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USA Cosmetic Regulations
US Cosmetic Compliance under FDA
United States FDA Cosmetic Compliance
USA Cosmetic Regulations: MoCRA & OTC Compliance
Expanding into the United States means more than launching a product. In fact, it means meeting USA Cosmetic Regulations, one of the most demanding regulatory systems in the cosmetics industry. Whether your product is a cosmetic (MoCRA Act) or an OTC drug, full compliance with FDA requirements is not optional.
At Cosmeservice, we guide you every step of the way, from FDA MoCRA requirements to OTC registration. As a result, your brand enters the US market legally and safely.
Contact UsUnderstanding USA Cosmetic Regulations and the FDA
The US Food and Drug Administration (FDA) oversees USA Cosmetic Regulations to protect public safety. The FDA does not approve cosmetic products before they reach the market. However, it enforces compliance through regulatory frameworks and enforcement actions.
For this reason, both manufacturers and consumers need to understand these rules to ensure product safety and legal compliance.
Explore our US Cosmetics Compliance Services
Is your product subject to MoCRA, OTC or maybe both? At Cosmeservice, we guide you through the right FDA pathway. That way, you 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:
- Facility registration (from July 2024)
- Product listing
- Safety substantiation
- Serious adverse event reporting
- Updated labeling requirements
- Compliance with cosmetic GMP (from December 2025)
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:
- Applicable FDA monograph
- Drug Facts labeling format
- Drug GMP requirements (21 CFR Part 211)
- Possible SPL submissions to the FDA
USA Cosmetic Regulations: GMP, Labeling & State Laws
Following Good Manufacturing Practices (GMP) helps you produce cosmetics in a safe, clean and controlled environment. Currently, the FDA does not mandate specific GMP rules for cosmetics. Even so, following US GMP standards helps brands minimize contamination risks, maintain product integrity and build consumer trust.
In addition, best practices in manufacturing, quality control and documentation demonstrate compliance with industry standards. As a result, you improve product safety and strengthen your position in the US cosmetics market.
Under USA Cosmetic Regulations, the packaging must show key information. This includes the product name and identity, net quantity, directions for use, warnings and the ingredient declaration. Our safety assessors analyze your products and, if needed, let you know about any required changes.
Since MoCRA FDA update, the VCRP (Voluntary Cosmetic Registration Program) is no longer in use. 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 a warning label on cosmetics with chemicals linked to cancer, birth defects or reproductive harm. The Office of Environmental Health Hazard Assessment (OEHHA) lists these substances, which may appear in some colorants, preservatives or fragrances.
If exposure to a listed chemical exceeds California’s safe harbor levels, the product or its packaging must carry a clear consumer warning. Otherwise, brands risk 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 took effect in January 2025. It bans intentionally added toxic chemicals in cosmetics, such as formaldehyde, PFAS and phthalates, among other harmful substances.
This law reflects a growing trend of state-level cosmetic ingredient restrictions in the US. Therefore, brands must monitor both federal and state legislation to stay compliant.
At Cosmeservice, we help you evaluate your formulations to avoid prohibited ingredients. Moreover, we adapt your compliance strategy as state laws evolve.
Choose Cosmeservice as your US Compliance Partner
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:
- Identify the right compliance pathway (Cosmetics or OTC)
- FDA MoCRA registration and product listing
- Act as your US Agent and RP Support for FDA compliance
- Strategic, personalized guidance
FAQS
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.
