Product Regulation & Oversight

How Cosmetics Are Regulated in the U.S.

Cosmetics and Personal Care Products Companies are Committed to Upholding Strict Regulations by the U.S. Food and Drug Administration (FDA)

Consumer safety is a top priority for cosmetics and personal care products companies, and manufacturers are committed to upholding strict FDA regulations as required by the Food, Drug, and Cosmetic Act (FD&C Act). The long-awaited Modernization of Cosmetics Regulation Act (MoCRA) of 2022 adds significant new authorities to the FD&C Act, advances product safety and innovation for the science-driven beauty and personal care industry and reinforces consumer confidence. As a result, the FDA will have new tools to regulate cosmetics and personal care products consistently.

Cosmetics companies take their safety responsibility very seriously and often surpass the requirements of the law with additional consumer safety measures such as ingredient/formula selection, consumer and clinical evaluations, stability testing, labeling, quality control and secure packaging choices.

Consumers must have confidence in the products they use and trust every day. The U.S. cosmetics industry invests millions of dollars in scientific research and development to support the safety and efficacy of approximately 2,000 new products introduced each year. Companies employ thousands of medical and scientific professionals – including chemists, toxicologists, biologists, environmental scientists and other experts – to evaluate, substantiate and ensure product and ingredient safety.

Science and Safety are the Cornerstones of the Industry.

As a result, of the billions of personal care products sold each year in the United States, there are very few adverse experiences reported to the FDA in a typical year. Of those reported, most are related to rashes or allergies. Cosmetics companies’ strong commitment to safety makes cosmetics and personal care products one of the safest product categories regulated by the FDA.

Cosmetics and personal care products companies have long provided more product, safety and technical information than required by law. Voluntary industry programs to support the FDA’s regulatory work included:

The enactment of the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 makes many of the industry’s voluntary activities mandatory, increasing transparency and giving greater assurance to consumers that their products are safe.

The CIR: Cosmetic Ingredient Review

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Cosmetics Industry Consumer Commitment Code

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FDA/Company Registration Program

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Cosmetic Ingredient Dictionary

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Cosmetics and Personal Care Products Companies are Committed to Upholding Strict Regulations by the U.S. Food and Drug Administration (FDA)

Science and Safety are the Cornerstones of the Industry.

The CIR: Cosmetic Ingredient Review

Learn More

Cosmetics Industry Consumer Commitment Code

Learn More

FDA/Company Registration Program

Learn More

Cosmetic Ingredient Dictionary

Learn More

About The FDA

The U.S. Food and Drug Administration (FDA) Has Broad Authority to Regulate Cosmetics and Personal Care Products

Strong federal safety requirements govern cosmetics and personal care products sold in the U.S. It is a crime to market unsafe cosmetics products. The U.S. Food and Drug Administration (FDA) and the U. S. Attorney General (AG) can take action against any company that markets an unsafe cosmetics product. The law provides severe penalties, including seizures, recalls, fines and bans, for cosmetics and personal care products manufacturers that do not meet these strict requirements.

DID YOU KNOW: All cosmetics and personal care products manufacturers are required by federal law to substantiate the safety of their finished products and ingredients.

The FDA has wide-ranging regulatory authority that helps to ensure the safety of cosmetics and personal care products. In the past, the FDA has infrequently had to exercise this power to limit or prohibit ingredients that it considered to be unsafe. Cosmetics and personal care products companies are committed to upholding strict FDA regulations.

Food, Drug, and Cosmetic Act
FDA and Over the Counter

The Federal Food, Drug, and Cosmetic Act (FD&C Act) of 1938 and the Modernization of Cosmetics Regulation Act (MoCRA) of 2022 requires that every cosmetics product and its individual ingredients be substantiated for safety and that product labeling be truthful and not misleading. Cosmetics manufacturers are responsible for ensuring that products comply with the law before they are marketed. This process includes analyzing a cosmetic ingredient’s testing and safety data. If the manufacturer is unable to substantiate the safety of a product, the law requires the product to carry a conspicuous warning stating that its safety has not been substantiated.

The law provides severe penalties for products that do not meet these standards. Specifically, the law gives the FDA authority to:

Ban or restrict cosmetics ingredients for safety reasons
Mandate warning labels
Inspect manufacturing facilities and records
Issue warning letters
Seize unsafe or misbranded products
Prohibit unlawful activities
Prosecute and jail violators
Mandate product recalls
Collect samples for examination and analysis as part of cosmetics plant inspections, import inspections and follow up to complaints of adverse reactions
Conduct research on cosmetics and personal care products and ingredients to address safety concerns

In addition to the FD&C Act and MoCRA, the Fair Packaging and Labeling Act authorizes the FDA to require ingredient labeling of cosmetics and personal care products sold to consumers. Detailed FDA regulations govern where and how ingredients must be listed on the package.

Cosmetics’ continued safety is ensured by the FDA’s regulatory program, as well as additional safety measures undertaken by the cosmetics and personal care products industry and the decades of safe use by consumers who trust and enjoy them every day.

FDA Also Has Authority to Regulate Personal Care Products That Contain Active Ingredients That Are Over-The-Counter (OTC) Drugs

Over-the-counter drugs (OTC) are subject to FDA approval. Generally, drugs must either receive pre-market approval by the FDA or conform to final federal regulations specifying conditions whereby they are generally recognized as safe and effective. Once a regulation covering a specific class of OTC drugs is proposed, reviewed and finalized (in what is known as an FDA OTC Drug Monograph), these drugs must either comply with the requirements of the monograph or be required to submit a New Drug Application (NDA) to the FDA for review and approval.

Cosmetic Companies’ Commitment to a Strong FDA

The cosmetics and personal care products industry supports a strong and vigilant FDA. The FDA has abundant regulatory and enforcement authority for cosmetics under the federal Food, Drug and Cosmetics Act (FD&C Act) of 1938 and the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. Consumers benefit from having the FDA as a strong watchdog for their health and safety, and industry benefits when consumers are confident in the safety standards set by the Agency. Cosmetics companies work diligently to provide products that are safe, effective and comply with the provisions of the law.

How Cosmetics and Personal Care Products are Regulated in Other Countries

Cosmetic Safety is Ensured Worldwide

Throughout the world, cosmetic and personal care products manufacturers work to create and market safe and elegant products that help consumers to look and feel their best. To further ensure the safety of cosmetic products, different countries employ different measures to achieve this goal. However, the stringent regulations governing cosmetics in each country or jurisdiction, have one common goal: To protect the consumer by ensuring safe ingredients and finished products.

View more information on cosmetic regulation in the EU.
View more information on cosmetic regulation in Japan.
View more information on cosmetic regulation in Canada.

Cosmetic Regulation Around the Globe

Cosmetic Regulation in the European Union

The European Union Cosmetics Directive defines a cosmetic as “any substance or preparation intended to be placed in contact with the various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity with a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odors and/or protecting them or keeping them in good condition. “The European Union requires that cosmetic products placed on the EU market be safe; that is, they “must not cause damage to human health when applied under normal or reasonably foreseeable conditions of use.” As in the U.S., manufacturers are responsible for ensuring that cosmetic products comply with the law before they are marketed. The manufacturer or importer of cosmetics is responsible for demonstrating that the product is safe for its intended use. Regulations are enforced at the national level, and each country in the EU has an authoritative body that is responsible for upholding compliance.

Cosmetic Regulation in Japan

The Japanese government regulates the cosmetics industry through its Ministry of Health, Labor and Welfare according to the Pharmaceutical Affairs Law (Law No. 145) established August 10, 1960. Japan has adopted a list of prohibited ingredients, a list of restricted ingredients, a positive list of UV filters and a positive list of preservatives. Other than these restrictions, the burden of ensuring product safety has been shifted to cosmetic manufacturers. As such, any ingredient that can be shown to be safe may be used in a cosmetic product. Until recently, a manufacturer or importer of cosmetics was required to obtain a pre-market approval and license from the Ministry of Health, Labor and Welfare. Since 2001, however, Japanese cosmetics companies are required only to provide notification of the product’s brand prior to manufacturing or importing. Japan is an excellent example of a nation where costly pre-market registration procedures were replaced with manufacturer responsibility for product safety and with post-market surveillance (similar to the systems in the U.S. and EU) without compromising consumer safety.

Cosmetic Regulation in Canada

The Canadian government regulates the cosmetics industry through Health Canada’s Cosmetics Program. The basis for the regulatory authority for the Cosmetics Program comes from the Food and Drugs Act and Cosmetic Regulations. Cosmetics are defined as “any substance or mixture of substances, manufactured, sold or represented for use in cleansing, improving or altering the complexion, skin, hair or teeth and includes deodorants and perfumes.” This definition also includes cosmetics used by professional esthetic services, as well as bulk institutional products (e.g. hand soap in school restrooms).

Health Canada’s Cosmetics Program has the mandate to protect the health of Canadians by minimizing the risk associated with the use of cosmetics marketed in Canada. The program defines and communicates requirements for the manufacture, labelling, distribution and sale of cosmetics, and evaluates compliance.

As in the U.S., manufacturers are responsible for ensuring that products comply with the law before they are marketed. The manufacturer or importer of cosmetics is responsible for demonstrating that the product is safe for its intended use. Regulations are enforced by Health Canada and is overseen by Product Safety Officers who manage inspections, investigations, seizures, recalls and prosecutions from regional offices.

The United States and European Union

The United States and European Union: Strictly Regulating Cosmetic Safety

The United States (US) and European Union (EU) both work to ensure the safety of cosmetics for consumers through rigorous regulation. In the United States, the cosmetics industry is regulated by the U.S. Food and Drug Administration (FDA) which has been granted broad regulatory authority under the federal Food, Drug and Cosmetic Act (FD&C Act), enacted in 1938, and the Modernization of Cosmetics Regulation Act (MoCRA) of 2022. The 27 European Union Member States have transposed the European Union Cosmetics Directive, enacted in 1976, into national law. Each Member State has health authorities which then regulate cosmetics within their respective national boundaries according to the law.

In both the United States and the European Union, cosmetics manufacturers ensure product safety prior to marketing, list all ingredients on the product label and comply with any restrictions that are established for cosmetic ingredients and products. Any potential risk from a product is assessed as part of its safety evaluation.

In the U.S., the Cosmetic Ingredient Review (CIR) Expert Panel conducts independent safety reviews of ingredients as a part of the cosmetic safety process, with the results published in the International Journal of Toxicology and on the CIR website. The EU Scientific Committee on Consumer Safety is responsible for reviewing all special and active cosmetic ingredients and assessing conditions for safe use. The results are subsequently published on the Committee’s website.

In the United States, cosmetic and personal care products companies work with leading scientific and medical experts every day and invest millions of dollars in sophisticated laboratory equipment and facilities to ensure cosmetic product safety. In addition to this strong commitment to safety, federal law requires that every cosmetic product be substantiated for safety before it goes to market. The FDA statistics confirm that cosmetics are one of the safest product categories used by Americans today.

The U.S. and EU have slightly different ways of regulating the cosmetic and personal care industry, but both systems provide consumers with a high degree of safety. Some argue that cosmetics are more strictly regulated in the EU, citing recent actions taken in the EU to red flag or ban certain chemicals from use in cosmetics. However, an examination of Annex II of the EU Cosmetics Directive, a list of approximately 1,300 banned ingredients, reveals that a large number of those chemicals are not used and never have been used in cosmetics in the U.S. or Europe. For example, the EU list includes substances such as jet aircraft fuel, various petroleum refinery byproducts and carbon monoxide.

Another difference between the EU and U.S. systems of regulating cosmetics is that the EU allows the marketing of cosmetic products with certain medicinal effects, while the United States has required extra regulatory hurdles because they are classified as drugs. Some of the products include sunscreens, anti-caries toothpaste and lip balms. Even though color additives are not classified as over-the-counter (OTC) drug actives, they are also subject to more regulatory scrutiny in the U.S. than they are in Europe.

Cosmetic Ingredient Dictionary

The Cosmetic Ingredient Dictionary

Authored by the Personal Care Products Council (the Council), the trade association for the cosmetic and personal care industry, the International Cosmetic Ingredient Dictionary and Handbook provides a comprehensive listing of ingredients used in cosmetic and personal care products for the benefit of consumers, the U.S. Food and Drug Administration (FDA), and manufacturers. The combined dictionary/handbook contains more than 13,000 International Nomenclature Cosmetic Ingredient (INCI) labeling names for the United States, the European Union, and other countries. These are cross-referenced to nearly 60,000 trade and technical names and 3,000 suppliers from 91 countries.

Benefits for Consumers

The need for uniformity in cosmetic ingredient nomenclature has been recognized in countries around the world. There are numerous benefits to a uniform system of labeling names for cosmetic ingredients, including the consistency and transparency provided to consumers as ingredients are identified by a single labeling name regardless of the national origin of the product. Scientists and dermatologists are also ensured that information will be referenced by a uniform name, eliminating the possibility of confusion or misidentification from the use of multiple names for the same material.

History

The first edition of the Cosmetic Ingredient Dictionary was published in 1973 and was cited by the U.S. Food and Drug Administration as the primary source of ingredient names for the FDA regulation requiring cosmetic ingredient labeling (U.S. Title 21, Code of Federal Regulations, Part 701.3). The 13th edition of the dictionary was published in 2010.

Other Key Information

In addition to ingredient names, the dictionary also includes information on the chemical class, functions and product use categories as reported to the U.S. Food and Drug Administration (FDA), when available. It provides information on Chemical Abstract Service (CAS) numbers, empirical formulas, and over-the-counter drugs and includes an index that cross-references Latin and common English botanical names, a Japan index that lists prohibited and restricted ingredients, a list of ingredients evaluated for safety by the Cosmetic Ingredient ReviewThe Cosmetic Ingredient Review (CIR) was established in 1976 as an independent safety review program for cosmetic ingredients. The CIR Expert Panel consists of independent experts in dermatology, toxicology, pharmacolgy and veterinary medicine. The CIR includes participation by the U.S. Food & Drug Administration and the Consumer Federation of America. (CIR) Expert Panel, and references to appropriate EU Annexes.

FDA/Company Cosmetic Registration Program

Previously, cosmetics and personal care products companies voluntarily participated in the FDA Voluntary Cosmetic Registration Program (VCRP).

The VCRP was an FDA post-market reporting system for cosmetics products and ingredients, along with their frequency of use, for manufacturers, packers and distributors of cosmetics products in commercial distribution in the United States.

Effective March 27, 2023, the FDA announced it no longer accepts submissions to the VCRP in preparation of launching a new platform for facility registration and product listings. The new system will better align with the reporting requirements of the Modernization of Cosmetics Regulation Act (MoCRA) and will help FDA in its mission to protect consumers and give cosmetics manufacturers and distributors access to valuable information that supports the safety evaluation of ingredients.

Participation in the VCRP was a key component of the Personal Care Products Council’s (PCPC) Consumer Commitment Code. The enactment of MoCRA makes many of the industry’s voluntary activities mandatory, increases transparency and gives greater assurance to consumers that the products they trust and use every day are safe.