In a groundbreaking move aimed at enhancing consumer safety and transparency, the United States is set to implement comprehensive changes to cosmetic regulations starting in 2024.
These transformative regulations will redefine the landscape for all cosmetic products, including manufacturing and labeling. Continue reading and we will provide you with the details about these new regulations:
1) The "Responsible Person" & Facility Registration:
An owner or operator of an existing facility that manufactures or processes cosmetic products for U.S. distribution must now register with FDA, whether the facility is located in the United States or abroad. Registration will involve providing certain prescribed information to FDA, such as all brand names under which the cosmetic products manufactured or processed in the facility are sold, the product category or categories, and the identity of a Responsible Person
The term "Responsible Person" refers to the cosmetic manufacturer, packer, or distributor whose name must appear on the label of a cosmetic product as required by section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.
2) New Labeling Requirements:
The updated labeling requirements will focus on providing consumers with clearer and more detailed information about the products they use. This includes comprehensive ingredient lists, allergen warnings, and explicit instructions for use. The aim is to empower consumers to make informed choices about the products they incorporate into their beauty routines.
3) Mandatory Product Listing and Facility Registration
This means that manufacturers will be required to provide detailed information about the products they produce, including ingredients and formulations, and register their facilities with the relevant authorities. This measure aims to create a more transparent supply chain and facilitate quicker responses in the event of safety concerns.
4) Reporting of Serious Adverse Events
In a move toward proactive consumer protection, the new regulations will mandate the reporting of serious adverse events related to cosmetic products. Manufacturers and responsible persons will be required to promptly report any adverse reactions or safety concerns associated with their products. This reporting mechanism is designed to enable regulatory bodies to swiftly address potential risks and take appropriate measures to protect consumers.
5) Finished Product Safety Assessment:
Under the updated regulations, cosmetic products will be subject to a rigorous safety assessment before entering the market. This assessment will evaluate the safety of the finished product, taking into account its ingredients, formulation, and intended use. The goal is to prevent the sale of products that may pose a risk to consumers, reinforcing the commitment to consumer safety within the cosmetic industry.
6) Establishment of a New Good Manufacturing Practice Standard:
This standard will outline the best practices and quality control measures that manufacturers must adhere to, ensuring that cosmetic products meet the highest standards of safety and quality.
The MoCRA is set to take full effect on December 29, 2023. It represents the most significant expansion of the FDA’s authority to regulate cosmetics since the passage of the Federal Food, Drug, and Cosmetic (FD&C) Act in 1938.
The FDA has announced a six-month postponement in enforcing the registration of cosmetic product facilities and the listing of cosmetic products, extending beyond the initial deadline of December 29, 2023, until July 1, 2024. This extension allows industries additional time to ensure compliance. Specifically, the FDA will not enforce registration for facilities that started manufacturing or processing cosmetic products after December 29, 2022, nor the listing requirement for cosmetic products introduced to the market after the same date until July 1, 2024.
Importantly, despite the delay in enforcing Facility Registration and Product Listing requirements, all other statutory obligations scheduled for implementation on December 29, 2023, remain unaffected. From adverse event tracking and reporting, Safety substantiation, Professional use labeling, and Records access.
If you want to stay informed of any variation of these regulations, you can access the FDA's official guidance by clicking here.
