Dr. Levine: There is a lot of
misinformation out there about so-called cosmeceuticals, what they can do for
our patients and how we should promote them. Can you explain what is a
cosmeceutical, how is it different from a drug and how is it different from a
cosmetic?
Dr. Draelos: Actually there is no such
thing as a cosmeceutical. The FDA (Food and Drug Administration) does not
recognize this term. The term cosmeceutical, in their eyes, is another word for
cosmetics. I think if you ask the dermatologists what is a cosmeceutical, they
would tell you that it’s a product that enhances the skin in some manner,
different from a cosmetic that traditionally is thought to only scent, color,
and adorn the skin, but there is no such thing as cosmeceutical from a
regulatory standpoint.
There are three categories: there are prescription
drugs; there are over-the-counter (OTC) drugs, which include such things as
sunscreen, antiperspirants, and toothpaste; and then there are cosmetics.
Cosmetics are a category that is currently unregulated. The over-the-counter
drugs are regulated through a monograph and we are all familiar with how the FDA
regulates pharmaceuticals.
Cosmeceuticals is a relatively new category. It’s a
contraction of the word cosmetic and pharmaceutical that was coined by Dr.
Albert Kligman. There are countries around the world where cosmeceuticals are
recognized, such as Japan. In Japan they call cosmeceuticals quasi-drugs.
Cosmeceuticals are basically substances that perhaps might alter the skin, but
the marketing claims that are used are identical to cosmetics and all
ingredients that are used in cosmeceuticals must be considered GRAS (Generally
Recognized As Safe) ingredients.
Dr. Levine: So by definition if these
are cosmetics, my understanding is therefore they can have no medicinal
value?
Dr. Draelos: Exactly. If you look at
the claims that are made for the efficacy of cosmeceuticals, they are all
appearance claims. A drug claim would be “gets rid of wrinkles;” a cosmeceutical
or cosmetic claim would be “improves the appearance of wrinkles.” As you are
reading packaging and trying to decide exactly what this particular formulation
does, you will notice that it says “improves the appearance of fine lines,”
“improves the appearance of pores,” “improves the appearance of facial redness,”
“smoothes the skin,” “makes skin more radiant,” “makes skin more luminous.”
Those are all referring to appearance changes that could be induced by the
product when it’s applied to the skin.
Dr. Levine: So does that mean that we
as dermatologists have some obligation not to differentiate cosmeceuticals from
cosmetics, or can we go beyond what FDA is interpreting as cosmetic?
Dr. Draelos: I think we can go little
bit beyond the FDA, because we are actually seeing the entry into dermatology of
many substances that actually are cosmetic drugs. One of the first ones was
approved by the FDA this year for a product that reduces facial redness. It is
temporary, like a cosmetic. It reduces facial redness for several hours
depending on the individual. It is given to the patient in a form of a
prescription. It is purchased at the pharmacy, but instead of “curing or
altering the disease process,” it simply improves the appearance of facial
redness.
We are starting to see in dermatology the entry of
substances that improve appearance but are truly drugs, which is one end of the
spectrum of cosmeceuticals. And then we also see products that are entering the
marketplace, for example, things that are called line blurs or wrinkle reducers,
and those are products that are also temporary, but they are purchased
over-the-counter and they contain silicone. The silicone base fills in the
undulations of the skin surface where the wrinkles are present, and by filling
those in, (it) improves skin smoothness and diminishes the appearance of
wrinkles. So it’s interesting that we have — in two very different categories —
products to achieve the same thing, which is a temporary improvement in
appearance.
Dr. Levine: So what do we as
dermatologists do to find out which ones have some value and which ones do
not?
Dr. Draelos: There is actually a lot
of testing that goes into cosmeceutical development. Companies test
cosmeceuticals looking for an immediate benefit: that’s the smoothness and the
softness, because when a consumer purchases a product, she wants to see
something immediate, which is something that pharmaceuticals traditionally do
not deliver.
We usually tell a patient — for example, when they are
using a topical rosacea medication — that one will need to use this product for
four to six weeks before one will see a reduction in papules and pustules. But
in the cosmeceuticals realm, people want to see immediate improvement. That’s
where the moisturizer comes in that makes the skin smooth and soft.
Then there are botanical anti-inflammatories that could
be added into a cosmeceutical formulation that indeed over time might reduce
redness, not perhaps to the degree that a pharmaceutical would, but it still has
some beneficial effect. Most companies are looking for significant market share
with their products and will build in short-term benefits and long-term
benefits. The long-term benefits will not be to the level of a pharmaceutical,
but still they are consumer perceivable benefits, which might result in some
redness reduction because of a botanical anti-inflammatory, such as bisabolol,
which is a chamomile extract with an anti-inflammatory topical effect.
Dr. Levine: Of all these hundreds of
agents, can you pick out a few that you really think have value over and above
the others?
Dr. Draelos: Probably the most
important one is sunscreen. Because the new sunscreen guidelines allow companies
to make anti-aging claims based on the inclusion of sunscreen, we are going to
see an increase in anti-aging claims because of sunscreen inclusion. The idea is
that sunscreens prevent DNA damage, and when you prevent DNA damage, you prevent
aging.
If a product contains a sunscreen, technically it does
become an over-the-counter drug, but not only can SPF designations be placed on
a label, companies can now make an anti-aging claim. You are going to see a
whole new cadre of cosmeceuticals that have anti-aging claims, that may also
contain sunscreen and mushroom extracts, but the sunscreen is the workhorse
that’s providing the anti-aging benefit and the mushroom extract is along just
for the ride. The product will say that it reduces the appearance of wrinkles
substantiated by sunscreen inclusion, and then it will say contains mushroom
extract.
When you make a claim that says “contains something,”
that is basically a disclosure of the ingredient on the front of the package.
They are not saying the mushroom extract does anything. But if you tell the
consumer “this reduces the appearance of wrinkles and it contains mushroom
extract,” sometimes the consumer will think mushroom extract is reducing the
wrinkles, not the inclusion of sunscreen. This is an interesting area.
The second interesting area of ingredients is the
introduction of retinol into products. Retinol, as you remember, is the vitamin
version of vitamin A. It is a precursor to retinoic acid, which we know of as
tretinoin. Retinol is actually a precursor of tretinoin and since tretinoin has
anti-aging benefits, so does retinol. There are some studies that show that
somewhere between 1 and 2 percent retinol can indeed improve the appearance of
the skin by working through the retinoid receptor.
The third category to watch would be the
anti-inflammatories. Now many of the new cosmetics that reduce redness and
facial irritation actually contain 0.5 percent hydrocortisone, which makes them
an over-the-counter drug. So it’s interesting that cosmetic formulations are
tapping into OTC drugs to deliver some of their claims, but there are some
licorice extracts such as Licochalcone A. There are some camomile extracts like
I mentioned earlier such as bisabolol. There are also other plant sterols that
are being used as anti-inflammatory agents and so anti-inflammatories is another
category.
Certainly these are not anti-inflammatory agents that
will reduce disease, such as facial dermatitis, but they might reduce redness
and they might reduce some of the itching and stinging. Many of those
ingredients like bisabolol are used in sensitive skin formulations and the idea
is to include an anti-inflammatory that will allow people with sensitive skin to
be able to wear those products.
Dr. Levine: Could you comment on the
current rage about the use of the word “natural” in many of these products. What
does that mean and is that important?
Dr. Draelos: The FDA actually has
become very concerned about use of the word natural, because natural actually
has no meaning whatsoever. “Natural” became a concern in food products because
people were thinking that natural might somehow mean that these products didn’t
contain any chemicals, they didn’t contain preservatives. In the cosmetics
industry, people wanted to put “natural” on their products to imply that there
weren’t any chemicals that were toxic, irritating, or might induce some other
type of damage, such as the generation of reactive oxygen species.
Everything that is found on the earth is natural to
this earth, whether it will be a pesticide or preservative or a celery extract,
but not all those substances are beneficial to the skin. For example, celery
extract actually contains a carcinogen and that is an area of controversy where
many plants, in order to protect themselves from overgrazing by animals, will
contain toxins. Those toxins will poison the animal so to speak if it overeats
that particular product and that’s how the plant materials sustain themselves on
the earth. There are many natural ingredients that could find their way into
cosmetics that are not good for the skin.
For example, feverfew, which is an ingredient that is
found in a number of facial products, actually has an allergen called
parthenolide, The parthenolide had to be removed from the feverfew before it
could be put in cosmetics. So, not everything that comes from plants is good for
the skin. They are all natural, but natural is perhaps one of those words that
doesn’t have a lot of scientific meaning, just like the word radiance. You will
see a lot of topical cosmeceuticals say they improve skin radiance. Well, what
is radiance? No one really knows. We think that it’s increased light reflection
from the skin surface which is truly an optical effect, not implying any change
in the skin itself, but if you tell someone you look natural and radiant,
somehow those words have a connotation that make people feel they have an
improved appearance.
Dr. Levine: Is there a way that we and
consumers can sort out which manufacturers are reliable and which may not be
reputable?
Dr. Draelos: Sorting out quality
products can be difficult, but many cosmetic companies are now publishing the
results of their research and those results are being published in dermatology
journals, such as the one I edit which is the Journal of Cosmetic
Dermatology. If you Google a new ingredient, you should be able to pull up
some articles that actually substantiate the value of that ingredient. So
looking in the dermatology literature for supportive articles can be
helpful.
You will also see many companies that will put their
data with their packaging. For example, their data will say “dermatologist
tested,” and this is complemented by a bar graph that demonstrates efficacy. All
cosmetic companies do some type of safety testing on their products, which is
the Repeat Insult Patch Test (RIPT). This is done by the company or it could be
done by the raw material supplier that provides the ingredients to the
company.
Repeat Insult Patch Testing is where the product is
applied to the back of volunteers to better understand if irritant contact
dermatitis or allergic contact dermatitis might occur. RIPT testing is usually
done not only on the raw materials that are put into the product, but also done
on the final formulation. This type of testing is done routinely to prevent the
introduction of products into the marketplace that could result in safety
issues.
The second type of testing that is done is efficacy
testing. Most of the large companies will do efficacy testing to prevent
themselves from getting sued by the Federal Trade Commission over making false
or misleading advertising claims. They will also do efficacy testing to prevent
competitors from suing them and stating that they made false claims. So there
are claims such as “dermatologist tested,” that now mean that some dermatologist
who is board-certified in dermatology tested that product.
DermatologyTimes 2/2014
