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July 13, 2022
John Rizvi, Esq.

Does the Food and Drug Administration Have to Approve My Cosmetic Product Invention?

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If you invented a unique cosmetic product, you’re probably feeling impatient about getting it on the market where it can be purchased, used, and appreciated by others. However, if you’re new to inventing cosmetics, you may be wondering if it’s necessary to seek approval for your product from the Food and Drug Administration (or “FDA”).

In order to answer to that question, we must first ask a completely different question: is your product actually a cosmetic?

You might think of your invention as a cosmetic, but it’s important to find out if the FDA agrees with you.

Is My Product Really a Cosmetic? What the FDA Says

The FDA is explicit about which products it considers cosmetics.

Its definition of cosmetics is laid out in the Federal Food, Drug and Cosmetic Act, or the FD&C Act for short.

The FDA says that cosmetics are “to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”

If that isn’t entirely clear, maybe this will help: some examples of what constitute cosmetics in the eyes of the FDA include perfume, moisturizers, nail polish, makeup (and that includes lipstick), hair dye, deodorant, cleansing shampoo, and home permanents, as well as any individual components of a cosmetic product.

Soap is a Special Case

Where does soap enter into the equation? Well, soap is treated a little differently than other products you might view as cosmetics.

The FDA doesn’t regulate soap at all. The Consumer Product Safety Commission (CPSC) does.

However, it’s important to understand that what you think is soap and what the FDA thinks is soap could be very distinct things.

It comes down to two points:

  • What the product’s advertising and packaging say it does; and
  • How the product is produced.

Let’s break it down.

What its Advertising and Packaging Say it Does

If the product’s advertising and packaging indicate that the product is used for cleaning, it might be soap. However, if it also claims to do other things for you, such as making you smell nice or treating skin conditions, then it’s definitely not soap, according to the FDA.

  • If the product is promoted as deodorizing or perfuming your body, the FDA considers it a cosmetic.
  • If the product is promoted as preventing or treating skin conditions, or killing germs, the FDA considers it a drug – and that’s a whole other can of worms.

Stated another way, the only products the FDA considers soap are products that are promoted as doing just one thing: cleaning. However, in order to be considered soap, it also has to be made a certain way.

How the Product is Produced

In addition to considering how a product is packaged and advertised, the FDA also defines soap by how it’s produced.

In order for a product to be soap, it must be made mostly from alkali salts. An example of how soap is made with alkali salts is when a soap maker combines oils or fats with an alkali, like lye. Alkali salts are the byproduct.

If the product you consider “soap” is intended to clean, but also work as a deodorant or to fragrance the body, then what you have is a cosmetic, according to the FDA.

When You Didn’t Realize You Invented a Drug

As we said above, if you have a product that you view as soap, but which is promoted as killing germs or preventing/treating skin conditions (like psoriasis or acne, for example), the FDA considers your product a drug – not soap.

Drugs are regulated by the FDA and treated very differently from cosmetics.

Can Your Product Be Considered Both a Drug and a Cosmetic?

Sure, it’s possible that your invented product could be considered both a drug and a cosmetic by the FDA. If that’s the case, your product must meet the FDA’s requirements in both the drug and cosmetic categories.

Does Your Cosmetic Product Need FDA Approval?

As long as your product is considered a cosmetic by the FDA and not a drug or soap, you don’t have to worry about obtaining FDA approval. The FDA doesn’t require the approval of cosmetic products or the ingredients you use to make them, with one exception: color additives.

Because the FDA doesn’t approve cosmetics, you don’t have to worry about product testing.

However, there are times when the FDA pays attention to cosmetic products. For example:

  • If the FDA learns that a product might be unsafe and cause harm, it may run its own tests on the product to make sure it’s OK.
  • The FDA may not regulate cosmetic products, but it does regulate their labels. Any cosmetic product distributed in the U.S. is required to adhere to the FDA’s labeling requirements.
  • If any cosmetic product fails to comply with the law, the FDA can step in and legally force the manufacturer to do so.
  • The FDA prohibits cosmetics that are considered “misbranded” or “adulterated.” You can find out more on the FDA’s website.

School Yourself and Keep Your Nose Clean

The FDA doesn’t fool around. It’s important that you comply with their requirements.

Before you take your cosmetic product invention to market, make sure you’re well-informed about how your product should be labeled, and ensure that what you’re selling is not considered by the FDA to be “adulterated” or “misbranded.”

Furthermore, if your product is soap-like, make sure that the FDA truly does consider it soap, and not a cosmetic or drug.

If the FDA views your product strictly as a cosmetic, it won’t require FDA approval.

However, if your product’s packaging or advertising promotes its use in preventing or treating skin conditions or killing germs, you must follow all of the FDA’s requirements for a drug.

Finally, if the FDA considers your product soap, you’ll want to check with the requirements of the Consumer Product Safety Commission, which regulates soap.

You Invented a Cosmetic Product, But Are You Sure It’s Really Yours?

When a person invents something new, they instantly feel a strong sense of ownership over the idea.

It’s your cosmetic product. You created it from scratch. And now, you’re going to take it out into the world and let it fill your pockets.

Before you get too excited, there’s something important you should know.

Just because you came up with an idea for a cosmetic product doesn’t mean you own it and can begin making money from it. You don’t really own that invention unless you own a patent on it.

A patent is kind of like a deed to a house or a car. It’s proof of ownership.

In order to get a patent and lock down ownership on your product idea, you need to work with a talented patent attorney who knows how to write a strong patent application that will make it difficult for others to copy your product, and then they will interact with the United States Patent and Trademark Office (USPTO) to get an official patent issued for your invention.

Unfortunately, many people who think they know how patents work don’t realize that being the first person to come up with an idea doesn’t necessarily mean you’ll get a patent in the United States.

In fact, the USPTO works on a “first-to-file” basis. This means they will give a patent on an invention to the first person who files an application for it, whether they were the first person to have the idea or not.

Forget about proving to the USPTO that you were working on that cosmetic product before anyone else. Forget about telling them that someone you know stole your idea and filed a patent application for it themselves. None of it matters to the USPTO.

Quite simply, it’s a race to see who gets a patent application filed for the invention first.

So, what does this mean for the cosmetic product you invented?

It means you have to act fast.

Not only could someone steal your idea and get a patent on it, but there’s a strong possibility that somebody else out there has the same idea that you do. If they file their patent application first, you can forget about making or selling your own product. It belongs to them now.

If you want to protect your cosmetic product invention, first, STOP TALKING ABOUT IT. Keep it confidential. Second, contact a skillful patent attorney to help you obtain a strong patent.

The Patent Professor® has been helping individual inventors and small start-ups obtain patent protection for over two decades. They bring the same level of skill to “small-timers” that is enjoyed by mega-corporations with armies of patent attorneys on staff. Let The Patent Professor® level the playing field for you, lock down protection on your cosmetic product, and get you on the road to making your dreams come true.

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The information in this blog post (“post”) is provided for general informational purposes only and may not reflect the current law in your jurisdiction. No information in this post should be construed as legal advice from the individual author or the law firm, nor is it intended to be a substitute for legal counsel on any subject matter. No reader of this post should act or refrain from acting based on any information included in or accessible through this post without seeking the appropriate legal or other professional advice on the particular facts and circumstances at issue from a lawyer licensed in the recipient’s state, country, or other appropriate licensing jurisdiction.
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