June 20, 2025

The Modernization of Cosmetics Regulation Act (MoCRA) was enacted in December 2022, with full enforcement of core provisions beginning in 2024. MoCRA represents the most significant reform to cosmetic oversight in over 80 years, expanding the Food and Drug Administration’s (FDA) authority over cosmetic products and imposing mandatory requirements for facility registration, product listing, Good Manufacturing Practices (GMPs), adverse event reporting, and labeling. This regulatory overhaul affects the entire cosmetics supply chain, from brand owners and contract manufacturers to importers and distributors, requiring substantial updates to compliance and quality assurance systems to maintain market access in the U.S.

What is a Cosmetic?

The “cosmetic” product category covers a wide range of product types, including skin moisturizers, perfumes, lipsticks, fingernail polishes, makeup, cleansing shampoos, hair coloring, and deodorants, as well as any substance intended for use as a component of a cosmetic product. The main distinction between what the US FDA considers a cosmetic, rather than a drug or medical device, is that cosmetics are “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)]. Any product that falls into this definition is considered a cosmetic product by the FDA and is required to adhere to all regulations established in MoCRA. Some cosmetic products may also have formulations or labeling claims that would also classify them as a drug or a medical device. In these cases, the cosmetic would have to adhere to all applicable regulatory frameworks, in addition to MoCRA.

Cosmetics and drugs are governed by separate frameworks under the Federal Food, Drug, and Cosmetic (FD&C) Act. While cosmetics are intended for cleansing or enhancing appearance, drugs are used to diagnose, cure, mitigate, treat, or prevent disease. This distinction determines the regulatory pathway and level of oversight.

Products can fall into both categories if they serve dual purposes. For example, an antidandruff shampoo cleans hair (cosmetic) and treats dandruff (drug). Such hybrid products must meet the regulatory requirements of both product categories. However, regardless of whether a product is solely a cosmetic or also considered a drug, being classified as a cosmetic now carries specific obligations under MoCRA. The following sections outline the core requirements that all cosmetic products must meet to comply with federal regulations.

MoCRA requires all domestic and foreign facilities that manufacture or process cosmetics for U.S. distribution to register with the FDA. This applies to all facilities that manufacture or process cosmetics for U.S. distribution, including contract manufacturers and foreign producers. Retailers, salons, testing labs, and establishments only distributing finished products are not required to register. Facilities already in operation were originally expected to register by December 29, 2023; however, the FDA delayed enforcement, extending the deadline to July 1, 2024.

Following the July 1, 2024 deadline, any new facilities must complete their initial registration within 60 days of starting production and facilities must update their registration within 60 days of any changes. All registered facilities must renew their registration every two years to remain compliant.

Facility registrations include information such as facility name and address, contact information, what operations are conducted at the facility, and for foreign facilities, the U.S. agent that is authorized to act as the facility’s representative with the FDA.

Along with facility registration information, manufacturers must also submit product listings to the FDA regarding the products manufactured or processed at their facility. These listings include key data such as:

• Brand names

• Product categories

• Ingredient lists

This centralized data collection enables the FDA to monitor the market more effectively and respond swiftly to safety concerns. Failure to register a facility or properly list products may result in FDA enforcement actions, including warning letters, import alerts, product holds, or removal from the market.

Cosmetic manufacturers are now required to adhere to Good Manufacturing Practices (GMPs), marking a significant shift in how cosmetic products are regulated for quality and safety. These mandated practices establish a formal baseline for manufacturing standards designed to minimize contamination, ensure consistency, and protect consumers from substandard or potentially harmful products. GMPs cover critical areas of production, from facility operations to documentation and quality control, forming the foundation for product integrity across the supply chain. These practices encompass:

• Facility design and maintenance

• Sanitation protocols

• Raw material handling and storage

• Equipment cleanliness

• Documentation and batch control

Additionally, companies must maintain adequate substantiation of product safety. Acceptable evidence includes scientific data, studies, or evaluations by qualified experts that confirm a reasonable certainty of safety under labeled conditions of use. It is the responsibility of the manufacturer to determine and document whether appropriate safety substantiation has been achieved, and to ensure that the supporting evidence is both credible and sufficient. Proper safety substantiation is critical, as failure to demonstrate safety at the time of FDA audit may result in enforcement actions or removal from the market.

MoCRA introduces strengthened labeling requirements to enhance consumer understanding, support informed decision-making, and reduce the risk of product misuse. By standardizing what information must appear on cosmetic labels, the regulation aims to improve transparency across the industry while aligning U.S. practices more closely with international labeling standards. These updates are designed not only to promote safety and trust but also to minimize the potential for misbranding and regulatory violations. Manufacturers, packers, and distributors must ensure that product labels clearly communicate critical information to both regulators and end users.

Required label elements include:

• Product Identity: Clearly named function or purpose (e.g., shampoo, moisturizer)

• Net Quantity: Accurate volume or weight (e.g., 6 oz, 200 mL)

• Ingredient List: Ordered by predominance, on outer packaging

• Warnings: Specific warnings for products like hair dyes

• Usage Directions: Clear instructions for safe application

• Responsible Party: Name and contact details of manufacturer, packer, or distributor

• Fragrance Allergens: FDA will issue regulations requiring certain fragrance allergens to be identified on product labels, however, no final guidance on this requirement has been issued at this time.

To promote consumer safety and ensure swift regulatory response, MoCRA establishes comprehensive requirements for the monitoring, reporting, and documentation of adverse events related to cosmetic products. This framework is designed to improve post-market surveillance by mandating timely communication with the FDA and robust recordkeeping practices. By doing so, the regulation aims to quickly identify potential health risks associated with cosmetic products and facilitate appropriate interventions, thereby protecting public health and maintaining industry accountability.

• Serious Adverse Events: Must be reported to the FDA within 15 business days

• Record Retention: Maintain records for 6 years (or 3 years for small businesses)

• FDA Access: Full access to records is required if a product is suspected of posing a serious health risk

• Product Recalls: Although recalls remain voluntary, manufacturers are expected to take prompt action when safety issues arise.

MoCRA emphasizes the critical role of truthful, clear, and transparent communication in cosmetic product marketing to protect consumers from misleading or deceptive claims. Under the regulation, all advertising and promotional materials must align with both FDA regulations and Federal Trade Commission (FTC) standards, ensuring that marketing claims are substantiated by reliable evidence and that consumers receive accurate information about the products they use. This framework helps safeguard public trust by preventing false or unverified assertions, clarifying product benefits and limitations, and maintaining compliance with established labeling laws.

• Truthfulness: Claims like “wrinkle-reducing” must be evidence-based

• Prohibited Drug Claims: Products only classified as cosmetics cannot suggest they treat or cure medical conditions. Products that make these claims must also adhere to regulatory requirements governing drugs and/or medical devices

• Transparency: Accurate disclosure of ingredients, risks, and product limitations

• Labeling Laws: Adherence to the Fair Packaging and Labeling Act (FP&L Act) and FD&C Act is required

• Language Requirements: Labels must be in English unless marketed in a non-English-speaking territory; imported goods must state the country of origin

The Modernization of Cosmetics Regulation Act (MoCRA) of 2022 has fundamentally reshaped the regulatory landscape for cosmetics in the United States. With many core provisions already in effect and further refinements such as final guidance on fragrance allergens and GMP standards still expected, companies must treat compliance as an immediate and ongoing priority. Now is the time to audit current practices, ensure documentation is in order, and seek regulatory guidance where needed to stay ahead of enforcement and market expectations.

Beyond baseline compliance, businesses that take a proactive approach will be best positioned to adapt as new standards emerge, demonstrate product safety and quality to consumers, and maintain a competitive edge in both domestic and international markets. Regulatory preparedness is no longer optional, it is a strategic imperative. Partnering with experienced regulatory professionals can help ensure not just adherence, but long-term success in an evolving landscape.

Anand Bhati

Anand Bhati is a Regulatory Affairs Writer with experience in regulatory submissions, risk management, and global compliance for medical devices. He holds a Master’s in Regulatory Affairs from Northeastern University. His experience includes supporting 510(k) submissions, risk assessments, and regulatory strategy development for medical devices. He has contributed to post-market surveillance initiatives, clinical compliance tools, and vigilance reporting, ensuring adherence to FDA and international regulations. With a strong focus on cGMP compliance and quality systems, Anand is committed to regulatory excellence and facilitating market access for healthcare innovations.