Are Cosmetics Regulated by the FDA?

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Are Cosmetics Regulated by the FDA?

There are misconceptions galore out there about what the U.S. Food and Drug Administration (FDA) has to do with cosmetics. Do they or don’t they regulate makeup and beauty products the same way they regulate drugs? Inquiring minds want to know! The answer, so it seems, is both yes and no. I’m not an attorney, but I think it breaks down a little something like this:


Drugs and premarket approval

The FDA treats drugs and cosmetics differently, except when they’re one and the same (more on that in a minute). For public safety, the distinction matters because the FDA subjects drugs to premarket approval, taking a closer look at their safety before they ever go on sale.

What about cosmetics?

Cosmetics, however, aren’t really examined by the FDA before they end up at Sephora, Nordstrom or MAC. The FDA still requires that beauty products list their ingredients, and they can shut down companies for making misleading claims (although we still see these claims made all the time) or for putting the public at risk, but when you get right down to it, makeup isn’t approved by the government before it winds up at the store.

BOTTOM LINE: With drugs, the FDA takes responsibility for ensuring their safety before they hit the market; with cosmetics, this responsibility falls to the manufacturer, who can be penalized for breaking the rules, but it’s mostly after the fact. 😉

When it’s both a cosmetic AND a drug

Now, there’s one big “but,” and it has to do with products the FDA says are both a cosmetic AND a drug.

Drugs, according to the FDA, are products intended to help treat or prevent disease or to change the way the body works — an often subjective definition that covers lots of beauty and personal care products like dandruff shampoos and many anti-aging skin creams.


If a product has been classified as both a cosmetic and a drug, it must pass the FDA’s premarket approval. In other words, the FDA tries to make sure the product is safe before it goes on sale.

It’s complicated (and there’s even WAY more to it than this), but for more information on cosmetics and the U.S. FDA, check out FDA Authority Over Cosmetics and Cosmetic Labeling & Label Claims. For details on Canada’s guidelines on the regulation of cosmetics, see The Food and Drugs Act and Cosmetic Regulations, and for info on the regulation of cosmetics in the European Union, visit Premium Beauty News.

How do you feel about cosmetics and the FDA? Do you think makeup is well regulated? Share your take on it in the comments.

Your friendly neighborhood beauty addict,



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So far, 13 people have commented on this article. How cool is that?

  1. Smiley says:

    I think this is pretty important stuff. Thanks for informing us about it! I think we should always be careful especially when makeup can break us out and such. It would be nice if it was regulated by the FDA though.
    .-= Smiley’s last blog post… Recess Review =-.

  2. Roxanne says:

    Thanks for the info! I guess I never really thought about that, I always assumed make up and such have to pass very rigorous testing before making it on the market. This article has definitely changed my view of make up and cosmetics. Better watch out from now on…

  3. Sharon says:

    I wish they were tested by the fda. Some cosmetic companies make some ridiculous claims and i wish they were put up to a higher standard. It’s good to know they aren’t tested because it’ll certainly make me more careful before i buy.

  4. BlovetBeauty says:

    Well, I think if all the cosmetics and beauty products were to be checked, almost half of it wouldnt make it onto the shelves. There are so many added ingredients that we dun even know about…..its kinda scary sometimes
    .-= BlovetBeauty’s last blog post… Black Rimmed Eyes =-.

  5. Shannon says:

    To be perfectly honest, I’m not scared at all by whatever goes into my makeup, for the most part. Cosmetic companies (especially large ones) have a rep to maintain. If a product is potentially dangerous, they’re not going to sell it to customers. You can probably rest assured that MAC wouldn’t be able to sell all the makeup they do if their products contained dangerous ingredients. People would start breaking out, getting burnt, I dunno…
    A lot of testing has already been done with makeup and makeup products. Even if products aren’t regulated by the FDA, they’re effectively regulated by a company’s need to produce quality cosmetics.

    • Karen says:

      Hi, Shannon. In general I agree. For sure, the profit motive keeps most companies honest, but I don’t see acute, easily recognizable symptoms like burns and breakouts as carrying the most risk. It’s the potentially carcinogenic stuff that may take years to manifest that worries me more. If a lipstick contains a little-known compound that’s only found to be carcinogenic 10 years from now, after the customer’s stopped using the product, it may be too late by then to tie it to the customer’s cancer, and the person may actually never even know what caused their illness.

      That’s why I’m on the fence about this… Part of me doesn’t trust the FDA any more than anyone else, but another part of me thinks that having the FDA chemically analyze cosmetics before they’re brought to market could maybe help catch things that the companies may not even recognize in their products. The chemists working for the big makeup companies are great, but they don’t have access to the same resources that the chemists working for the FDA have.

      Thanks for leaving such a thought-provoking comment! I hope your week got off to a good start. 🙂

  6. singrsling says:

    Makeup is tested before it goes on the shelves, but remember that folks who have sensitive skin or allergies can react badly to certain ingredients, just like with allergies to medications. I am also very careful about where it is made – ie which country. For example, I don’t buy some of the popular drugstore makeup, because they are made in China, and I’m not confident of the quality yet. I just hate the stupid claims that some cosmetic companies make about removing wrinkles, spots, clearing up acnes, etc. Very misleading wording!

  7. BeckBeck says:

    Thanks for this post, Karen – it’s really a refreshing and thought-provoking thing to run into on a beauty blog! I personally think that there are many more pressing matters to handle before we ask the FDA to start testing and approving our moisturizers. I’m a pharmacist, and I think the FDA does the best they can, but I’ll be the first one to tell you they’re not perfect. But maybe some enterprising young docs in the field of dermatology could wring a few postgrad projects out of studying “active ingredients” in the world of face creams. 🙂

  8. keegan says:

    It seems to be up to the company itself to establish ingredient safety, which is disturbing me greatly. This is why I do my own research of ingredients and I always read labels. If you become familiar with common makeup/skincare ingredients you can save yourself a lot of money. You will also become familiar with those “controversial ingredients” like parabens and sulfates, then decide to avoid them or not. There are certain ingredients that actually work, then there are the ingredients that are cheap & potentially harmful. cheap = more profit.

    What’s worse is that although non-prescription cosmetics/skincare products are NOT required to be tested on animals, they still are. I can’t stand the thought of one of my little furbabies getting mascara jammed in their eyes all day.

    Quote from the FDA website:

    “The FD&C Act does not specifically require the use of animals in testing cosmetics for safety, nor does the Act subject cosmetics to FDA premarket approval. However, the agency has consistently advised cosmetic manufacturers to employ whatever testing is appropriate and effective for substantiating the safety of their products. It remains the responsibility of the manufacturer to substantiate the safety of both ingredients and finished cosmetic products prior to marketing.”
    .-= keegan’s last blog post… Best Lip Plumping Glosses =-.

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