Who are the experts?
To offer their industry expertise and deep market insight, CosmeticsDesign put your questions to two of our speakers:
- Dr. Maria Coronado, Euromonitor: ingredients analyst and doctor in chemical engineering. Find some of her recent insights here.
- Dr. Alain Khaiat, Seers Consulting: cosmetics consultant and contractor; an expert in the Asia region.
What are the regulatory considerations?
Are any of the panelists aware of any regulatory inquiries - either in US or EU - regarding pollution protection claims?
AK: I am not aware of any regulatory challenge anywhere in the World. Pollution is a real issue, definitely in the EU (and other countries having adopted the EU definition of cosmetics) "protection" of the skin to prevent damages is a cosmetic claim.
Is the use of the word 'protects' for an anti-pollution product a signal to the FDA for a Drug type claim like sunscreen?
MC: Currently, anti-pollution products are considered as cosmetics and there are two main reasons: (1) The first one is that the ingredients that are normally used are either natural ingredients such as plant extracts or film forming polymers, (2) the second one is that the anti-pollution claims are cosmetic claims rather than drug claims.
I am not an expert on regulatory issues but if you ask for my opinion, I would say that the word “protect” itself or “provides protection against pollution damage” does not necessarily imply that the product needs to be considered as a drug.
Sunscreens fall under the definition of drug in the Federal Food, Drug, and Cosmetic Act because they contain active sunscreen ingredients, they are intended to prevent sunburn and protect the skin from the harms of solar radiation and they affect the body’s physiological response to radiation in that they lessen its erythema reaction. Antipollution ingredients, however, are usually antioxidants (plant extracts and vitamins) and film forming polymers which are not claiming to modify the skin structure or function.
Antioxidants are used in cosmetic products to protect the skin from oxidative stress and polymers are used in cosmetics to create a barrier film that protects the skin from wetness (water resistance) or that protects the skin’s moisture barrier, and they are not considered as drugs.
Anti-pollution ingredients could fall into the definition of drugs requiring FDA approval if:
- They have a well-known drug activity, which means that the mechanisms of protection are based on modifying the organic structure or the function of the skin, it would be no longer considered as a cosmetic and would be considered as a drug.
- If an anti-pollution cosmetic product claims to treat or prevent skin diseases such as acne or psoriasis caused by pollution then, it would be no longer considered as a cosmetic and would be considered as a drug.
I don’t believe this is going to happen.