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.