What is a claim?
Claims include all images, texts or symbols used by brands to present the characteristics of cosmetic products. They are a key component of marketing, especially product labeling, and have a crucial role in making customers prefer your products from others. Claims will appear on the label but also in ads, magazines, websites, etc.
What are claims used for?
- Describe the effects of a product
- Help consumers/users choose a product
- Make the product seem more appealing than the competition
Some examples of claims used in the cosmetic industry:
- Help reduce the appearance of wrinkles
- Moisturizes/Nourishes skin
- Cleans skin, etc.
You must be aware that in the U.S., all communication about a cosmetic product is considered as a claim, including a website, advertisements, social media, etc. You should monitor closely what your partners are saying about your products.
How are cosmetic claims regulated?
Cosmetic labeling does not require FDA (Food and Drug Administration) approval before products go on the market, but products are monitored once in the market. Hence, cosmetic firms must follow some rules: claims have to be honest, truthful, sufficiently substantiated and appropriate for cosmetic products.
Here are some examples of claims that are not allowed on cosmetic products:
- Indicate that the product treats or prevents disease (cure cancer, treat acne, etc.)
- Mention any medical condition (including skin conditions such as acne, eczema, etc.)
- Indicate that the product affects the structure or function of the body and skin (regenerate cells, stimulate collagen production, remove cellulite, skin whitening, wrinkle removal etc.)
One of the most common mistakes concerning claims, is the use of unapproved drug claims on cosmetic products. Unlike cosmetic claims, drug claims have to be approved by the FDA before it goes on the market. If the FDA considers a product being marketed with �drug� claims, it can issue warning letters asking the company to remove the drug claims from the labeling or to seek FDA approval to market the products as drugs.
Cosmetic and drug claims: how to make the difference?
You should always bear in mind the product�s intended use, as it is what makes the difference between a cosmetic or a drug product in the United States.
What is the purpose of your product?
- To cleanse, beautify, promote attractiveness or alter the appearance? It�s a cosmetic product.
- To cure, treat or prevent disease? It�s a drug.
Good to know: If a product is marketed with claims such as treating or preventing disease, or affecting the structure or function of the body�including the skin�it�s considered as a drug, even if it affects the appearance.
Also, if the public or the industry thinks of your product as being able to treat a disease or to have a therapeutic use, even if you don�t use drug claims, your product will be considered as a drug. An example is fluoride in toothpaste.
Now that you better understand the difference between a cosmetic product and a drug, make sure your cosmetic claims always reflect the purpose of a cosmetic product and not a drug.
How to substantiate your cosmetic products?
Substantiation is about proving that the claims used to prove your products are truthful and not misleading. Even if cosmetics claims substantiation is not clearly indicated as required in the U.S. regulation, backing up your products� claims with proofs is the most reasonable thing to do. It will help consumers make informed choices, and it will improve your brand�s image.
The three main methods to substantiate your cosmetics claims are:
- Gathering evidence via consumer perception tests and questionnaires
- Using information from scientific publications and market data
- Experimental studies (in silico, in vitro, ex vivo, in vitro, etc.)
EcoMundo guides you through the whole process
One of the key steps when developing a new product is making sure that the �intended use� matches the definition of a cosmetic product. Our regulatory experts can help you in this tricky assessment to make sure your products are in the right category and that the claims used on your products are cosmetic claims and not drug claims. They can also help you substantiate your claims.
> Review your cosmetic products with EcoMundo�s experts
Wish to know more about the regulation of cosmetic products in the U.S.?
For more information, do not hesitate to contact Emmanuel Fritsch.
What is a claim?
Claims include all images, texts or symbols used by brands to present the characteristics of cosmetic products. They are a key component of marketing, especially product labeling, and have a crucial role in making customers prefer your products from others. Claims will appear on the label but also in ads, magazines, websites, etc.
What are claims used for?
- Describe the effects of a product
- Help consumers/users choose a product
- Make the product seem more appealing than the competition
Some examples of claims used in the cosmetic industry:
- Help reduce the appearance of wrinkles
- Moisturizes/Nourishes skin
- Cleans skin, etc.
You must be aware that in the U.S., all communication about a cosmetic product is considered as a claim, including a website, advertisements, social media, etc. You should monitor closely what your partners are saying about your products.
How are cosmetic claims regulated?
Cosmetic labeling does not require FDA (Food and Drug Administration) approval before products go on the market, but products are monitored once in the market. Hence, cosmetic firms must follow some rules: claims have to be honest, truthful, sufficiently substantiated and appropriate for cosmetic products.
Here are some examples of claims that are not allowed on cosmetic products:
- Indicate that the product treats or prevents disease (cure cancer, treat acne, etc.)
- Mention any medical condition (including skin conditions such as acne, eczema, etc.)
- Indicate that the product affects the structure or function of the body and skin (regenerate cells, stimulate collagen production, remove cellulite, skin whitening, wrinkle removal etc.)
One of the most common mistakes concerning claims, is the use of unapproved drug claims on cosmetic products. Unlike cosmetic claims, drug claims have to be approved by the FDA before it goes on the market. If the FDA considers a product being marketed with �drug� claims, it can issue warning letters asking the company to remove the drug claims from the labeling or to seek FDA approval to market the products as drugs.
Cosmetic and drug claims: how to make the difference?
You should always bear in mind the product�s intended use, as it is what makes the difference between a cosmetic or a drug product in the United States.
What is the purpose of your product?
- To cleanse, beautify, promote attractiveness or alter the appearance? It�s a cosmetic product.
- To cure, treat or prevent disease? It�s a drug.
Good to know: If a product is marketed with claims such as treating or preventing disease, or affecting the structure or function of the body�including the skin�it�s considered as a drug, even if it affects the appearance.
Also, if the public or the industry thinks of your product as being able to treat a disease or to have a therapeutic use, even if you don�t use drug claims, your product will be considered as a drug. An example is fluoride in toothpaste.
Now that you better understand the difference between a cosmetic product and a drug, make sure your cosmetic claims always reflect the purpose of a cosmetic product and not a drug.
How to substantiate your cosmetic products?
Substantiation is about proving that the claims used to prove your products are truthful and not misleading. Even if cosmetics claims substantiation is not clearly indicated as required in the U.S. regulation, backing up your products� claims with proofs is the most reasonable thing to do. It will help consumers make informed choices, and it will improve your brand�s image.
The three main methods to substantiate your cosmetics claims are:
- Gathering evidence via consumer perception tests and questionnaires
- Using information from scientific publications and market data
- Experimental studies (in silico, in vitro, ex vivo, in vitro, etc.)
EcoMundo guides you through the whole process
One of the key steps when developing a new product is making sure that the �intended use� matches the definition of a cosmetic product. Our regulatory experts can help you in this tricky assessment to make sure your products are in the right category and that the claims used on your products are cosmetic claims and not drug claims. They can also help you substantiate your claims.
> Review your cosmetic products with EcoMundo�s experts
Wish to know more about the regulation of cosmetic products in the U.S.?
For more information, do not hesitate to contact Emmanuel Fritsch.
