The United States remains a key market for cosmetics, attracting companies from around the world. But how can you comply with the 2025 regulatory requirements to succeed? Discover the essential steps to sell your products in full compliance.
Who regulates cosmetics in the U.S.?
The FDA (Food and Drug Administration) regulates cosmetic products in the United States at the national level, under the FD&C Act (Food, Drug, and Cosmetics Act). Since the introduction of MoCRA in 2022, the regulation of cosmetics has become stricter, with new requirements concerning product registration, ingredient safety, testing, and labeling.
In addition to federal rules, some states, such as California, Washington, Oregon, and Maryland, have additional laws, such as the California Safe Cosmetics Program (CSCP) and Toxic Free Cosmetics Acts, which complement those of the FDA. These state laws impose further requirements regarding ingredient safety, labeling, and traceability of cosmetic products, with a particular focus on eliminating toxic substances and potentially harmful chemicals in cosmetics.
Definition of a cosmetic product
What is a cosmetic product? The exact definition can vary from one country to another, which can have a significant impact on the regulation of your product. In the U.S., you need to verify whether your product is considered a cosmetic, an OTC (Over-The-Counter) product, or even a medical device!
> To know the difference between an OTC or a cosmetic, read this article! <
The FD&C Act defines cosmetics as "articles intended to be applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance."
10 Things to Know About Cosmetics Regulation in the United States
- 1/ Product Registration is Required Within 120 Days:
Under MoCRA, cosmetic products must now be registered with the FDA. Products must be registered within 120 days of being placed on the market. This includes information on the products, ingredients, and safety tests. Registration allows the FDA to track products and ensure compliance.
- 2/ Safety Assessment is Critical:
It is now imperative to prove that your cosmetic products are safe before being placed on the market. MoCRA imposes rigorous safety assessments on ingredients and finished products before they are marketed. You will need to provide data on the safety of your products if inspected by the FDA.
- 3/ Safety Testing May Be Required:
The FDA does not impose a precise list of tests, but companies must perform tests to ensure product safety. MoCRA strengthens this requirement by allowing the FDA to request additional tests to ensure the safety of cosmetic products.
- 4/ Altered Cosmetics Are Prohibited:
A product is considered "altered" if its composition violates rules due to ingredients, processing, packaging, shipping, or handling. MoCRA has reinforced these requirements to prohibit products containing toxic substances or those manufactured under unsanitary conditions.
- 5/ FDA Enforcement and Control Measures Are Strengthened:
If a product is mislabeled or falsified, the FDA can now seize products, order recalls, or issue public safety notifications. In case of non-compliance, the FDA can also work with customs to prevent non-compliant products from entering the market.
- 6/ / Label and Claim Review is Essential:
Cosmetic product labeling must comply with FDA requirements and the Fair Packaging and Labeling Act (FPLA). According to MoCRA, labeling must be more precise, especially regarding ingredient safety and product compliance, to protect consumers and ensure transparency. Since MoCRA, cosmetic products intended exclusively for professionals must be clearly identified as such on the label to prevent their use by untrained consumers.
Cosmetic claims are also strictly controlled, and MoCRA has strengthened this oversight. For example, a product claiming to eliminate wrinkles could be classified as a drug if the claim affects the structure of the skin. All claims must be verified and backed by scientific evidence to avoid deception.
- 7/ The Importance of an US Agent for International Companies:
Since the introduction of MoCRA, foreign companies wishing to sell their cosmetic products in the United States must designate an US Agent. This representative is responsible for communicating with the FDA and ensuring all U.S. regulatory requirements are met, including product registration and compliance with safety testing.
The role of the US Agent is crucial for:
- Facilitating product registration with the FDA.
- Assisting with inspections and required documentation by the FDA.
- Acting as an intermediary for any necessary communication between the FDA and the foreign company.
This not only ensures compliance with FDA requirements but also makes the market entry smoother for international businesses. If you are a foreign company, appointing a reliable US Agent is an essential step to ensure your cosmetic products meet all legal requirements in the United States.
- 8/ Color Additives Must Be Approved by the FDA:
All color additives used in cosmetic products must be approved by the FDA before use. MoCRA also emphasizes the need for color additives to comply with concentration and safety standards.
- 9/ You Must Follow Good Manufacturing Practices (GMP):
MoCRA emphasizes the importance of following Good Manufacturing Practices (GMP). Manufacturers must adhere to guidelines regarding production, equipment, personnel management, and raw material quality to ensure the safety and efficacy of cosmetic products. However, although the FDA was expected to release GMP guidelines by the end of 2024, these are still awaited due to the current political situation. In the meantime, companies must prepare to adopt manufacturing practices in line with the expected quality and safety standards once the GMPs are published.
- 10/ Allergens Must Be Considered:
The FDA was supposed to publish an official list of allergens to be labeled by June 2024, but this publication is still pending in 2025 due to the current situation. In the meantime, it is essential for manufacturers to remain vigilant and include information on known and potentially problematic allergens in the labeling of their cosmetic products, following best practices and current regulations.
Get Advice from Regulatory Experts!
Finally, the best way to ensure your products comply with U.S. regulations is to work with a local regulatory partner. Whether you are an American or international company, FDA principles can be difficult to follow, and it can be even more challenging to comply with local regulations in the states where you intend to sell your products.
Our North American regulatory experts are well-versed in U.S. cosmetics regulations and have 15 years of experience in this market. They can assist you with:
- Safety assessments
- Product registration
- Label and claim reviews
- Verifying color additive compliance
- Reviewing your product portfolio (OTC, cosmetics, medical devices?)
- Acting as your US Agent
👉 EcoMundo already supports over 500 clients worldwide. Feel free to contact us to ensure your compliance with FDA requirements and stay informed about the latest regulatory developments.
The United States remains a key market for cosmetics, attracting companies from around the world. But how can you comply with the 2025 regulatory requirements to succeed? Discover the essential steps to sell your products in full compliance.
Who regulates cosmetics in the U.S.?
The FDA (Food and Drug Administration) regulates cosmetic products in the United States at the national level, under the FD&C Act (Food, Drug, and Cosmetics Act). Since the introduction of MoCRA in 2022, the regulation of cosmetics has become stricter, with new requirements concerning product registration, ingredient safety, testing, and labeling.
In addition to federal rules, some states, such as California, Washington, Oregon, and Maryland, have additional laws, such as the California Safe Cosmetics Program (CSCP) and Toxic Free Cosmetics Acts, which complement those of the FDA. These state laws impose further requirements regarding ingredient safety, labeling, and traceability of cosmetic products, with a particular focus on eliminating toxic substances and potentially harmful chemicals in cosmetics.
Definition of a cosmetic product
What is a cosmetic product? The exact definition can vary from one country to another, which can have a significant impact on the regulation of your product. In the U.S., you need to verify whether your product is considered a cosmetic, an OTC (Over-The-Counter) product, or even a medical device!
> To know the difference between an OTC or a cosmetic, read this article! <
The FD&C Act defines cosmetics as "articles intended to be applied to the human body... for cleansing, beautifying, promoting attractiveness, or altering the appearance."
10 Things to Know About Cosmetics Regulation in the United States
- 1/ Product Registration is Required Within 120 Days:
Under MoCRA, cosmetic products must now be registered with the FDA. Products must be registered within 120 days of being placed on the market. This includes information on the products, ingredients, and safety tests. Registration allows the FDA to track products and ensure compliance.
- 2/ Safety Assessment is Critical:
It is now imperative to prove that your cosmetic products are safe before being placed on the market. MoCRA imposes rigorous safety assessments on ingredients and finished products before they are marketed. You will need to provide data on the safety of your products if inspected by the FDA.
- 3/ Safety Testing May Be Required:
The FDA does not impose a precise list of tests, but companies must perform tests to ensure product safety. MoCRA strengthens this requirement by allowing the FDA to request additional tests to ensure the safety of cosmetic products.
- 4/ Altered Cosmetics Are Prohibited:
A product is considered "altered" if its composition violates rules due to ingredients, processing, packaging, shipping, or handling. MoCRA has reinforced these requirements to prohibit products containing toxic substances or those manufactured under unsanitary conditions.
- 5/ FDA Enforcement and Control Measures Are Strengthened:
If a product is mislabeled or falsified, the FDA can now seize products, order recalls, or issue public safety notifications. In case of non-compliance, the FDA can also work with customs to prevent non-compliant products from entering the market.
- 6/ / Label and Claim Review is Essential:
Cosmetic product labeling must comply with FDA requirements and the Fair Packaging and Labeling Act (FPLA). According to MoCRA, labeling must be more precise, especially regarding ingredient safety and product compliance, to protect consumers and ensure transparency. Since MoCRA, cosmetic products intended exclusively for professionals must be clearly identified as such on the label to prevent their use by untrained consumers.
Cosmetic claims are also strictly controlled, and MoCRA has strengthened this oversight. For example, a product claiming to eliminate wrinkles could be classified as a drug if the claim affects the structure of the skin. All claims must be verified and backed by scientific evidence to avoid deception.
- 7/ The Importance of an US Agent for International Companies:
Since the introduction of MoCRA, foreign companies wishing to sell their cosmetic products in the United States must designate an US Agent. This representative is responsible for communicating with the FDA and ensuring all U.S. regulatory requirements are met, including product registration and compliance with safety testing.
The role of the US Agent is crucial for:
- Facilitating product registration with the FDA.
- Assisting with inspections and required documentation by the FDA.
- Acting as an intermediary for any necessary communication between the FDA and the foreign company.
This not only ensures compliance with FDA requirements but also makes the market entry smoother for international businesses. If you are a foreign company, appointing a reliable US Agent is an essential step to ensure your cosmetic products meet all legal requirements in the United States.
- 8/ Color Additives Must Be Approved by the FDA:
All color additives used in cosmetic products must be approved by the FDA before use. MoCRA also emphasizes the need for color additives to comply with concentration and safety standards.
- 9/ You Must Follow Good Manufacturing Practices (GMP):
MoCRA emphasizes the importance of following Good Manufacturing Practices (GMP). Manufacturers must adhere to guidelines regarding production, equipment, personnel management, and raw material quality to ensure the safety and efficacy of cosmetic products. However, although the FDA was expected to release GMP guidelines by the end of 2024, these are still awaited due to the current political situation. In the meantime, companies must prepare to adopt manufacturing practices in line with the expected quality and safety standards once the GMPs are published.
- 10/ Allergens Must Be Considered:
The FDA was supposed to publish an official list of allergens to be labeled by June 2024, but this publication is still pending in 2025 due to the current situation. In the meantime, it is essential for manufacturers to remain vigilant and include information on known and potentially problematic allergens in the labeling of their cosmetic products, following best practices and current regulations.
Get Advice from Regulatory Experts!
Finally, the best way to ensure your products comply with U.S. regulations is to work with a local regulatory partner. Whether you are an American or international company, FDA principles can be difficult to follow, and it can be even more challenging to comply with local regulations in the states where you intend to sell your products.
Our North American regulatory experts are well-versed in U.S. cosmetics regulations and have 15 years of experience in this market. They can assist you with:
- Safety assessments
- Product registration
- Label and claim reviews
- Verifying color additive compliance
- Reviewing your product portfolio (OTC, cosmetics, medical devices?)
- Acting as your US Agent
👉 EcoMundo already supports over 500 clients worldwide. Feel free to contact us to ensure your compliance with FDA requirements and stay informed about the latest regulatory developments.
