Article by: Perry Romanowski

Contrary to what you read on the Internet, the cosmetics industry in the US is regulated.  It is regulated by the FDA and they do a fairly decent job of it given their limited resources.  Cosmetics are some of the most safe consumer products you can buy.  One of the biggest mistakes companies make is that they “accidentally” turn their cosmetic products into drugs.  When this happens the FDA will contact you and if you don’t change your ways, they will impound or confiscate your products. cosmetics and drugs

Here is how you can turn your cosmetic into a drug and how to avoid doing that.

Use a drug active

In the US, an ingredient that interacts with living tissue and causes the cells to behave in a way that they normally wouldn’t is considered a drug.  The FDA lists a number of drug actives and these can not normally be used in cosmetic products.  So if you include an anti-dandruff ingredient or a glaucoma drug active in your formula you are selling a misbranded drug.  Even if you don’t make claims that the drug is doing anything for people you are still inappropriately selling a drug.  You might be able to hide from the FDA for a little while like this company did but eventually they will find you, warn you, confiscate your product and likely shut down your production.

Don’t secretly use drug actives in your cosmetics!

Make a drug claim

Most cosmetic companies don’t use drug actives, but they make the more common mistake of making drug claims which turn their cosmetic into a misbranded drug.  Raw material suppliers will often come to you with claims about ingredients that can stimulate collagen production, boost hair growth, or do some other magical transformation to the body.  Your suppliers can say these things but you can’t.  At least you can’t do it in a direct way.  Any claim that suggests your product is interacting or interfering with normal body metabolism is a drug claim and the FDA can send you a warning letter and potential shut you down.

Here is a recent example.  The company Cell Vitals was warned by the FDA for making drug claims about their cosmetic product.  Here are some of their offenses.

The company claimed that their stem cell facial moisturizer contained Camellia Sinesis Extract which is “anti-bacterial and … anti-cancer.”  They also said that their product contains “Argireline® …keeps down the release of a neural signal protein (catecholamine) and thus, prevents the muscle contraction involved in facial expressions.”

Those are not cosmetic claims!  And they will get you in trouble with the FDA if you make them.

Note the FDA has people that scour the Internet specifically looking for companies that are making illegal drug claims.  Being small is no guarantee that you can get away with it.

Avoiding problems

To avoid the problem of turning your cosmetic into a drug follow these tips.

1.  Don’t claim that your product will treat a disease.
2.  Don’t claim your product changes the body’s biochemistry
3.  Use phrases like “changes the appearance” or “helps the body” or “stimulates”
4.  Don’t ascribe function to any single ingredient.  Always say your formula provides the benefits.

If you follow these tips you should be ok but you’ll see some competitor’s who continue to make drug claims.  Don’t do it.  These companies are probably in it for the short term to make quick money then get out before they are busted by the FDA.  If you are serious about building a beauty brand avoid turning your cosmetics into drugs.




  1. Avatar
    Robert Hohf

    Do you have any links to the “The FDA lists a number of drug actives and these can not normally be used in cosmetic products”? I have been looking for this and haven’t found it yet.

  2. Avatar

    “In the US, an ingredient that interacts with living tissue and causes the cells to behave in a way that they normally wouldn’t is considered a drug…”

    But what about the peptides/ vitamin c products, etc. – don’t they behave like drugs on skin, e.g. increase the collagen content of the skin etc.?

    So it’s one thing to claim that, and another to not say anything of this and hope the customer will “know” that somehow – and buy/ love the product, because of the wonderful ingredients =)

    Or take AHAs. The also penetrate the skin and alter cell structure;

    1. Avatar
      Perry Romanowski

      Peptides and vitamins – If they work like they say, they are drugs. So, they typically don’t actually work when applied topically.

      AHAs – They are meant to exfoliate the skin. Since this tissue is dead that is ok to do. Whether they alter cell structure or not hasn’t been definitively proven. That’s why people are allowed to sell them.

  3. Avatar

    Thanks for this info, Perry! Wouldn’t using the description “stimulates” also imply that the product is altering the body’s function? I know the details of cosmetic claims have to be carefully worded and this one confuses me.

    Also, aside from the Food, Drug & Cosmetic Act, are there any other resources you would suggest for understanding the regulatory aspect of the cosmetics industry by state and/or country?

    Thank you!

    1. Avatar
      Perry Romanowski

      “Stimulates” doesn’t really mean anything specifically. Maybe to you it means “increases activity” but stimulating could be something like “makes it feel good” or pretty much anything else you want it to mean. It’s such a vague term that it doesn’t mean anything.

      The FTC is actually also responsible for regulating claims made about consumer products. Plus if you do any media advertising the media outlets (tv, radio, print) all have their own standards by which they judge the appropriateness of claims.

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