U.S. Cosmetics Registration Guidance

1. Background Introduction

On December 29, 2022, U.S. President Joe Biden officially signed the Modernization of Cosmetics Regulation Act of 2022 (MoCRA), marking the most significant amendment to the Federal Food, Drug, and Cosmetic Act (FD&C Act) since 1938. The implementation of MoCRA signifies the modernization of the U.S. cosmetic regulatory framework, strengthening cosmetic product safety requirements and granting the U.S. Food and Drug Administration (FDA) enhanced regulatory authority.

Under MoCRA, cosmetic companies are required to register their facilities and list their products with the FDA, while ensuring product safety and compliance with Good Manufacturing Practices (GMP). In addition, companies must provide ingredient information, establish adverse event reporting systems, and adhere to more stringent labeling and marketing claim requirements. These new regulations aim to increase transparency in the cosmetics industry, enhance consumer confidence, and promote the industry's advancement toward higher standards.

This guidance document is intended to assist cosmetic companies in fully understanding and strictly complying with the regulatory requirements of MoCRA. It aims to ensure the legality and safety of products in the U.S. market, reduce compliance risks, enhance competitiveness in the international market, and promote sustainable industry development.

2. Definition of Cosmetics

The Federal Food, Drug & Cosmetic Act (FD&C Act) defines “cosmetic” in Section 201(i) as "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. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product. It does not include soap." MoCRA amends the FD&C Act to include “cosmetic product,” which is defined as “a preparation of cosmetic ingredients with a qualitatively and quantitatively set composition for use in a finished product” [FD&C Act, sec. 361].

3. Classification of Cosmetics

According to related laws, whether a product is a cosmetic or a drug under the law is determined by a product's intended use. Different laws and regulations apply to each type of product.

• Products intended for cleansing or beautifying are generally regulated as cosmetics. Examples include skin moisturizers, perfumes, lipsticks, nail polishes, makeup, shampoos, permanent waves, hair dyes, toothpastes, and deodorants.
• Products intended to treat or prevent disease, or to affect the structure or function of the body, are classified as drugs—even if they also affect appearance. Examples include treatments for dandruff or acne, sunscreen products, antiperspirants, and diaper rash ointments.
• Some products are both cosmetics and drugs and must comply with the requirements for both. Examples include fluoride toothpastes, anti-dandruff shampoos, antiperspirant deodorants, and moisturizers with SPF.
  

According to the Cosmetic Product Categories and Codes, from the Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products which is issued by Office of the Commissioner and Office of the Chief Scientist and aims at providing recommendations and instructions to assist persons submitting cosmetic product facility registrations and product listings to FDA, follows are the categories as well as codes of cosmetics.

4. Cosmetics Regulatory Authorities

In the United States, cosmetic regulation involves multiple agencies, primarily including the Food and Drug Administration (FDA) and its Office of Cosmetics and Colors (OCC), as well as the U.S. Customs and Border Protection (CBP). These agencies work collaboratively to ensure the safety and compliance of cosmetics on the U.S. market and to protect consumer rights.

• Food and Drug Administration (FDA): As the primary regulatory authority for cosmetics in the United States, the FDA is responsible for enforcing the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). Key responsibilities include developing and enforcing cosmetic regulations, overseeing product and ingredient safety, conducting market surveillance and enforcement as well as registering cosmetic facilities and businesses.
• Office of Cosmetics and Colors (OCC): As the dedicated division within the FDA responsible for cosmetics and color additives, the OCC’s key responsibilities include conducting cosmetic safety assessments as well as regulating color additives used in cosmetics.
• U.S. Customs and Border Protection (CBP): Responsible for overseeing imported cosmetics, the CBP’s main duties include inspecting imported cosmetic products as well as preventing non-compliant products from entering the U.S. market. 

5. Requirements for Placing Cosmetics on the U.S. Market

In the United States, the requirements for marketing cosmetics are primarily regulated by the Food and Drug Administration (FDA) and governed by the Federal Food, Drug, and Cosmetic Act (FD&C Act) as well as the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). MoCRA introduces more stringent regulatory requirements, enhancing transparency and oversight within the cosmetics industry.

Under the law, cosmetic products and their ingredients do not require premarket approval by the FDA, with the exception of color additives. However, the FDA has the authority to take enforcement action against products on the market that are non-compliant or against companies or individuals who violate the law. Generally, aside from color additives and substances explicitly prohibited or restricted by regulation, manufacturers may use any ingredient in cosmetic formulations, provided that:

• The ingredient and the finished product are safe for use under labeled or customary conditions of use;
• The product is properly labeled in accordance with applicable regulations; and
• The use of the ingredient does not render the cosmetic “adulterated” or “misbranded” under FDA-regulated laws.

The main requirements for marketing cosmetics in the U.S. market include:

• Facility registration
• Product listing
• Product safety substantiation
• Labeling compliance
• Good Manufacturing Practices (GMP)

Exemptions from cosmetic facility registration and product listing apply under the following two conditions: the business qualifies as a small business under FDA criteria or the facility solely manufactures or processes products regulated as drugs or medical devices. However, if the facility also manufactures products that are solely intended for use as cosmetics, registration is still required. For products that are both drugs and cosmetics, they are regulated as drugs, and submission of a cosmetic product listing is not required.

6. Responsibilities and Qualification Requirements for U.S. Agent

Under the FDA regulatory framework, U.S. cosmetic agents play a critical role. The FDA requires foreign companies to designate a U.S.-based agent. The U.S. agent must reside in the United States or maintain a physical place of business within the country. Serving as a liaison between the company and the FDA, the U.S. agent is essential for ensuring compliant market entry and ongoing regulatory oversight of cosmetic products.

The primary responsibilities of a U.S. agent include:

• Acting as the communication intermediary between the FDA and the facility, responsible for both emergency and routine communications;
• Receiving documents or information from the FDA on behalf of the company;
• Assisting the FDA in scheduling inspections of foreign facilities;
• Not responsible for adverse event reporting obligations.

7. Documentation Requirements for Cosmetics Registration

7.1 Facility Registration

All companies that market cosmetics in the United States are required to register their manufacturing or processing facilities with the FDA. The owner or operator of each such facility must complete the registration. The following information must be submitted:

• Name of the facility owner and/or operator;
• Facility name, physical manufacturing address, email address, and telephone number;
• For foreign cosmetic facilities: the name, telephone number, and email address (if available) of the U.S. agent for the facility;
• FEI (FDA Establishment Identifier) number — this must be obtained prior to submission;
• Brand names of all cosmetics manufactured or processed at the facility;
• Product categories and the responsible person for each cosmetic manufactured or processed at the facility;
• For each cosmetic product manufactured or processed at the facility: the product category and the corresponding responsible person.

Types of submission: initial, amendment, biennial renewal, or abbreviated renewal. Any changes to the submitted information (e.g., contact details, product categories, etc.) must be reported to the FDA within 60 days.

7.2 Product Listing

To complete cosmetic product listing, the following information must be prepared:

• FEI number of each facility where the cosmetic product is manufactured or processed. If the facility is exempt from registration and does not have an FEI number, the business name and address may be provided instead;
• Name and contact number of the responsible person, as well as the name of the cosmetic product (as it appears on the label);
• Cosmetic product category;
• List of product ingredients;
• Product listing number (if available).

Types of submission: initial, annual update or abbreviated update, including discontinuation information.

8. Testing Requirements for Cosmetics Registration

Under the Modernization of Cosmetics Regulation Act (MoCRA), the U.S. FDA does not mandate the submission of test reports during product listing. However, companies are required to ensure the safety of their cosmetic products. Below are the testing requirements and regulatory considerations regarding heavy metals, microbiological contamination, and animal testing.

8.1 Heavy Metals

For eye-area cosmetics containing mercury-based preservatives, the mercury content must not exceed 65 ppm. For all other cosmetic products, the mercury content should not exceed 1 ppm. Additionally, the lead content in lip products and externally applied cosmetics is recommended not to exceed 10 ppm. Companies should control heavy metal contamination through Good Manufacturing Practices (GMP) to ensure product safety.

8.2 Microbiological Contamination

Microbiological specifications and requirements are outlined in the 2021 Microbiology Guidelines published by the Personal Care Products Council (PCPC). These guidelines provide industry standards for controlling microbial contamination in cosmetic products.

8.3 Animal Testing

The U.S. FDA has not issued a federal regulation prohibiting animal testing for cosmetics. However, several states have enacted laws banning animal testing for cosmetic products, including New York, California, Nevada, Illinois, Hawaii, Maryland, Maine, New Jersey, Virginia, and Louisiana.

9. Cosmetics Registration Timeline

The key steps for cosmetic registration in the United States primarily include Facility Registration and Product Listing. These two processes are core compliance requirements under the Modernization of Cosmetics Regulation Act (MoCRA).

10. Post-Market Supervision Requirements for Cosmetics

The post-market surveillance of cosmetics in the United States is primarily overseen by the FDA (U.S. Food and Drug Administration), which ensures product safety and regulatory compliance. Key areas of oversight include product quality, ingredient safety, labeling compliance, and the monitoring and reporting of adverse events. Post-market oversight mainly involves FDA inspections and adverse event reporting.

10.1 FDA Inspections

FDA inspections primarily focus on two major concerns: adulteration and misbranding.

• A cosmetic may be considered adulterated if it contains harmful substances, is contaminated, or is manufactured under unsanitary conditions.
• A product may be deemed misbranded if its labeling is false, misleading, or fails to meet FDA labeling requirements.

The FDA has the authority to take enforcement actions such as issuing warning letters, requesting product recalls, or initiating legal proceedings against non-compliant products.

10.2 Adverse Event Reporting Requirements

Under the Modernization of Cosmetics Regulation Act (MoCRA), responsible persons are required to maintain records of adverse events and report serious adverse events to the FDA.

• Adverse Events: The responsible person must maintain records of all adverse events associated with the use of their cosmetic products, including both non-serious and serious adverse events. These records must be retained for six years. For small businesses, the retention period is three years.
• Serious Adverse Events: These include infections and serious disfigurement (such as severe and persistent rashes, second- or third-degree burns, significant hair loss, or substantial and lasting changes in appearance). The responsible person must report any serious adverse event occurring in the U.S. to the FDA within 15 business days, along with a copy of the product’s retail package labeling (outer and inner labels).

If the responsible person receives any new medical or other information related to the adverse event within one year after the initial report, they must submit this new information to the FDA within 15 business days. If the FDA has reasonable grounds to believe that a serious adverse event was caused by a fragrance or flavor, it may request the full list of ingredients in the cosmetic product. The responsible person must provide this information within 30 days.

Our Services

• The United States Agent
• The United States FDA Cosmetic Facility Registration
• The United States FDA Cosmetic Product Listing
• The United States FDA OTC Drug Registration
• The United States Color Additive Batch Certification
• The United States Cosmetic/OTC Drug Labeling Review
• International Cosmetic Ingredient Name (INCI) Application

If you need any assistance or have any questions, please get in touch with us via cosmetic@cirs-group.com.