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Expanding into the United States means more than launching a product—it means aligning with one of the most demanding regulatory systems in the cosmetics industry. Whether your product is classified as a cosmetic (MoCRA Act) or an OTC, full compliance with FDA requirements US Cosmetics Regulation is not optional.
At Cosmeservice, we guide you every step of the way from FDA MoCRA requirements to OTC registration, ensuring your brand enters the U.S. market legally and safely.
Contact UsThe United States Food and Drug Administration (FDA) plays a crucial role in overseeing US Cosmetics Regulation to ensure public safety. While the USA FDA does not approve cosmetic products before they reach the market, it enforces compliance through established regulatory frameworks and enforcement actions.
Understanding US Cosmetics Regulation is essential for both cosmetic manufacturers and consumers to ensure product safety and legal compliance.
Is your product subject to MoCRA, OTC or maybe both? At Cosmeservice, we guide you through the right US FDA compliance to ensure full compliance and a safe market launch.
MoCRA Act introduces mandatory requirements for cosmetics in United States. In effect since December 2023, MoCRA FDA introduces new mandatory requirements for cosmetic products in the US, including:
If your product makes therapeutic claims (such as treating acne, offering sun protection, or reducing dandruff), it may be regulated as an OTC rather than a cosmetic.
OTC FDA products must comply with:
Following Good Manufacturing Practices (GMP) is essential to ensure that your cosmetics are produced in a safe, clean, and controlled environment. While in US Cosmetics Regulation FDA does not mandate specific GMP regulations for cosmetics, adhering to US GMP standards helps brands minimize contamination risks, maintain product integrity, and enhance consumer trust.
By implementing best practices in manufacturing, quality control, and documentation, you can demonstrate compliance with industry standards, improve product safety, and strengthen your market position in the US cosmetics industry.
There is some key information that must appear in the packaging of the product such as name, identity, net quantity, direction of use, warnings, ingredients declaration. Our safety assessors will analyse and evaluate your products to inform you about any change or modifications that may apply.
The VCRP (Voluntary Cosmetic Registration Program) is no longer valid due to MoCRA FDA update. FDA is currently developing a new system for the mandatory notification and product listing to be used by manufacturers, packers, and distributors of cosmetic products that are in commercial distribution in the US.
California’s Proposition 65 requires cosmetic products to carry a warning label if they contain chemicals known to cause cancer, birth defects, or reproductive harm. These substances are listed by the Office of Environmental Health Hazard Assessment (OEHHA) and may be present in certain colorants, preservatives, or fragrances.
If the exposure to a listed chemical exceeds California’s safe harbor levels, a clear consumer warning must be provided on the product or its packaging. Ignoring this requirement can result in fines, lawsuits, or market withdrawal.
At Cosmeservice, we help you evaluate your formulas and ensure full compliance with Proposition 65 to avoid legal risks and protect your brand in the California market.
Washington State’s Toxic-Free Cosmetics Act, effective January 2025, bans the use of intentionally added toxic chemicals such as formaldehyde, PFAS, phthalates, and other harmful substances in Washington State cosmetics products.
This law reinforces the growing trend of state-level cosmetic ingredient restrictions in the U.S. To ensure full compliance, brands must monitor both federal and local legislation.
At Cosmeservice, we help you evaluate your formulations to avoid prohibited ingredients and adapt your compliance strategy to evolving state laws.
We don’t just help to comply with the compliance, we implement them for you. At Cosmeservice, our team of regulatory experts supports brands worldwide to:
In December 2022, the Congress approved the Modernization of Cosmetics Regulation Act (MoCRA), giving the FDA authority to create more strict US Cosmetics Regulation. The new MoCRA requires companies to register their manufacturing facility with the FDA and the Responsible Person to list (register) each cosmetic product sold in the American market.
An OTC (Over-The-Counter) product is a drug that can be sold without a prescription. In the US cosmetics regulation context, some products commonly marketed as cosmetics—such as sunscreens, antiperspirants, anti-acne treatments, or fluoride toothpastes—are classified as OTC drugs when they are intended to treat or prevent specific health conditions.
These products must comply with both cosmetic and drug regulations under the FDA, including adherence to monograph requirements, proper labeling, and pharmaceutical-grade GMP manufacturing standards.
At Cosmeservice, we help you determine whether your product qualifies as an OTC and ensure full compliance with US cosmetic and OTC regulations.
The definition of “Responsible Person” refers to the individual or entity that produces, packages, or distributes a cosmetic product and whose name is displayed on the product label as specified by section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act. The “responsible person” assumes responsibility for various tasks, including registering the cosmetic product, reporting adverse events, providing safety validation, creating labels, and maintaining documentation of fragrance allergen disclosures.
Cosmetic products must be safe for human use and properly labeled. They must also comply with US FDA regulations regarding the ingredients used in their manufacture.
The US FDA prohibits the use of certain ingredients in cosmetic products, including toxic substances such as lead and mercury, as well as certain chemicals that have been associated with health issues such as cancer or allergies.
The US FDA conducts inspections of cosmetic product manufacturing facilities and can order the removal of any product that does not meet its requirements from the market. It can also conduct laboratory testing to ensure that products meet safety standards.
Yes. Under the Modernization of Cosmetics Regulation Act (MoCRA), all foreign cosmetic manufacturers must designate a US Agent to legally market their products in the United States. The US Agent acts as the official point of contact between your company and the US FDA, handling communications, inspection requests, and regulatory updates.
At Cosmeservice, we offer a fully compliant U.S. Agent service to help you meet FDA requirements, including facility registration, product listing, and regulatory support throughout the process.
Yes, cosmetic products must be properly labeled with clear and accurate information about the ingredients and safety warnings.
If a cosmetic product does not meet FDA requirements, it can be removed from the market and manufacturers may face civil or criminal penalties.
No. While the US FDA provides the federal framework for cosmetic regulation in the US, individual states can enforce stricter requirements that go beyond national laws.
For example:
California enforces Proposition 65, requiring warning labels for products containing certain harmful chemicals.
Washington State has passed the Toxic-Free Cosmetics Act, banning specific ingredients starting in 2025.
New York and Maine have also introduced restrictions on substances like PFAS and require greater transparency in ingredient labeling.
Complying with federal laws does not guarantee full access to all state markets. At Cosmeservice, we guide you through both federal and state-level cosmetic compliance to ensure your products can be sold nationwide.
The PPWR Regulation is reshaping the rules, and early preparation makes compliance much easier.
With Cosmeservice you know exactly what to doand how to meet the deadline on time.
Get started today. Check your packaging compliance in less than a week.
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