Paolo Giacomoni, PhD, Insight Analysis Consulting03.21.23
Concerned citizens are sometimes uncertain about the goals of the law. Should the law prohibit what is unacceptable for a majority of citizens? Or should the law foster changes so that the society undergoes healthy evolution? When it comes to personal care, there is a consensus, first, that products should not harm, and second, that they should have favorable effects when administered. The consensus seems to vanish when we deal with the advertising of these products. And because of the creativity of the human being, regulatory agencies find themselves often in uncharted waters.
The finished formula was advertised with something like “This product puts the internal clocks of your skin back in register.” With a pinch of Albionic humor, a British regulatory agency asked: “What if my skin’s clocks are already in register?”—and forbade that line of advertisement.
In other words, the Italian regulatory agency recommended to advertise the new ingredient as a stable antioxidant, that is the most oxymoronic concept that one can encounter in elementary chemistry.
In the following years, Lancôme launched Primordial, a vitamin E-containing product. I had worked on the efficacy of vitamin E with cultured cells and with human volunteers, and I had published nine papers in peer-reviewed international scientific journals. In these papers, I did show that the application of vitamin E after exposure to UV radiation hindered or removed cell and tissue damage. Since aging is accumulation of damage, I concluded that vitamin E is an anti-aging factor. When I came to the US to advertise Primordial, I was told by the then head of L’Oréal USA to change my presentation.
He told me: “According to what you say, vitamin E is a drug. As such, the FDA will prohibit its use in cosmetics.”
And since I was trying to defend my presentation, he added: “You don’t understand, if you show that water has any type of biochemical action, the FDA will say that it is a drug and will forbid its use in skin care products.”
In the US, UV filters were once displayed in a “positive” list, meaning that the 15 to 20 molecules in that list were the only molecules that could be used to manufacture sunscreens. In recent years, because the safety data of many of these filters are considered to be insufficient, the positive list shrank to two filters: zinc oxide and titanium dioxide. Fine but, are we sure they are safe? It so happens that ZnO and Ti2O, when exposed to ultraviolet radiation, are potent generators of singlet oxygen, a very reactive form of oxygen… and yet, the FDA does not mention any recommendation so that singlet oxygen will not be generated by those two filters when they are applied on the skin.
My point is the following. The quantum yield for the generation of singlet oxygen by ZnO or Ti2O has been reported to be ~0.3. This means that one out of three absorbed UV photons has its energy transferred to molecular oxygen to form singlet oxygen. We know that one molecule of singlet oxygen has the capability of starting a peroxidative cascade of thousands of steps, provoking the peroxidation of lipids in membranes and the carbonylation of proteins in the cytoskeleton, leading to cell death, tissue necrosis, inflammation, accelerated aging and perhaps even worse endpoints. And the FDA is audibly silent.
But that is not the worst of it.
In the US, anti-acne claim “transforms” a skin care product into a drug that can be purchased without prescription and has to be manufactured according to rigorous guidelines. Fine. The grotesque point in this is that there is no legal obligation to provide experimental evidence to claim that the product is “anti-acne.” For the claim to be allowed it is only necessary for the product to contain a defined amount of salicylic acid or of some other specified ingredient.
Can we live with this? Far from the accepted principle: “First, do not harm,” I see two victims in this behavior of the regulatory agencies.
The first victim is the well-being of the skin of the consumer. It can be treated without any kind of success, or even harmed, by legally marketed and advertised products.
The second victim is the brain of the consumer. He or she is invited to believe in stable antioxidants, in efficacy without proof, and in any other kind of creative fake news.
Paolo Giacomoni, PhD
Insight Analysis Consulting
[email protected]
516-769-6904
Paolo Giacomoni acts as an independent consultant to the skin care industry. He served as Executive Director of Research at Estée Lauder and was Head of the Department of Biology with L’Oréal. He has built a record of achievements through research on DNA damage and metabolic impairment induced by UV radiation as well as on the positive effects of vitamins and antioxidants. He has authored more than 100 peer-reviewed publications and has more than 20 patents. He is presently Head of R&D with L.RAPHAEL—The science of beauty—Geneva, Switzerland.
The Good
Years ago, an executive of a major marketing-driven company learned about biorhythms and chronobiology. She asked R&D to find ingredients active in this field. R&D complied, undertook cell-culture experiments and provided an appropriate ingredient.The finished formula was advertised with something like “This product puts the internal clocks of your skin back in register.” With a pinch of Albionic humor, a British regulatory agency asked: “What if my skin’s clocks are already in register?”—and forbade that line of advertisement.
The Bad
L’Oréal is a technology-driven company. In the 1990s, discussions about the opportunity of using antioxidants in skin care lasted several years. Researchers analyzed in depth the chemistry and the biochemistry of antioxidants. When it was decided to go with antioxidants, R&D came up at first with a derivative of vitamin C that was stable and had a long shelf life. This derivative was converted into ascorbic acid upon topical application, by the action of stratum corneum esterases and phosphatases. The Lancôme product containing this precursor of vitamin C was advertised as R&D had explained. An Italian regulatory agency wrote a letter to the CEO of L’Oréal that I was asked to translate, because it was written in Italian. In this letter, it was clearly recommended that imaginative advertising be left to small cosmetic companies, that are allowed more tolerance in creative advertising, whereas “…a serious company such as L’Oréal should not indulge in such fantastic advertising because people could believe it.” Therefore, the Italian agency demanded the company withdraw the advertising.In other words, the Italian regulatory agency recommended to advertise the new ingredient as a stable antioxidant, that is the most oxymoronic concept that one can encounter in elementary chemistry.
In the following years, Lancôme launched Primordial, a vitamin E-containing product. I had worked on the efficacy of vitamin E with cultured cells and with human volunteers, and I had published nine papers in peer-reviewed international scientific journals. In these papers, I did show that the application of vitamin E after exposure to UV radiation hindered or removed cell and tissue damage. Since aging is accumulation of damage, I concluded that vitamin E is an anti-aging factor. When I came to the US to advertise Primordial, I was told by the then head of L’Oréal USA to change my presentation.
He told me: “According to what you say, vitamin E is a drug. As such, the FDA will prohibit its use in cosmetics.”
And since I was trying to defend my presentation, he added: “You don’t understand, if you show that water has any type of biochemical action, the FDA will say that it is a drug and will forbid its use in skin care products.”
The Ugly
In the US, sunscreens are considered drugs. This has the advantage of being crystal clear. Sunscreens can be sold without prescription, but they must be manufactured according to rigorous guidelines; they must provide evidence of efficacy according to rigorously described experimental protocols, and they must satisfy strict criteria of safety, both for the “patients” as well as for the environment.In the US, UV filters were once displayed in a “positive” list, meaning that the 15 to 20 molecules in that list were the only molecules that could be used to manufacture sunscreens. In recent years, because the safety data of many of these filters are considered to be insufficient, the positive list shrank to two filters: zinc oxide and titanium dioxide. Fine but, are we sure they are safe? It so happens that ZnO and Ti2O, when exposed to ultraviolet radiation, are potent generators of singlet oxygen, a very reactive form of oxygen… and yet, the FDA does not mention any recommendation so that singlet oxygen will not be generated by those two filters when they are applied on the skin.
My point is the following. The quantum yield for the generation of singlet oxygen by ZnO or Ti2O has been reported to be ~0.3. This means that one out of three absorbed UV photons has its energy transferred to molecular oxygen to form singlet oxygen. We know that one molecule of singlet oxygen has the capability of starting a peroxidative cascade of thousands of steps, provoking the peroxidation of lipids in membranes and the carbonylation of proteins in the cytoskeleton, leading to cell death, tissue necrosis, inflammation, accelerated aging and perhaps even worse endpoints. And the FDA is audibly silent.
Conclusion
From the example above, it appears that regulatory agencies, even in technologically advanced countries, can behave as obscurantists insofar as they can foster false advertising and can sometimes promote potentially unsafe ingredients.But that is not the worst of it.
In the US, anti-acne claim “transforms” a skin care product into a drug that can be purchased without prescription and has to be manufactured according to rigorous guidelines. Fine. The grotesque point in this is that there is no legal obligation to provide experimental evidence to claim that the product is “anti-acne.” For the claim to be allowed it is only necessary for the product to contain a defined amount of salicylic acid or of some other specified ingredient.
Can we live with this? Far from the accepted principle: “First, do not harm,” I see two victims in this behavior of the regulatory agencies.
The first victim is the well-being of the skin of the consumer. It can be treated without any kind of success, or even harmed, by legally marketed and advertised products.
The second victim is the brain of the consumer. He or she is invited to believe in stable antioxidants, in efficacy without proof, and in any other kind of creative fake news.
Paolo Giacomoni, PhD
Insight Analysis Consulting
[email protected]
516-769-6904
Paolo Giacomoni acts as an independent consultant to the skin care industry. He served as Executive Director of Research at Estée Lauder and was Head of the Department of Biology with L’Oréal. He has built a record of achievements through research on DNA damage and metabolic impairment induced by UV radiation as well as on the positive effects of vitamins and antioxidants. He has authored more than 100 peer-reviewed publications and has more than 20 patents. He is presently Head of R&D with L.RAPHAEL—The science of beauty—Geneva, Switzerland.