(MODERNIZATION of COSMETIC REGULATIONS ACT)
How U.S. Law Defines Cosmetics
The Federal Food, Drug & Cosmetic Act defines cosmetics as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body…for cleansing, beautifying, promoting attractiveness, or altering the appearance.”
Included in this definition are products such as skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, shampoos, permanent waves, hair colors, toothpaste, and deodorants, as well as any material intended for use as a component of a cosmetic product.
With so much to consider, our expert FDA consultants will help you to navigate through the regulations you must be in compliance with.
What is MoCRA (Modernization of Cosmetics Regulation Act)?
Following the discontinuation of the Voluntary Cosmetic Registration Program (VCRP) in March 2023, the registration of cosmetic product facilities and product listing has become mandatory under MoCRA, the Modernization of Cosmetics Regulation Act.
MoCRA is set to take full effect on December 29, 2023.
Therefore, relevant stakeholders and businesses must plan and prepare for facility registration and product listing in advance.
The main factor of the legislation is to guarantee that manufacturers of cosmetic products provide reassurances regarding the safety of their products. They will need to meet certain requirements, such as:
Facility Registration: Cosmetic product manufacturers and processors must register their facilities with the FDA, update information within 60 days of any changes, and renew registration every two years.
Product Listing: A Responsible Person must list each cosmetic product being marketed with the FDA, including product ingredients, and update this information annually.
Responsible Person: The term "Responsible Person" refers to the cosmetic manufacturer, packer, or distributor whose name appears 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.
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, along with a copy of the label on or within the retail packaging of such cosmetic product, after receiving the report and certain additional information, such as new medical information, within 1 year of the initial report. FDA will also have access to adverse event reports during an inspection.
Safety Substantiation: Companies and individuals who manufacture or market cosmetics have a responsibility to ensure the safety of their products. Neither the law nor FDA regulations require specific tests to demonstrate the safety of individual products or ingredients.
Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products.
Among more of the regulations, there are two significant changes to the authority of the FDA:
Records Access: If certain conditions are met, FDA can access and copy certain records related to a cosmetic product, including safety records.
Mandatory Recall Authority: If the agency determines that 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.