Katrina Rosales
The US Food and Drug Administration (FDA) regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). The FD&C Act defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering appearance. This includes perfumes, colognes, and aftershaves, which are regulated as cosmetics by the FDA. However, if a product is intended for therapeutic uses, such as treating or preventing disease, or affecting the structure or function of the body, it is considered a drug under the law.
| Characteristics | Values |
|---|---|
| Definition of cosmetics | Articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body's structure or functions |
| Definition of drugs | Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease or intended to affect the structure or any function of the body |
| Whether FDA approval is required for cosmetics | No, except for color additives |
| Whether FDA approval is required for drugs | Yes |
| Whether perfumes are cosmetics | Yes |
| Whether perfumes can be drugs | Yes, if they are intended for therapeutic use |
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What You'll Learn
- The FDA defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering appearance
- Perfumes are considered cosmetics by the FDA
- Fragrance ingredients in cosmetics are not subject to FDA approval but must be safe for consumers
- Some fragrance products are regulated as pharmaceuticals if they serve therapeutic purposes
- Products with more than one intended use can be classified as both cosmetics and drugs
The FDA defines cosmetics as articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering appearance
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering appearance". This definition includes a wide range of products such as skin moisturizers, perfumes, colognes, aftershaves, lipsticks, fingernail polishes, makeup, cleansing shampoos, permanent waves, hair colors, deodorants, and any substance intended for use as a component of a cosmetic product.
Perfumes, colognes, and aftershaves are regulated as cosmetics by the FDA because they are intended to be applied to the body and make the wearer more attractive. However, some fragrance products are intended for therapeutic uses, such as treating or preventing disease, or affecting the structure or function of the body, and are therefore treated as drugs under the law, or sometimes as both cosmetics and drugs. For example, aromatherapy products that aim to relieve muscle pain or headaches, or fragrances that help with sleep, are generally regulated as pharmaceuticals.
It's important to note that the FD&C Act does not require cosmetic products and ingredients, other than color additives, to have FDA approval before they go on the market. However, cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing them. Additionally, there are laws and regulations that apply to cosmetics on the market in interstate commerce.
The distinction between cosmetics and drugs is based on the intended use of the product. For example, a shampoo is a cosmetic because it is intended to cleanse the hair, but an anti-dandruff shampoo is both a cosmetic and a drug because, in addition to cleansing, it is intended to treat dandruff. Similarly, toothpaste that contains fluoride is considered both a cosmetic and a drug.
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Perfumes are considered cosmetics by the FDA
According to the FDA, perfumes are considered cosmetics, as they fall under the category of products intended to be applied to the human body to make the person more attractive. This definition is outlined in the Federal Food, Drug, and Cosmetic Act (FD&C Act) and includes other items such as skin moisturizers, lipsticks, fingernail polishes, makeup, and cleansing shampoos.
The FD&C Act defines cosmetics as:
> articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering appearance without affecting the body's structure or functions.
Perfumes are specifically designed to be applied to the body and enhance one's attractiveness through scent, thus meeting the criteria for classification as a cosmetic under the FD&C Act.
It is important to note that not all fragrance products are considered cosmetics. Some fragrance products are intended for therapeutic uses, such as treating or preventing disease, or affecting the structure or function of the body. These products are treated as drugs under the law, or sometimes as both cosmetics and drugs, depending on their intended use. Additionally, fragrance ingredients in cosmetics are not currently subject to FDA approval, but enterprises must ensure their safe use. Fragrance ingredients are often listed simply as "Fragrance" or "Flavor" on cosmetic labels, without specifying the exact components.
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Fragrance ingredients in cosmetics are not subject to FDA approval but must be safe for consumers
In the United States, the FDA regulates cosmetics under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Fair Packaging and Labeling Act (FPLA). While the FD&C Act defines cosmetics by their intended use, it does not require cosmetic products and ingredients—except for color additives—to have FDA approval before they go on the market. This means that fragrance ingredients in cosmetics are not subject to FDA approval.
However, fragrance ingredients in cosmetics must meet the same safety requirements as other cosmetic ingredients. Companies and individuals who manufacture or market cosmetics are legally responsible for ensuring that their products are safe and properly labelled. It is illegal for a cosmetic to contain any ingredient that makes the product harmful when used according to the directions on the label or in the customary or expected way.
The FDA does not have the authority to require allergen labelling for cosmetics, unlike for food. However, if a cosmetic is marketed at a retail level, it must have a list of ingredients, usually with each ingredient listed individually. Under U.S. regulations, fragrance and flavour ingredients can be listed simply as "Fragrance" or "Flavor".
The FDA may take action against cosmetics that do not comply with the law and can conduct research on cosmetic products and ingredients to address safety concerns. Manufacturers are encouraged to participate in the FDA's Voluntary Cosmetic Registration Program (VCRP).
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Some fragrance products are regulated as pharmaceuticals if they serve therapeutic purposes
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended 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" (FD&C Act, sec. 201(i)).
Perfumes, colognes, and aftershaves are all considered cosmetics under the law. However, if a fragrance product is intended for therapeutic use, such as treating or preventing disease, or affecting the body's structure or function, it is treated as a drug under the law, or sometimes as both a cosmetic and a drug.
For example, a fragrance marketed for promoting attractiveness is a cosmetic. However, a fragrance marketed with "aromatherapy" claims, such as helping consumers sleep or quit smoking, is considered a drug due to its intended use. Similarly, a massage oil intended to lubricate the skin and impart fragrance is a cosmetic. But if it is intended for therapeutic use, such as relieving muscle pain, it is classified as a drug.
It is important to note that cosmetic products and ingredients are not subject to FDA premarket approval, except for color additives. However, cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing them. Fragrance ingredients in cosmetics must meet the same safety requirements as other cosmetic ingredients. Additionally, if a cosmetic is marketed at a retail level, it must include a list of ingredients, with fragrance ingredients listed simply as "Fragrance" under the Fair Packaging and Labeling Act (FPLA).
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Products with more than one intended use can be classified as both cosmetics and drugs
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering appearance". This includes perfumes, colognes, aftershaves, deodorants, and other products that contain fragrance ingredients to make the user more attractive.
However, if a product is intended for therapeutic uses, such as treating or preventing disease, or affecting the structure or function of the body, it is considered a drug under the law. For example, an anti-dandruff shampoo is both a cosmetic and a drug because it is intended to cleanse the hair (a cosmetic function) and treat dandruff (a drug function).
Some fragrance products fall into this category of having multiple intended uses. For instance, aromatherapy products that are applied to the body and intended to provide therapeutic benefits like relieving muscle pain or aiding sleep are generally regulated as pharmaceuticals or drugs.
Therefore, products with more than one intended use can be classified as both cosmetics and drugs. It is important to note that the regulatory requirements for drugs are more extensive than those for cosmetics. Drugs must receive premarket approval by the FDA or conform to final regulations specifying conditions under which they are generally recognized as safe and effective.
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Frequently asked questions
The FDA defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering appearance".
The FDA defines a drug, in part, by its intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" or "articles (other than food) intended to affect the structure or any function of the body".
Yes, perfume is considered a cosmetic by the FDA because it is applied to the body to make a person more attractive.
A product is considered a cosmetic if it is meant to be applied to the body for cleansing or beautifying purposes. A product is considered a drug if it is meant to treat or prevent disease or affect the structure or function of the body. A product can be both a cosmetic and a drug if it meets the definitions of both.
