Modernization of Cosmetics Regulation Act of 2022

by | Nov 13, 2024 | Compliance, Cosmetics, FDA, QMS, Quality, Quality Systems, Requirements

Did you know that on average people use 6 to 12 cosmetics products daily? [1] There are many different types of cosmetics products. Makeup, shaving cream, perfumes, body cleansers, and moisturizers are all different types of cosmetic products. In 2022, the Modernization of Cosmetics Regulation Act of 2022 was released to cover all cosmetic products. This is the most significant expansion of FDA’s authority to regulate cosmetics since the (FD&C) act was passed in 1938. [1]

The Modernization of Cosmetics Regulations Act of 2022 has changed the standards for cosmetic products distributed in the United States. These regulations have given the FDA the authority to have access to all records related to cosmetic products. [1] They also have the authority to order a mandatory recall of cosmetic products that are adulterated, misbranded or can cause serious injury or death. [1]

There are also several new requirements for the cosmetic industry. All serious adverse events must be reported to the FDA within 15 days of the event. [1] Serious adverse events include death, inpatient hospitalization, infection, significant disfigurement, and many more. [1] All Manufacturers and processors must register their facilities with the FDA, this also needs to be renewed every 2 years. [1] The FDA requires a list that includes all products, their ingredients, and all updates of these products. Another major requirement is that all organizations are responsible for the safety of their products.

The Modernization of Cosmetics Regulation Act of 2022 is a major change to the cometic field. At EMMA international our team of experts can help ensure that your organization is compliant   with these new regulations. Give us a call at 248-987-4497 or email us at info@emmainternational.com to get in touch with our team of experts today.

[1] Act of 2022 (MoCRA)https://www.fda.gov/cosmetics/cosmetics-laws-regulations/modernization-cosmetics-regulation-act-2022-mocra

EMMA International

EMMA International

EMMA International Consulting Group, Inc. is a global leader in FDA compliance consulting. We focus on quality, regulatory, and compliance services for the Medical Device, Combination Products, and Diagnostics industries.

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