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Is it a Cosmetic or a Drug?

New Products Questions and Answers

So you made something super special and it gets rid of those pesky brown circles under your eyes! How can you market to your customers and let them know just how great it works? The FDA is pretty clear on this. If you want to tell your customers it will remove dark circles under their eyes that is it no longer a cosmetic it is now a drug. You are treating a condition with it. So what can you say? In in your description you can say something like “caffeine has been used for centuries to reduce circles under your eyes” or you can name your product “no more circles” but you can not say it will do anything for the circles around your eyes.

What if you are so convinced you have a product that will do everything you think it does and what to say just that? You then need to take you product to a lab which tests for efficacy (the ability to produce a desired or intended result) and the results much show it works.

There is a fine line here so think carefully before you launch a product that is meant for treatment rather than cosmetic use.

Here is an excerpt from the FDA site:

How is a product’s intended use established?

Intended use may be established in a number of ways. The following are some examples:

  • Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.
  • Consumer perception, which may be established through the product’s reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
  • Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for “essential oils.” For example, a fragrance marketed for promoting attractiveness is a cosmetic. But a fragrance marketed with certain “aromatherapy” claims, such as assertions that the scent will help the consumer sleep or quit smoking, meets the definition of a drug because of its intended use. Similarly, a massage oil that is simply intended to lubricate the skin and impart fragrance is a cosmetic, but if the product is intended for a therapeutic use, such as relieving muscle pain, it’s a drug.”




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