Labellng Products and Cosmetics to Achieve FDA Approval

What is the difference between a cosmetic and a drug?

How exactly are these two categories classed?

In America, in order to meet strict FDA approval, specific guidelines have been set.

So personal care products can be put into specific categories.


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!


If I was considering introducing a new skin care range, to treat the skin condition Acne, a range that contains antiseptic ingredients, that specifically targets bacteria in the follicle wall.

Unless I get the product registered as an over the counter drug, I would not be allowed to make the claim that it kills bacteria.

All I would be allowed to claim, is that the product helps with the appearance of the skin.

I am 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 I formulate a product for ageing skin, one that contains powerful Antioxidants and Alpha Hydroxy Acids, a product that actively encourages cellular renewal, and I 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 I am allowed to claim is that the skin will appear healthy and glowing, and that the skin’s texture would be improved.

I am only allowed to discuss the appearance of the skin.

As a final example, if I’m creating an Anti Ageing formula, one that reduces the appearance of fine lines and forehead wrinkles.

Providing I’m not implying that the product physically reduces or eliminates fine lines or wrinkles, then I fall within the legal frame work.

This is why on packaging of skin care 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 America, if a skin care manufacturer were to 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 could 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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