Comprender la normativa sobre cosméticos de la FDA: Guía para fabricantes de maquillaje

As a brand about to sell color cosmetics in the U.S. market, do you fully understand the potential impact of FDA cosmetic regulations on your products? For startups or brands looking to expand in the U.S. market, a deep understanding of these regulations may be the key to ensuring product compliance and commercial success.

As an expert with over ten years of experience in the cosmetics industry, I will provide a detailed analysis of FDA cosmetic regulations. I hope that through my insights, I can help you keep up with the latest regulatory developments.

This article will introduce the concept of cosmetics FDA in detail. You will learn the latest changes in these regulations and how to register with the FDA to help you understand the process and ensure product compliance and entry into the market.

Latest Updates on FDA Cosmetic Regulations in 2024

As a brand, keeping up to date with the latest updates to FDA cosmetic regulations is essential for compliance in the current industry. Here are some details on critical updates:

Ingredient Requirements

The new version of the cosmetic FDA certification requirements has stricter regulations on cosmeticmetics ingreosmetic ingredients must comply with FDA regulations, including banned and restricted ingredients. At the same time, additional ingredient requirements must be met for certain types of cosmetics, such as sunscreens, hair dyes, etc.

Safety Assessment Requirements

The new version of the cosmetic FDA certification requirements has stricter regulations on the safety assessment of cosmetics. Companies need to conduct a comprehensive safety assessment of their products, including ingredient safety, usage safety, etc. Scientific methods and procedures must be followed during the assessment process to ensure the accuracy and reliability of the assessment results.

Label Requirements

The new version of the cosmetic FDA certification requirements has stricter regulations on labeling cosmetics. Labels must be clear, accurate, and easy to understand, including product name, manufacturer information, usage instructions, ingredient list, etc. At the same time, labels must comply with FDA labeling specifications, such as font size, color, etc.

Adjustment of Voluntary Registration Program

The Voluntary Cosmetic Registration Program (VCRP) has been adjusted to simplify the registration process and strengthen the supervision of the market sales of unregistered products.

Manufacturer Requirements

The new version of the cosmetics FDA certification requirements has stricter regulations for cosmetics manufacturers. Manufacturers must have corresponding production capacity and quality management systems to ensure the quality and safety of products. At the same time, manufacturers must also comply with FDA regulations and requirements, such as reporting systems, record systems, etc.

What is FDA Cosmetic Registrations?

FDA (Food and Drug Administration) is the U.S. Food and Drug Administration responsible for regulating cosmetic products on the U.S. market. FDA registration for cosmetics is necessary to ensure product compliance and obtain market access.

According to the U.S. FDA cosmetic regulations, cosmetic companies can register cosmetics through the electronic system VCRP or submit paper documents before or after the product is launched in the United States. After registration, the company will have a registration number (registration number) and the product formula number (CPIS). The company must provide information, including company information (such as name, address, the person in charge, contact information, etc.) and product information (such as trademark, formula, raw material CAS number, etc.).

Scope of FDA Cosmetic Registrations

When cosmetics are exported to the United States or sold on platforms such as Amazon and eBay, companies may be required to register cosmetics. FDA registration is essential for all domestic and foreign companies that produce or sell food, drugs, medical devices, or cosmetics in the United States. The following are examples of company types that require FDA registration:

• Food Manufacturers, Processors and Packagers
• Drug Manufacturers, Packagers and Repackers
• Medical Device Manufacturers and Importers
• Cosmetic Manufacturers and Processors

Requirements for FDA Cosmetic Registrations

Product Responsible Person: During the FDA registration process for cosmetics, a responsible person in the United States must be appointed. This person will communicate and collaborate with the FDA and perform relevant obligations on behalf of the manufacturer.

Label and Ingredient Requirements: Cosmetics must comply with FDA regulations on labeling and ingredients. The product label should contain clear information such as the product name, net content, ingredient list, warnings, and instructions for use.

Safety Assessment: Cosmetics manufacturers need to conduct product safety assessments to ensure that the use of the product is harmless to the human body.

Manufacturer Registration: Manufacturers must complete registration in the FDA’s electronic registration system (Voluntary Cosmetic Registration Program, VCRP). During the registration process, relevant information, such as the manufacturer’s name, address, and contact information, needs to be provided.

Product Registration: Manufacturers must register each cosmetic product in the VCRP system. When registering, detailed information such as product name, brand, batch number, ingredient list, etc., must be provided, and photos of product labels must be uploaded.

Benefits of FDA Registration of Cosmetics

Obtain important information about cosmetic ingredients. FDA will enter all information obtained from VCRP into a computer database. Suppose a specific cosmetic ingredient is considered harmful and should be banned. In that case, the FDA will notify the manufacturer or seller of the product through the address book in the VCRP database.

If your product is not in the registration database, the FDA will not be able to notify you, avoiding product recalls or detentions during import due to ingredient problems.

If a cosmetic manufacturer files its product formula with VCRP, if the FDA finds that it uses unapproved color additives or other banned ingredients, it will remind the manufacturer to pay attention. In this way, the manufacturer can modify the product formula before the product is imported or sold, thereby eliminating the risk of product recalls or detentions due to improper use of ingredients. Help retailers identify safety-conscious manufacturers. Retailers (such as department stores) sometimes ask the FDA whether a cosmetic company has registered with the FDA.

Although registration does not mean FDA approval, it means that your product has been reviewed by the FDA and entered into the government database. If the product formula you submit is incomplete or contains a banned ingredient or unapproved color additive, FDA will notify you.

Five Categories of FDA Certification

The FDA certification we often talk about involves multiple fields, mainly including the following five categories:

The FDA divides food into two categories: registration and testing. For food, FDA registration is required, while products that come into contact with food need to undergo FDA food contact material testing.

For medical devices, FDA divides them into three categories: one is low-risk (such as glasses, band-aids, etc.), most of which are exempt from 510(k); the second category is general monitoring and special monitoring, most of which require pre-market 510(k), such as nitrile gloves, ear thermometers, wheelchairs, etc.; the third category requires pre-market approval (PMA), high risk (such as surgical lasers, PSA experiments, etc.).

Drugs are divided into human drugs and veterinary drugs. Currently, most functional daily chemical products (such as acne whitening masks, sunscreens, anti-wrinkle creams, anti-dandruff shampoos, antibacterial hand sanitizers, etc.) are classified as drugs by the FDA.

The FDA requires accession numbers for laser radiation electronic products before they can be exported to the United States. Before obtaining the Accession number, the product is usually tested to get the product’s IEC60825 laser radiation safety report.

For cosmetics (skin care products, makeup, perfume, etc.), the FDA has the latest regulatory requirements in 2023: According to the “Cosmetic Regulation Modernization Act of 2022” (MoCRA) signed and passed by U.S. President Biden on December 29, 2022, the US FDA stipulates that cosmetics exported to the United States must be registered with the FDA.

Precautions for FDA Cosmetic Registrations

Ensure Product Safety and Effectiveness

FDA cosmetics registration’s primary task is ensuring product safety and effectiveness. Companies need to ensure that the products’ ingredients are safe and harmless and provide correct usage methods and precautions in the instructions for use. In addition, companies need to conduct relevant clinical trials and safety assessments to ensure the effectiveness of the products.

Comply with labeling regulations

Labeling regulations are one of the essential aspects of FDA registration for cosmetics. Companies need to ensure that the labels of products are clear, easy to understand, and contain the necessary information, such as product name, ingredient list, instructions for use, etc. At the same time, they also need to follow the requirements of labeling regulations on ingredient identification, concentration identification, etc.

Submit registration information correctly

FDA registration of cosmetics requires the submission of a series of registration information, including basic information about the company, product information, ingredient list, instructions for use, etc. Companies need to ensure the authenticity and completeness of the information and submit the corresponding information as required. At the same time, they also need to pay attention to the format and submission method of the information and follow the relevant regulations of the FDA.

Pay Attention To The Registration Progress And Deal With Problems Promptly

During the FDA registration process of cosmetics, companies need to promptly pay attention to the registration progress and understand the review situation. If you encounter problems, you must quickly contact the FDA to solve them. At the same time, it is also necessary to comply with the relevant regulations of the FDA, such as paying the corresponding fees, providing necessary samples, etc.

Strengthen Internal Management and Training

FDA registration of cosmetics involves not only the product’s safety and compliance but also the enterprise’s internal management. Enterprises need to strengthen internal governance and training to ensure that employees understand the cosmetics regulations and standards and carry out production and quality control according to the requirements. At the same time, it is also necessary to establish a sound quality management system to ensure the safety and effectiveness of the product.

FDA Cosmetic Registrations Process

Understand Relevant Regulations And Standards

Before registering cosmetics with the FDA, companies need to understand the FDA’s relevant regulations and standards for cosmetics, including cosmetic and ingredient labeling regulations. These regulations and standards stipulate the requirements for the ingredients, labels, and safety of cosmetics to ensure the compliance and safety of the products.

Prepare Registration Materials

FDA registration for cosmetics requires submitting registration materials, including basic company information, product information, ingredient lists, instructions for use, etc. Companies must prepare these materials in advance and ensure their authenticity and completeness.

Submit Registration Application

Companies can register cosmetics with the FDA through the FDA’s electronic database or paper application. When applying, you need to pay the corresponding registration fee.

Review And Approval

FDA will review the submitted registration materials, including the approval of the product’s ingredient list and instructions for use, the review of the product label and operating instructions, etc. If the review is passed, the FDA will issue a registration certificate and announce the successful registration of the product with the FDA. If the review fails, it is necessary to modify and improve it according to the FDA’s feedback and resubmit the application.

FDA Cosmetic Registrations FAQ

1. Is there an official fee for cosmetics registration?
   The FDA does not charge an official fee
2. Does cosmetics registration include factory registration and product listing, and what numbers will be obtained after registration?
   It includes factory registration and product listing; from the current guidance documents, there should be two types of numbers: Facility Registration and Product Listing (similar to medical devices).
3. Is it required to sell more than $1,000 to register?
   There is no regulation.
4. Do you need to provide photos of product packaging and labels?
   Photos of packaging and labels are optional, and companies are advised to provide them.
5. Do you need to provide a complete ingredient list?
   It is required.
6. Can it be publicly queried after registration?
   Currently, it is not publicly queried

Resumen

FDA registration of cosmetics is one of the prerequisites to ensure that products can be sold in the U.S. market. By understanding the concept and registration steps of cosmetics FDA, you can ensure that your products meet the regulations and standards of the U.S. market and obtain compliance for market access. For personalized help to make your products FDA-compliant, please consider working with Xiran Cosméticos. Contact us now to keep you ahead in the evolving world of cosmetics.