Proregulations Streamlines the U.S. Cosmetic Registration Process
The FDA regulates cosmetics and their ingredients on the U.S. cosmetics market. Strict adherence to FDA regulations and standards is essential for the smooth entry and successful operation of cosmetic products on the US market. At Proregulations, a company that specializes in assisting with regulatory compliance, we offer U.S. Cosmetics Registration services designed to ensure that cosmetics meet U.S. regulatory requirements, reduce compliance risks, and expedite the product launch process.
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) further expands the FDA's regulatory authority over cosmetics and establishes a series of new requirements for the cosmetic industry, such as serious adverse event reporting obligations, facility registration, and product listing, etc. Proregulations has emphasized and thoroughly researched the U.S. cosmetic regulations, and has compiled the following highlights:
- Registration Number Application
The FDA Establishment Identifier (FEI) is an FDA system-generated number used to identify a company. To facilitate the registration process, the owner or operator of a cosmetic facility needs to obtain an FEI number prior to submitting the facility for registration.
- Facility Registration
With the exception of small businesses, manufacturers and processors of cosmetic products marketed in the U.S. must provide information to register their facilities with the FDA.
- Product Listing
With the enactment of MoCRA, cosmetics changed from voluntary to mandatory registration. Manufacturers, packagers, or distributors of cosmetic products are required to list each marketed cosmetic product, including the product's ingredients, with the FDA and update it annually.
- Cosmetics Direct Submission
Cosmetics Direct is the FDA's Structured Product Labeling (SPL) authoring tool for cosmetic facility registration and cosmetic product listing. Users can create and save SPL submissions, perform initial validation, and submit the SPL to the FDA for internal processing without the need for ESG.
With years of experience in cosmetic registration, Proregulations closely tracks the dynamics of U.S. cosmetic regulations and offers the following one-stop compliance services:
- MoCRA regulatory consulting and training
- Cosmetic facility registration
- Cosmetic product listing
- Cosmetic formulation and safety assessment
- Adverse event documentation and reporting
- Labelling compliance reviews
- FDA agent
For more information, please visit our website Proregulations-US FDA Cosmetics Registration.
About Proregulations
As a leading provider of product consulting and regulatory compliance solutions, Proregulations is committed to providing efficient and customized solutions to various industries around the globe, including regulatory interpretation, policy consultation, document preparation and submission. Our services are designed to help customers comply with local regulatory requirements, speed up product launches and improve market competitiveness. Our service areas range from chemicals, pharmaceuticals, medical devices, cosmetics, food & dietary supplements to agrochemicals & biocides. Our featured services include but are not limited to FDA Medical Device Registration, 510(k) Premarket Notification, Drug Master File Document, FDA ANDA, FDA NDA, IND Application, New Dietary Ingredients Compliance, FDA Agent Services, Medical Device Distributor License, TSCA Compliance, China Cosmetics Registration, etc.
Editor Details
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Company:
- Proregulations
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- Lisa Madison
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