Cosmetics FDA Florida IP
I Invented a Cosmetic Product. Do I Need FDA Approval?
You developed a cosmetic product and you’re excited to get it on the market. But you’re new at this. You may have been reading about how cosmetic products get from your kitchen laboratory to the store shelves, and maybe you came across references to getting approval from the FDA, or Food and Drug Administration.
The first step before dealing with the FDA is figuring out if your product is considered a cosmetic according to the FDA’s guidelines.
Does the FDA Consider my Product a Cosmetic?
The FDA sets out its definition of cosmetics in the Federal Food, Drug and Cosmetic Act, a/k/a the FD&C Act, as products that 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.” Examples of such products include:
- Hair coloring
- Nail polish
- Makeup, including lipstick
- Home perms
- Deodorant
- Moisturizer
- Cleansing shampoos
- Perfume and cologne
- Any individual component of a cosmetic product
It’s worth noting that soap is regulated by the Consumer Product Safety Commission (CPSC), not the FDA. However, the FDA’s definition of soap is very specific.
Is it soap, according to the FDA? It is if it’s going to be packaged and advertised as a product that cleans – and nothing else.
Also, how the soap is made matters. The FDA will only consider a product soap if it’s made primarily of alkali salts that are the product of combining fats or oils with an alkali (such as lye).
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.
- the only material in the product that actually cleans are the alkali salts of fatty acids. If there’s any other ingredient in the product that also cleans, the product is not regulated by the FDA as soap (although you can still use the word “soap” on the label).
Is it a Cosmetic, or a Drug?
In some cases, a product that most people would view as a cosmetic might actually be classified as a drug by the FDA. For example, if your product is intended to kill germs, or prevent or treat disease (including acne, psoriasis, and other skin conditions), then the FDA might call it a drug. It’s important to note that drugs and cosmetics are treated very differently by the FDA. A drug will be subject to a unique set of regulations.
Is There Such a Thing as a Drug/Cosmetic Combo?
It’s entirely possible that a product could be defined as both a drug and a cosmetic by the FDA. In that situation, the product will be required to meet all of the FDA’s requirements for both cosmetics and drugs.
How Do You Get Cosmetics Approved By the FDA?
The fact is, the Food and Drug Administration does not require approval of cosmetic products or their ingredients, with the exception of color additives.
Since the FDA doesn’t approve cosmetic products, it also doesn’t require cosmetic products to be formally tested.
Do I Need to Worry About the FDA At All?
Just because the FDA doesn’t approve or require testing of cosmetics doesn’t mean it has no involvement in cosmetic products.
For example:
Safety Concerns. When the FDA becomes aware that a cosmetic product might be harmful, they may step in to test and analyze the product to ensure its safety.
Regulating Labels. Even though the FDA doesn’t regulate cosmetics, it does regulate the way cosmetic products are labeled. If a cosmetic product is distributed in the United States, it must follow the FDA’s labeling requirements.
Law Enforcement. If a cosmetic product does not comply with the law, the FDA can take legal action to enforce compliance.
“Misbranded” or “Adulterated”. Cosmetics that are “misbranded” or “adulterated” are prohibited. Learn more here.
If you’ve invented a cosmetic product and you want to take it to market, it’s important that you educate yourself. Be sure that you comply with the FDA’s requirements around cosmetic labeling and avoid selling products that are considered adulterated or misbranded. Take the time to determine if your cosmetic might actually be considered to be a drug or soap by the FDA, as those products are subject to their own sets of rules.
Protecting Your Cosmetic Idea from Theft
Most people don’t realize how easy it is for someone to steal an idea – legally.
Imagine someone else selling your cosmetic product – the exact product you invented and worked so hard to develop – and putting profits into their pocket that should have been yours. A heartbreaking thought, isn’t it?
Now imagine yourself trying to stop them. You tell them, “Hey, I came up with this idea before you did, and I have proof!”
They reply, “Yes, I know you did. But I took your idea to the Patent Office and got a patent on it. Now I’m the only one with the legal right to make money on your idea. So that means you have to stop selling it, too.”
Infuriating, right? Can you sue them and take your idea back?
No, you can’t.
The United States Patent and Trademark Office works on a “first to file” system. It doesn’t matter if you were the first person to come up with an idea. Anyone can take that idea and get a patent on it, even if you have mountains of evidence that you were working on it first. Even if you can prove that they knew about your idea and stole it.
The only thing that matters is who files the patent application first.
When you have a patent on a cosmetic product or idea, you own it. You have the legal right to prevent anyone else from selling it. So, yes, someone else can take your idea and stop you from profiting from it!
That’s why it’s so important to keep your cosmetic product idea TOP SECRET until you file a patent application. We can help.
Contact us today for a consultation that’s 100% free and confidential. We’ll help you understand how to protect your cosmetic product idea.
FDA regulations are subject to change. Consult the FDA to ensure that you have the most up-to-date, complete information pertaining to cosmetics.