Introduction Phar 566
Introduction Phar 566
Natural
Cosmetics
! Natural
products form a large and diverse
group of compounds derived from sources
encompassing the plant and animal
kingdoms examples of which include
among others, insects, marine algae and
microbes.
Natural products (2)
! Commonly used ingredients comprise
herbs, minerals, vitamins, antioxidants,
essential oils, enzymes and hormones that
have become increasingly more popular
in cosmetic and personal care products
due to the increasing number of reports
concerning the potential harmful effects of
some synthetic ingredients on the human
body.
Natural products (3)
! Stem cells are another natural source that
is gaining enhanced popularity in the
cosmetic field.
! Stem cells carry inherent implausible
capabilities for applications in skin care for
both dermaceuticals and cosmeceuticals.
Organic Products (1)
! The term “organic” is not defined in any of
the FDA’s laws or regulations.
! However, the term is regulated by the
Agricultural Marketing Service of the US
Department of Agriculture (USDA) as it
applies to agricultural products through its
National Organic Program (NOP)
regulation.
Organic Products (2)
! In addition to agricultural products
(organic foods and beverages), the USDA
also certifies cosmetics and personal care
products if they contain or are made of
agricultural ingredients and can meet the
USDA/NOP organic production, handling,
processing, and labeling standards.
Organic Products (3)
! The USDA has four categories of
ingredients/ products based on the
amount of organic ingredients in a
product and other factors.
! The categories are the following: 100%
organic, organic, made with more than
70% organic ingredients, and made with
less than 70% organic ingredients.
Organic Products (3)
! Products in order to be labeled “100% organic”
must contain only organically produced
ingredients. These products can display the USDA
organic seal.
! Products in the “organic” category must contain
at least 95% organically produced ingredients. The
regulation has requirements for the remaining 5%
as well. These products can also display the USDA
organic seal.
Organic Products (4)
! Productsin the “made with more than 70%
organic ingredients” contain at least 70%
organic ingredients. They can be labeled
“made with organic ingredients.” These
products can list up to three of the organic
ingredients on the principal display panel.
The products may not display the USDA
organic seal.
Organic Products (5)
! Products in the last category cannot use
the term “organic” anywhere on the
principal display panel.
! They may identify specific ingredients that
are USDA certified on the information
panel. These products may not display the
USDA organic seal.
Nutraceuticals (1)
! There is a distinct category of products, known as
dietary supplements or nutraceuticals, that are
often thought to be cosmetics by consumers
based on the claims heard on TV and seen on the
Internet and printed media (i.e., “beauty from the
inside out” and “beauty from within”).
! These products often claim to make the hair, skin,
and nails look healthier, shinier, and stronger.
Although they may be believed to be cosmetics,
dietary supplements represent a specific category
separate from foods, drugs, and cosmetics.
Hypoallergenic Products (1)
! Hypoallergenic cosmetics are products claimed to
produce fewer allergic reactions than other non-
hypoallergenic cosmetic products. Consumers with
hypersensitive skin and even those with normal skin
may be led to believe that these products will be
gentler to their skin than non-hypoallergenic
cosmetics.
! However, it should be noted that there is no federal
standard or definition for the use of the term
“hypoallergenic.” The term means whatever the
particular company or consumers want it to mean.
Hypoallergenic Products (2)
! Manufacturers of hypoallergenic cosmetics are not
required to submit data and test results to the FDA
to substantiate their hypoallergenicity claims.
! The term usually refers to products that do not
contain ingredients known to cause allergic
reactions, such as fragrances. However, as the use
of the term is not regulated, it is recommended
that consumers with sensitive skin check the list of
ingredients on cosmetic labels and see whether
there are any ingredients in the product that may
cause problems to them.
Cruelty-Free Products (1)
! “Cruelty-free” or “Not tested on animals”
claims can often be found on labels or
advertisements.
! In the EU, testing of finished products and
ingredients on animals has already been
prohibited (it is referred to as the testing
ban).
Cruelty-Free Products (2)
! In the US, the FD&C Act does not specifically require
the use of animals in testing cosmetics for safety.
! The agency advises cosmetic manufacturers to
employ whatever testing is appropriate and effective
for substantiating the safety of their products.
! It remains the responsibility of the manufacturer to
substantiate the safety of both ingredients and finished
cosmetic products prior to marketing.
! Alternative methods to replace animal experiments,
such as ex vivo studies (i.e., studies using tissues from
an organism in an external artificial environment),
have been developed in the past decade.
Preservative-Free Products (1)
!Preservatives protect cosmetic
formulations from microbiological
contamination, for example, overgrowth
of molds, yeast and bacteria in lotions.
! As the majority of cosmetic formulations
c o n t a i n w a t e r, p r o t e c t i o n a g a i n s t
bacteria, molds, and yeast is essential.
Preservative-Free Products (2)
! A “preservative-free” claim is questionable most of
the time.
! We can rarely find products that have an
acceptable shelf life without any preservatives.
! Other product types that can claim to be
“preservative-free” include formulations containing a
higher percentage of ethanol, which is widely known
to have an antimicrobial activity.
! Certain products have a specific pH value that does
not favor the growth of microorganisms.
! There are also special types of packaging materials,
such as airtight packaging, which ensures the
absence of organisms.
Preservatives (1)
! Water-based cosmetic products provide a
perfect environment for microbial growth,
and the products’ additional components
can serve as nutrients for these
microorganisms.
! It should be kept in mind that a
contaminated product (which may show no
visible signs of contamination) is much more
dangerous for users than preservatives.
Preservatives (2)
! Itshould be noted that one of the most widely
and most frequently used preservatives are
called the parabens.
! These ingredients are very effective even in very
low concentration;
! they can cause allergic reactions in sensitive
consumers.
Preservatives (3)
! They were linked to breast cancer and
endocrine disruption. Although no study has
confirmed the potential risks of using parabens
on human health, the claims that they can
cause breast cancer and endocrine disruption
have been widely spread.
! As many consumers are afraid of using products
containing parabens, many formulators have
substituted parabens with other types of
preservatives to ensure product longevity.
!
Preservatives (4)
! They usually also claim their products to be
“paraben-free.” It does not mean that it does
not contain any sort of preservatives.
! There are a number of cosmetic ingredients
that have a primary effect, such as skin
conditioning, and have a limited antimicrobial
property as well. In such cases, the ingredient
added for its conditioning activity will also
prevent microbial contamination in the
product to a certain extent.
Preservatives (5)
! These types of preservatives are usually
called “non preservative preservatives” as
their primary function is not the prevention
of contamination. Their efficacy, however,
may be not as good as that of parabens;
formulations often have to use a higher
amount of these ingredients.
“Dermatologist Recommended "products
! The claim “dermatologist recommended” is
commonly used on cosmetic products.
! It may lead consumers to believe that a
medical panel of dermatologists has
evaluated the product quality and
recommends it based on proven results.
! The truth is that there is no governing body in
the US requiring cosmetic companies to show
data on whether a dermatologist, a few, or a
large number of them tested and recommend
a cosmetic product.
“Clinically Proven” Claims (1)
! The claim “clinically proven” is scientific
and powerful in the consumers’ mind. Since
claims made about cosmetic products must
be truthful and proven usually there is a
science behind such claims, and
companies perform tests to back up their
claims.
! It should be noted that clinical testing is not
required for cosmetic products that do not
have drug claims.
“Patented Formula” Claims
! Consumers believe that a product that has
been patented must be more serious and
scientific; it works better than other products.
! The truth is that patenting a product is often
related to the technology of how the product
is manufactured and not the actual effect of
the product.
! It does not necessarily mean that the product
is more effective or has a longer performance.
“pH Balanced” Claims
! Companies that make “pH balanced” claims try to
imply some level of superiority over products that
do not make this claim.
! They want consumers to believe that the products
will be less irritating and will work better.
! The product is formulated in a pH range that is
compatible with the skin, hair, underarms, or other
application surfaces.
! A consumer will never notice a difference between
a product that is “pH balanced” and one that is just
normally formulated.