According to industry data, by 2021, the United States will become the world's largest consumer of cosmetics, accounting for about 19.99% of the global market. . The US market is fertile ground, the cosmetics market is worth $100 billion. It is also my country's largest cosmetics export destination. It is the preferred overseas market for domestic enterprises and a must-see for cosmetics manufacturers. Strengthen the supervision of the cosmetics industry to protect the rights and interests of consumers.
Cosmetics Modernization Act ( as part of the Omnibus Act 2023. Museum of Modern Art & #41. Enacted on December 29, 2022, this is a major overhaul of FDA's current regulatory framework for cosmetics.
MoCRA amends the Federal Food, Drug, and Cosmetic Act. French Ministry of Defense 41. Chapter V includes new provisions for cosmetics. These rules give FDA important new powers and strengthen FDA's regulation of cosmetics for the first time since the FDCA was enacted in 1938. Although the new regulations do not include post-launch approval requirements for cosmetic products, compared with the previous ones, the new regulations impose some new obligations on the cosmetics industry.
Owners and operators of cosmetic manufacturing or processing facilities must now register with FDA and renew their registration every two years. . Notably, unlike the requirements for food and dietary supplement manufacturers, manufacturer facilities that conduct activities solely related to cosmetic labeling, relabelling, packaging, repackaging, possession, and/or distribution do not need to register.
A "responsible person" (such as the cosmetic manufacturer, packer, or distributor whose name appears on the label) must list each of its cosmetic products with FDA, including the contact information of a person who can receive adverse event reports.
Mandatory adverse event reporting.
The responsible person is obliged to submit a serious adverse event report to FDA within 15 days of receiving the serious adverse event feedback and to keep all records related to the serious adverse event for at least 6 years, similar to the adverse event reporting requirements for dietary supplements and over-the-counter drugs. Unlike other products regulated by the FDA, for cosmetic products, MocRA provides specific details of what constitutes a reported event, including an infection or a "major defect" such as "severe and persistent rash, second- or third-degree burns, severe hair loss, or Under normal conditions of use, there is a permanent or significant change in appearance than expected
Responsible persons will be required to keep records to support "sufficient evidence" of the cosmetics' safety. Cosmetics without adequate safety certification will be considered adulterated under the FDCA's new adulteration testing standards.
Current Good Manufacturing Practices for Cosmetics
The FDA has issued mandatory current good manufacturing practices for cosmetics (. GMP & #41. Regulations comply with national and international standards.
Mandatory allergen labeling.
MoCRA requires FDA to adopt regulations to identify fragrance allergens that must be disclosed on cosmetic labels. This labeling requirement applies regardless of whether the cosmetic product is subject to drug or device regulations.
MoCRA authorizes FDA to order a mandatory recall of this cosmetic product if it determines that the cosmetic product may cause serious adverse health consequences or death.
Collectively, these rules bring FDA's regulation of cosmetics more in line with its regulation of other products.
Cosmetic business registration, product filing and new enforcement regulations will take effect one year after the legislation is enacted. Judging from the content of the regulations, the FDA's supervision has also changed from the previous voluntary registration to mandatory registration, and the supervision is more stringent. If the majority of cosmetics manufacturers want to continue operating in the United States, they must strengthen their awareness of compliance and adapt to new regulatory requirements.