Article**: Guantong Detection
1. Overview of FDA registration of cosmetics
FDA registration for cosmetics refers to the registration of companies that sell cosmetics in the United States in accordance with the requirements of the Federal Food and Drug Administration (FDA) to ensure the safety and compliance of products. Cosmetics FDA registration is designed to protect the health and safety of consumers, so it is crucial for businesses that want to sell cosmetics in the U.S. market to understand how to register with the cosmetics FDA and what to look out for.
The Cosmetics FDA is the highest level of regulatory agency in the United States and is responsible for ensuring the safety, efficacy, and quality of cosmetics. The scope of supervision includes, but is not limited to, the formulation, ingredients, labeling, production process and advertising of cosmetics. The goal of the Cosmetics FDA is to protect the health and rights of the public and ensure that cosmetics sold on the market comply with relevant regulations and standards.
2. FDA cosmetics registration review
Cosmetic ingredients must be approved by the FDA and labeled accordingly, a common practice for violating FDA regulations is to have improper ** requirements for cosmetic products, the distinction between cosmetic requirements and pharmaceutical requirements can be very subtle, and failure to understand these requirements can lead to enforcement actions by the FDA.
3. FDA registration review requirements
A cosmetics labeling specialist will first conduct an audit of your products to ensure that they meet the general requirements for packaging and labeling as defined by the U.S. Fair Packaging and Labeling Act (FPLA) and the Uniform Packaging and Labeling Regulation (UPLR). Other aspects of the review include:
Review each specific health-related or health-related claim to ensure that they do not fall within the class of drugs defined by the FDA drug regulations. We review all aspects of direct or indirect requests to see if they are substantiated and true, and provide explanations and recommendations for changes as needed.
4. The requirements for FDA registration and certification applications for cosmetics include the following aspects:
1. Ingredient declaration: The application for FDA registration and certification of cosmetics requires the submission of the ingredient declaration of the product, including all active ingredients, dyes, fragrances, etc. These ingredients must be legal and must not be harmful to the human body.
2. Safety statement: The application for FDA registration and certification of cosmetics needs to submit a safety statement of the product to prove that the product is safe under normal use conditions. This claim requires science-based trials and data.
3. Label statement: The application for FDA registration and certification of cosmetics needs to submit a label statement of the product, including the product name, manufacturer information, usage method, etc. Labels must be clear, unambiguous, and not misleading to consumers.
4. Compliance of the production process: The application for FDA registration and certification of cosmetics needs to prove that the production process of the product complies with the provisions of the FDA, including production equipment, sanitary conditions, quality control, etc.
5. Submit an application: The application for FDA registration and certification of cosmetics needs to be submitted through the FDA's ** application system, and the application fee varies according to the type and complexity of the product.
5. FDA registration process for cosmetics
Learn about regulations and standards.
Before registering with FDA for cosmetics, companies need to understand the relevant regulations and standards of FDA for cosmetics, including cosmetics labeling regulations, ingredient labeling regulations, etc. These regulations and standards specify the requirements for the ingredients, labeling, and safety of cosmetic products to ensure product compliance and safety.
Prepare registration materials.
For cosmetics FDA registration, you need to submit a series of registration materials to consult Besstone Testing for details, including basic information of the company, product information, ingredient list, instructions for use, etc. Enterprises need to prepare these materials in advance and ensure the authenticity and completeness of the materials.
Submit an application for registration.
Businesses can register with the FDA for cosmetics through the FDA's electronic database or paper applications. At the time of submitting the application, the corresponding registration fee needs to be paid.
Review and approval.
FDA will review the registration materials submitted, including the approval of the product's ingredient list and instructions for use, and the review of product labels and operating instructions. If the review is passed, FDA will issue a certificate of registration and announce the successful registration of the product with FDA. If the review is not approved, it needs to be revised and improved according to the feedback from the FDA, and the application needs to be resubmitted.
6. In October 2023, the new system of U.S. FDA cosmetics application and registration Q&A
1) Is there an official fee for cosmetics registration?
A: The FDA does not charge official fees.
2) Does the cosmetics registration include factory registration and product listing, and what numbers are obtained after the registration is completed?
A: Includes factory registration and product listing;Judging from the current guidance document, there should be two types of numbers: facility registration and product listing (very similar to medical devices).
3) Is there a requirement to sell more than $1,000 to register?
A: There are no rules.
4) Do you need to provide product packaging and labeling?
A: Packaging and labeling** are optional, not mandatory, and are recommended for enterprises.
5) Do I need to provide a complete ingredient list?
A: Yes.
6) Is it possible to make public inquiries after registration?
A: It is not available to the public at this time.
Basic conditions for FDA registration of cosmetics:
1.There are American** people.
2.Manufacturer or packer.
*Can a business do FDA registration?
*The cosmetics FDA registration of the ** merchant needs to provide the manufacturer itself before it can be registered.
Validity period of FDA registration for cosmetics:
It is valid for a long time and does not need to be renewed.
7. Benefits of FDA registration for cosmetics
1.To obtain important information about cosmetic ingredients, the FDA will enter all the information obtained from the VCRP into a computer database, and if a cosmetic ingredient currently in use is considered harmful and should be banned, the FDA will notify the manufacturer or seller of the product through the address book in the VCRP database.
2.If your product is no longer registered in the database, FDA will not be able to notify you to avoid a recall or detention at the time of importation due to an ingredient issue.
3.If a cosmetics manufacturer files a product formulation with the VCRP, the FDA will alert the manufacturer if it finds that the manufacturer has used unapproved color additives or other prohibited ingredients in the formulation, so that the manufacturer can modify the product formulation before the product is imported or sold, thereby eliminating the risk of product recall or detention due to the use of improper ingredients. Helping retailers identify safety-conscious manufacturers, retailers (e.g., department stores) sometimes ask the FDA if a cosmetics company is registered with the FDA.
4.While registration does not indicate FDA approval, it does indicate that your product has been reviewed by the FDA and entered into the ** database. FDA will notify you if you submit a product that is incomplete, or contains a prohibited ingredient or unapproved color additive.
By understanding the concept and registration steps of the Cosmetics FDA, you can ensure that your products meet the regulations and standards of the U.S. market and gain market entry compliance. Preparing the necessary documents and materials, conducting product label evaluations, creating an FDA e-portal account, submitting an application for registration, and waiting for FDA review and notification are the key steps in registering with the FDA for cosmetics. Please follow FDA guidelines and requirements to ensure product compliance and smooth access to the U.S. market.