keratin
structure in good condition and making the skin healthier.

Examples of Cosmeceuticals

• Sunscreens: Titanium dioxide, PABA derivatives

• Skin-whitening Agents: Kojic Acid, Hydroquinone

• Antiaging Products: Estrogen Creams, Vitamin A and E

 • Anti-dandruff agents: Zinc-pyrithone, octopirox

Cosmeceuticals vs Drugs

• Unlike drugs there is no legal class called Cosmeceuticals. Some countries have the
classes of products that fall between the two categories of cosmetics and drugs: for
example, Japan has ‘Quasi-drugs’; Thailand has ‘controlled cosmetics’ and Hong
Kong has ‘cosmetic-type drugs.
• Cosmeceuticals are not subject to mandatory regulatory review
• Safety and Efficacy profile do not exist for cosmeceuticals

Future of Cosmeceuticals

Cosmetic companies are finding ways to deliver small-dose ingredients that do not require
medical regulations and to introduce steroids and hormones into lip balms, which would result
in production of cosmeceuticals that could help to improve body mass, nail, and hair growth.
New challenges will also be presented to government regulatory agencies as more chemicals
with true biological activity are invented and tested. Claim substantiation and premarketing
testing must also evolve to accurately assess efficacy and safety issues with important
implications for total body health. The new vehicles and delivery systems combined with
established ingredients will alter percutaneous absorption, requiring re-evaluation of
substances with an assumed good safety profile. Biotechnology will also compete directly with
the pharmaceuticals and cosmetic businesses. The most influential angle over the coming 5
years will be the links between internal health, beauty, and anti-aging. The next big beauty
trend will include skingestibles that will promote beauty from the inside out, borrowing of
pharmaceutical terms for cosmetic applications, amino peptides to make the skin more elastic,
neuro mediators which are chemicals to tell the brain to be happy and the blurring of boundaries
between surgery and cosmetics. The trend towards therapeutic cosmetics is sure to result in the
need to obtain a better understanding of modern ingredients and assessment techniques.
 EVOLUTION OF COSMECEUTICALS

A. PREHISTORIC TIMES – 3000 BC

Cave man coloured his skin for protection from animals or enemy either as camouflage or to
provoke fear. Egyptian, Indian and Chinese ancient civilisations used aromatic oils, incenses
and colours. The colours used were made by crushing the rocks or from plants. Excavations in
the Indus Valley have yielded cosmetic pots of clay, stone, ivory, faience. Sindoor finds
mention even in ‘Mahabharatha’.

B. HISTORC TIMES TO MIDDLE AGES

In ancient Indian tradition, colour, aromas, soaps etc. have been part of religious rites. Romans
used to adorn themselves before going to war. Greeks used flowers on monuments of dead as
mark of respect. Egyptian invented the public bathing and emphasized the need of cleaning the
body. Discorides’ ‘Materia Medica’ is full of details of many cosmetics of herbal origin.

The Hindus used betel juice to darken the lips and teeth; vermilion and other colours in
waxes for the face to denote caste; and quantities of aromatics for family celebrations such as
weddings and births. while barbaric tribes were over-running Europe from the north and east,
and bringing about the Dark Ages, there was a spread of learning and a thirst for knowledge
throughout Asia.

In the crusade years, the cosmetics entered the European world. A brighter side of the crusades
were the perfumes and toiletry articles introduced into western culture from the eastern harems
and as a result of the opening up of trade with Arabia, India and southern Asia. China also
became a world leader in exporting herbal drugs and cosmetics in these years. The wrath of
Chenghez Khan brought these drugs and herbs to wherever he went.

C. MODERN TIMES
It was Queen Elizabeth’s desire to always look graceful that made the art of beautifying a
separate profession. Shakespeare’s plays brought the make-up into theatres. With industrial
revolution, cosmetic industry has made a foray into business. With advent of globalisation, the
reach of such industry has broken the barriers of borders. A lot of literature is available on this
now. From traditional and religious realms, cosmetics has now entered into realm of science
and technology.
 COSMETICS AS QUASI-DRUGS

There is a thin line between drugs and cosmetics, which can be considered as quasi-drugs. In
Japan and South-Korea, a separate category is made for cosmetics which are termed as quasi-
drugs.

Quasi-drugs are products which are used for cosmetics purposes but are suitable for preventing
and improving symptoms as they contain certain medicated ingredients. However, they do not
have as strong effect as drugs. So they are termed quasi-drugs. They are different from drugs
in following ways:
• Benefits not as suitable as drugs
• Their efficacy is not supported by strong data as in clinical trials for drugs
• Quasi-drugs are generally OTC products
• They are not subject to stringent regulatory review as in drugs

In South. Korea, quasi-drugs are classified into two coordinates:

CLASS I

• Items used for sanitary purposes such as sanitary pads, tampons, and menstrual pads
• The textile used for manufacturing masks such as dust and surgical masks
• Wet wipes for oral hygiene
• Sanitary products used for protection, preservation, and treatment of affected areas
that includes different kinds of bandages such as eye bandage, plastic bandage,
cylindrical elastic bandages, and elastic bandages. Absorbent cotton, gauze, and
plaster are also a part of it.

CLASS II

• Odor inhibitors like toothpaste, antiperspirants, and bath products

• Hair care products that are only meant for external usage
• Contact lenses
• Ointments and anti-inflammatory products for external use
• Products for oral hygiene such as teeth whiteners, vitamin tablets, and energy drinks
• Disinfectants

However, it is equally true that there is an urgent need to harmonise the guidelines on cosmetics
world over. Regulatory authorities have to ponder over bringing the cosmeceuticals and quasi-
drugs into stringent regulatory scanner so as to make sure that pharma companies do not get
away by labelling their products as quasi-drug or cosmeceutical.
 OTC COSMETICS

OTC (over-the-counter) medicines are safe and effective drugs used by the general public
without prior recourse to a healthcare professional.
Similarly, certain cosmetic-drug combination products can be considered as OTCs.
For example, in the U.S., antidandruff shampoos and sunscreen products are considered to be
OTCs. OTCs must be manufactured and controlled in accordance with cGMP requirements for
pharmaceuticals for human consumption.

The FDA has published several Over The Counter (OTC) categories monographs of
nonprescription Drugs treatments such as acne, dandruff, seborrheic dermatitis, psoriasis
medications and sunscreens.

Cosmetic products formulation registration is not mandatory but for cosmetic OTC products
manufacturers are obligated to register their Drug products (FDA) including Drug active
material being added to the Cosmetic product.