“Cosmetics,” “personal-care products,” “makeup”: it’s not uncommon to see these terms, and others, used interchangeably. Certainly, with words like “makeup” or “skin-care products,” it’s pretty clear what’s being described. But terminology can be tricky, particularly in the Internet age, when so much information is available so freely, and when it’s not uncommon to play fast and loose with language.

But it turns out that a “cosmetic” is a specific category of products, at least in the United States.

In the US, the Food and Drug Administration is the organization responsible for regulating cosmetic products (as well as food and drug products, of course). The FDA has a specific set of guidelines for what qualifies as “cosmetic,” and for any product that does, the manufacturer must follow specific rules so that the product can be legally sold. Sometimes, a product is also considered a “drug,” and it has to follow the rules for that classification, as well.

Let’s look into this.

What is a cosmetic product?

The FDA defines a cosmetic product as:

a product (excluding pure soap) intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.

The definition is based on “intended use,” which is influenced by product claims, consumer perception, and formulation. Any product that falls into the cosmetics category is subject to FDA laws and regulations. This goes both for cosmetics offered for import and those that are produced in the United States. In general, “cosmetic products” include regular cleansers, makeup, moisturizers, deodorants, and the like.

Notice we said “deodorants are cosmetics.” Be careful with antiperspirants; those are classified as drugs. Why is that?

Now, what’s a drug?

According to the FDA, a drug is defined as:

• A substance recognized by an official pharmacopoeia or formulary.
• A substance intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.
• A substance (other than food) intended to affect the structure or any function of the body.
• A substance intended for use as a component of a medicine but not a device or a component, part or accessory of a device.

This definition is also based in part on intended use.

It might not be obvious, but the definition of “drug” can also apply to some products that we apply to our bodies for aesthetic reasons: anti-acne treatments, for example. Or antiperspirants: those mask odor, yes, but they also affect a bodily function by inhibiting sweating.

Some products (like antiperspirants) are both cosmetics AND drugs. These products must comply with the laws and regulations for both product categories.

Can a product be cosmetic AND a drug?

The FDA website offers some specific information about products that count as both cosmetics and drugs. It states:

Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.

Even if a product is marketed as a cosmetic, if it claims to have some effect on the body’s structure or functions—like restoring hair growth, reducing cellulite, treating varicose veins, or increasing or decreasing the production of pigment in the skin (called melanin)—then it’s a drug.

In other words, if your foundation has an SPF factor, then you might be marketing it to improve appearance, but it also counts as a drug, so it has to meet the rules for both categories before you can sell it. So does, say, a massage oil that says it reduces muscle ache.

If you aren’t sure if a product is a cosmetic or a drug, you can find out more at the “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)” page on the FDA’s website. On Goldn, you can also connect with a regulatory consultant who can make sure your product is fully compliant, so you can go to market with confidence.

Wait, how is soap different from a cosmetic?

There’s another wrinkle. See that parenthetical phrase up there in the cosmetics definition? The one that says “excluding pure soap”? Products that meet the specific definition of “soap” are neither cosmetics nor drugs, and they aren’t regulated by the FDA at all.

Soap is regulated by the Consumer Product Safety Commission, a different government body.

Here are the basic rules. Per the FDA, for a product to be “soap”:

• the bulk of the non-volatile matter in the product consists of an alkali salt of fatty acids and the product’s detergent properties are due to the alkali-fatty acid compounds, and
• the product is labeled, sold, and represented solely as soap

This is a strict rule. If it is only intended as a cleanser and would be generally recognized as “soap” by consumers, but does not consist primarily of alkali salts of fatty acids, then you might call it “soap,” but it’s actually a cosmetic, and it is FDA-regulated. If it has detergents, or if it also moisturizes, it’s a cosmetic. If it’s antibacterial, it’s a drug as well.

For more information, see the FDA’s “Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)” page, or connect with a regulatory adviser on Goldn for expert advice.

How does all of this affect me?

Creators should be crystal-clear on the intended effects and the marketing claims that they plan for their products to have, so they don’t get in trouble with the government.

Fortunately, there are many expert partners whose business is to help guide creators through the regulatory process and clear the way to a successful product launch.

Nevertheless, it’s important to have a good idea from the start what will be required, so no time-consuming, costly surprises come up mid-development process. Let’s look at some of the highlights.

This isn’t a comprehensive list of what cosmetic and drug makers must do in order to meet regulatory requirements. It’s a helpful guide to get you started and point you in the right direction.

Summary:

• Cosmetic products do not require FDA approval before marketing.
• Drugs must EITHER get approval from the FDA (known as an NDA) OR conform to a “monograph,” which is a type of official document describing a specific category of well-known and established drug.
• Cosmetics are not subject to binding requirements for good manufacturing practices (GMPs), while drugs must strictly follow GMPs. (The FDA provides guidelines on GMPs for cosmetics, though.)
• Registration with the FDA is voluntary for cosmetics, and mandatory for drugs.
• Cosmetics must follow cosmetic labeling requirements, whereas drugs must follow regulations for over-the-counter drug labeling (including the Drug Facts box you see on over-the-counter medicines at the pharmacy).

The FDA is the place to go with more in-depth queries. If you have questions on drug regulations, the FDA says to start with the Center for Drug Evaluation and Research.

How do I make a cosmetic product, drug, or soap?

You have completed the first step: know the difference. Creators of cosmetic products with an eye on the American market are obliged to follow specific regulatory requirements. That starts with making sure you know which classification correctly applies to your product—or if there are more than one.

We’ve provided some helpful links, and the whole Food and Drug Administration website is informative and useful. Also, there are many regulatory consultants out there to help you navigate, and many of them will be found right here on Goldn.

Working with an expert can help make sure that you meet all your requirements the first time, so you can go to market quicker and more hassle-free.

Whether your vision is a cosmetic product, a drug, or both, we’d love to connect you with the right partner, so you can bring it from idea to formulation to store shelves.

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