About FDA and MOCRA

What is MoCRA?

​

According to the US FDA, MoCRA (Modernization of Cosmetics Regulation Act of 2022) “..is the most significant expansion of FDA’s authority to regulate cosmetics since the Federal Food, Drug, and Cosmetic (FD&C) Act was passed in 1938. This new law will help ensure the safety of cosmetic products many consumers use daily.”

​

For the first time, in line with other FDA regulated products like, food, drugs and medical devices, Cosmetics will be regulated in a similar fashion.

 

Here are some definitions to get you up to speed:

​

Facility: Any establishment (including an establishment of an importer) that manufactures or processes cosmetic products distributed in the United States.

​

Responsible Person: The manufacturer, packer, or distributor of a cosmetic product whose name appears on the label of a cosmetic product.

​

Adverse Event: Any health-related event associated with the use of a cosmetic product that is adverse, e.g. a non-fatal allergic reaction.

​

Serious Adverse Event: A health-related event that results in death or a life-threatening experience, hospitalization, significant disability or incapacity, birth defect, infection, disfigurement, or a surgical intervention (this list is non exhaustive).

 

MoCRA Gives FDA New Powers

​

This new law is comprehensive and gives FDA new powers which did not exist before including:

​

• Records Access - FDA can access and copy certain records related to a cosmetic product, including safety records.

​

• Mandatory Recall Authority – If there is a reasonable probability that a cosmetic is adulterated or misbranded and the use of or exposure to the cosmetic will cause serious adverse health consequences or death, FDA has the authority to order a mandatory recall if the responsible person refuses to do so voluntarily.

​

• Adverse Event Reporting - A responsible person is required to report serious adverse events associated with the use of cosmetic products in the United States to FDA within 15 business days.

​

• Facility Registration: Manufacturers and processors must register their facilities with FDA and renew their registration every two years. FDA may suspend registration if there is a reasonable probability of serious adverse events.

​

• Product Listing: A responsible person must list each marketed cosmetic product with FDA, including product ingredients, and provide any updates annually.

​

• Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products.

 

MoCRA Also Requires Compliance With:

​

• Good Manufacturing Practice for Manufacturers of cosmetic products.

• Fragrance allergen labelling.

• Standardized methods for identification of asbestos in talk containing products.

 

Exemptions: MoCRA exempts certain small businesses from GMP, registration, and product listing requirements. 

​

However, such exemptions do not apply to manufacturers or facilities that manufacture or process the following cosmetic products:

​

• Products that regularly come into contact with mucus membrane of the eye under customary or usual conditions of use.

• Products that are injected.

• Products that are intended for internal use.

• Products that are intended to alter appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions of use.

​

Exemptions also exist for certain products and facilities that are subject to requirements for drugs and devices.

​

MoCRA - What do i need to do?

​

Compliance Deadline: Originally, this was set to come into force on 29th December 2023 but has been delayed until July 1st 2024

​

What You Need to Do: If you wish to sell, or continue to sell, Cosmetics products in the US market, we advise to begin working on the following key tasks:

​​

• Identify Your Supply Chain: Know who all your ingredient manufacturers are and review the standards to which they operate. Ensure that you have up to date product specifications for all ingredients and know where they come from, how they are made and processed and that GMP is in place throughout the supply chain.

​

• Supplier and Raw Material Approvals: You will need to have stringent supplier and ingredient approval processes in place and gather certificates of analysis on a regular basis to ensure that your product(s) are safe and legal in the US. This is a key part of GMP requirements as is quality management and safety substantiation. You will be expected to keep records on all of these important safety aspects.

​

• Facility Registration and Listing: You will need to register the manufacturing facilities (or ensure that each manufacturer is registered) where required to ensure that FDA has visibility of who makes the finished product which is being marketed in the US.

​

• Safety Substantiation: The product specifications and safety substantiation information will need to be filed with FDA. There are not set tests on safety substantiation, and you can use existing information that is in the public or private domain for this, but it must be done and you must make sure that no unauthorized or illegal ingredients are used in your products. This must be documented and made available to FDA upon request.

​

Where you have a large list of cosmetic products that you currently sell, or plan to sell, in the US market the above requirements are not trivial.

​

We can help with MoCRA

​

We can help with all the above requirements to ensure that you are FDA Inspection ready. Using cloud technology, we have built a framework which allows you to automatically capture and process the information you will need to comply with MoCRA. We have designed this to be easy to use, affordable and robust and our team of compliance experts will be on hand to guide you as this new law evolves.