The United States is a vast and lucrative cosmetics market with an annual consumption potential reaching hundreds of billions of dollars. To penetrate this market successfully, cosmetics businesses must adhere to the stringent regulations set by the U.S. Food and Drug Administration (FDA). Among these, FDA registration is a mandatory requirement for all cosmetic products seeking circulation in the U.S.

So, what is FDA registration for cosmetics? How can one achieve this registration? The following article aims to provide you with detailed answers to these questions!

1. What is FDA cosmetic registration?

The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) represents a substantial broadening of the FDA’s regulatory authority over cosmetics, marking the most significant development since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938. This recent legislation is aimed at enhancing the safety of cosmetic products that numerous consumers incorporate into their daily routines.

The FDA cosmetics registration refers to the strict regulations established by the U.S. Food and Drug Administration (FDA) to ensure the safety of cosmetic products falling within the regulated categories and circulating in the U.S. market. Any exporter intending to import cosmetics into the United States must ensure that the products comply with FDA regulations regarding safety and labeling. Adhering to these regulations will help ensure consumer safety and enhance the reputation of the cosmetic business.

2. What is the role of the FDA cosmetics regulation?

The U.S. Food and Drug Administration (FDA) is a federal agency responsible for safeguarding public health by overseeing and regulating food, pharmaceuticals, medical devices, vaccines, and other products. In the cosmetic industry, the FDA plays a crucial role in ensuring consumer safety. Specifically, the FDA performs the following tasks:

• Issuing Cosmetic Regulations: FDA establishes regulations for cosmetics, including requirements for ingredients, labeling, and manufacturing.
• Monitoring Compliance: FDA monitors the implementation of cosmetic regulations to ensure industry-wide adherence.
• Enforcing Violations: The FDA takes action against cosmetic-related violations to uphold safety standards.

FDA regulations for cosmetics encompass:

• Ingredient Requirements: Clear guidelines on permitted cosmetic ingredients and maximum concentrations for each component.
• Labeling Requirements: Regulations on the content and format of cosmetic product labels, including product names, ingredients, and usage instructions.
• Manufacturing Requirements: FDA sets standards for quality management systems, production conditions, storage, etc., for cosmetic manufacturing facilities.

The FDA conducts oversight of cosmetic regulations through various means, including:

• Market Surveillance: Examination of cosmetic products available in the market to verify adherence to regulatory standards.
• Receipt and Handling of Reports: Reception and processing of reports regarding unsafe cosmetic products.

The FDA has the authority to address cosmetic violations through actions such as:

• Product Recall Orders: Ordering the recall of non-compliant products from the market.
• Manufacturing, Import, or Distribution Bans: Imposing bans on the production, import, or distribution of specific products.
• Monetary Penalties: Issuing fines for violations.

The FDA’s role in cosmetic management significantly contributes to safeguarding public health. FDA cosmetic registration is a crucial factor for cosmetic businesses to affirm the credibility and quality of their products, instilling confidence in consumers.

3. How to register and obtain FDA for cosmetics

To obtain FDA registration for cosmetics, businesses must meet the following conditions:

• All cosmetic manufacturing and processing facilities targeting the U.S. market must register with the U.S. Food and Drug Administration (FDA), regardless of whether the facility is located within the United States. The exemption from this requirement applies solely to companies engaged solely in labeling, relabeling, packaging, repackaging, holding, and/or distributing cosmetic products.
• U.S. cosmetic manufacturers, packagers, and distributors are required to list their products with the FDA. The necessary information for listing includes details such as product ingredients, fragrance, colors, place of manufacture, contact information, etc. The responsible person can receive reports of adverse effects associated with the product.
• The new labeling requirements include listing allergens and contact information on the product label or packaging to allow consumers to report product side effects. Additionally, the FDA requires labeling that states “Professional Use Only” to indicate that the product is intended for professional use and not for consumer use at home.

Registration Documentation:

3.1 Business Information:

Business name, main office address, contact information, business field, and details of the cosmetic products intended for export to the U.S.

3.2 Product Information:

Product name, ingredients, product labeling, manufacturing information.

3.3 Registration Procedure:

To conduct business in the U.S., many foreign companies are required to register a U.S representative office. GOL can help streamline the process with expertise and support. GOL is your trusted partner for exporting to the United States, which helps you navigate the complex regulatory landscape and ensure that your products meet all U.S. requirements. GOL’s team of experts can help you with everything from product compliance to customs clearance.

3.4 Submission of Product Registration Documentation:

Product registration documentation should be sent to the FDA via mail or online submission.

4.  Is FDA cosmetic registration mandatory?

According to the 2022 Modernization of Cosmetic Regulations Act (MoCRA) in the United States, registering cosmetic manufacturing facilities and listing cosmetic products is mandatory for certain specific businesses. This represents a significant change from the previous Voluntary Cosmetic Registration Program.

Under MoCRA, registration of facilities is compulsory for:

• Manufacturers and processors of commercial cosmetics.
• Facilities engaged in packaging and labeling cosmetics under contract.
• Other facilities that store or distribute cosmetics in commerce

Effective Date:

• For businesses engaged in manufacturing and distribution activities before December 29, 2022, registration must be completed by December 29, 2023. The FDA provides a 6-month period for businesses to finalize their registration documents with the FDA.
• For businesses commencing operations after December 29, 2023, the FDA allows a 60-day window from the start of operations or until April 27, 2024, for businesses to complete their registration documents with the FDA.

Exemptions apply to:

Small businesses with a continuous revenue below 1 million USD over three years are exempt from registration, except for certain specified products.

For these specific types of cosmetic products, not obtaining FDA registration may lead to the FDA recalling the products from the market. It’s crucial for businesses to be aware of these requirements and ensure compliance to avoid regulatory actions by the FDA.

Obtaining FDA registration for cosmetics brings several advantages for businesses, including:

• Ensuring Consumer Safety: registration ensures that cosmetic products meet safety standards, providing consumers with confidence in the products they use.
• Enhancing Business Credibility: FDA registration adds credibility to the business, signaling a commitment to quality and safety.
• Gaining a Competitive Edge: Certified cosmetics stand out in the market, giving businesses a competitive advantage by demonstrating adherence to regulatory standards.

Considering these benefits, cosmetic manufacturers and businesses should seriously consider registering for FDA registration for their products, even when it’s not mandatory.

5. Reliable FDA registration company 

Navigating the intricate process of FDA registration can be a daunting task for most businesses. Recognizing the complexity involved, many opt for the wise decision of seeking FDA registration services to alleviate the burden and ensure a smooth procedure. Reputable companies like GOL provide peace of mind and efficiency for businesses, saving them time and effort in complying with FDA standards and regulations.GOL is a professional consulting firm specializing in FDA registration services for Vietnamese businesses looking to export cosmetics to the U.S. With over a decade of experience in the field, GOL has assisted thousands of businesses in swiftly and conveniently obtaining FDA registration for their products.

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