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Is it ok to use the name eczema in our product and also write this is not a drug?
What if we use the name eczema or Acne in our product and at the bottom write a note that this is not a drug or this is not Intended to cure any disease. Would it be legal?
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6 Replies
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Why would you be putting the name of a skin condition (ie: disease) as part of the name of your product if not with intent to deceive consumers?
Reminds me … I need to dust that formula for Covid Cola off the shelf!
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MarkBroussard said:Why would you be putting the name of a skin condition (ie: disease) as part of the name of your product if not with intent to deceive consumers?Reminds me … I need to dust that formula for Covid Cola off the shelf!
Because my product actually works for that skin condition (eczema) but as a startup company i don’t want the complications of being a drug manufacturer.
It is the same reason as Paula’s choice that doesn’t claim acne treatment with %2 salicylic acid liquid at pH 3.5 but another company claim’s that in a soap with %2 salicylic acid at whatever pH that soap is.
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I understand your motivation, but the regulations are clear in this regard. If your product is not an OTC, then you can’t use the dissease name associated with your product in any way. Some companies take the chance hoping that the FDA will not become aware of the violation and fly under the radar until they get a violation notice.
The DermaHarmony product you are referencing above is indeed an OTC-registered product. They list Active Ingredient: 2% Salicylic Acid, so they are in compliance.
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MarkBroussard said:@Abdullah
I understand your motivation, but the regulations are clear in this regard. If your product is not an OTC, then you can’t use the dissease name associated with your product in any way. Some companies take the chance hoping that the FDA will not become aware of the violation and fly under the radar until they get a violation notice.
The DermaHarmony product you are referencing above is indeed an OTC-registered product. They list Active Ingredient: 2% Salicylic Acid, so they are in compliance.
I got the point.
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As an example: Eucerin in the EU can sell a product called ‘AtopiControl’ which is derived from and resembles the word ‘atopic dermatitis’, a condition for which this line has been designed. However, in Switzerland, that name is already too close to a disease’s name and hence, the name had to be truncated to ‘AtoControl’.Mind, that product range isn’t intended as drugs to treat atopic dermatitis but as supplemental care for that and related skin conditions. Depending on regulations/country, this alone is already a tabu for cosmetics. -
Pharma said:As an example: Eucerin in the EU can sell a product called ‘AtopiControl’ which is derived from and resembles the word ‘atopic dermatitis’, a condition for which this line has been designed. However, in Switzerland, that name is already too close to a disease’s name and hence, the name had to be truncated to ‘AtoControl’.Mind, that product range isn’t intended as drugs to treat atopic dermatitis but as supplemental care for that and related skin conditions. Depending on regulations/country, this alone is already a tabu for cosmetics.
Thanks
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