Labellng Products and Cosmetics to Achieve FDA Approval

What is the difference between a cosmetic and a drug? And how exactly are these two categories classed?

In the USA in order to meet strict FDA approval, guidelines have been set, so personal care products can be put into specific categories.

Sticking with our transparency around skincare and formulas, let’s dive a little deeper and look at labelling requirements in the USA.

Labelling and FDA approval

This Act defines cosmetics as the following:


Articles other than food, that are intended to affect the structure or any function of the body.


Articles intended to be rubbed, poured, sprinkled or otherwise applied to the body. For cleansing, beautifying, promoting attractiveness or altering one’s appearance.

The law states, “Anyone who creates a product that falls under the umbrella of cosmetics, are not allowed to make claims that their product will affect the physiological function of the skin”.

Essentially what this means, is that if a product is being sold for retail purposes…

In order to achieve FDA approval, the label is only allowed to state that it improves the appearance of the skin and nothing beyond that!

How your skincare products are labelled

If at the Naked Chemist we were considering introducing a new skincare range to treat the skin condition Acne, a range that contains Astringent, Antimicrobial ingredients that specifically target bacteria in the follicle wall unless we get the product registered as an over the counter drug, we would not be allowed to make the claim that it kills bacteria, all we would be allowed to claim is that the product helps with the appearance of the skin.

We are allowed to discuss the products ability to reduce large pores and remove excess oil off the skin because this is only making claims about the skin’s appearance.

Or if we create a product for mature, ageing skin, one that contains powerful Antioxidants and Alpha Hydroxy Acids, a formula that actively encourages cellular renewal, and we wanted to make a specific claim about how the formula affects the body.

For example:

  • Antioxidants make skin cells healthy and reduce premature ageing
  • Alpha hydroxy acid, helps to increase collagen production

The product would then automatically become a drug. In reality, all that we are allowed to claim is that the skin will appear healthy and glowing and that the skin’s texture would be improved, as we are only allowed to discuss the appearance of the skin.

As a final example, if we are creating an anti-ageing formula, one that reduces the appearance of fine lines and forehead wrinkles, providing we are not implying that the product physically reduces or eliminates fine lines or wrinkles, then we fall within the legal framework.

This is why on the packaging of skincare products, you will only find keywords that suggest the skin looks better;

  • Helps to
  • Assists in
  • Improves the appearance of
  • Reduces the appearance of
  • Diminishes visible signs of

In the USA, if a skincare manufacturer is o be found to be making untrue claims they won’t get FDA approval, in fact, any company found to be making false claims, would be seriously reprimanded by the FDA if they feel a company is breaking the law, they have the right to investigate the business which can possibly result in a costly lawsuit.

2 thoughts on “Labellng Products and Cosmetics to Achieve FDA Approval

  1. Judith says:

    I am currently looking to create my own skincare line. I no longer have the time to formulate my products and are seeking new formulations, packaging, and unique glass bottling.

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