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[FDA MoCRA Special Contribution #3] FDA is now enforcing! FDA's Authority

After 84 years, the FDA Modernization of Cosmetics Regulation Act (MoCRA) is being revised and is set to take effect on December 29, 2023.

Starting this October (less than two months away!!!), the FDA will be accepting

all relevant submission forms.

In light of this, Provision Consulting Group is publishing related content to raise awareness among cosmetics manufacturers, processing companies, brand companies, distributors, and related facilities about the importance of MoCRA and to help them prepare.

(1) Under MoCRA, what authority does the FDA have, and what role does it play?

The newly revised MoCRA grants the FDA expanded authority to ensure the safety of cosmetic products and consumers.

  1. Authority to Access Records

The FDA now has the authority to access, review, and copy all records and information related to products, including data regarding the safety of cosmetic products.

In particular, when there is a suspicion that a cosmetic product or its ingredients have been manufactured unlawfully or inappropriately and pose a significant risk of serious side effects, the FDA will exercise its right to access and investigate all records related to that cosmetic product.

2. Authority for Mandatory Recall

Under MoCRA, the FDA has been granted the authority to mandate product recalls when cosmetics are determined to have been manufactured unlawfully or inappropriately, when labeling is incorrect, or when they fail to provide adequate information. This authority is exercised when there is a possibility that the use or exposure to such cosmetics may result in serious adverse effects or even death.

3. Authority to Suspend Facility Registration

The FDA has the authority to suspend the registration of manufacturing facilities if it is determined that cosmetics produced or processed by the registered facility have the potential to cause serious adverse effects or even death within the United States. This authority can be exercised when it is believed that other products from the facility are not adequately isolated from the affected product and may impact other products as well.

As the FDA's authority has become significantly more enforceable and expanded than before, it has become an essential matter for related facilities to properly understand MoCRA, adhere to regulations, and comply with the law in order to sell cosmetics in the U.S. market. <Related Link>

Provision work professionally while meeting clients' needs.

We will streamline the regulatory processes

so that our clients can utilize their time

and money most efficiently.

Experience the best FDA approval directions and solutions!

If you have questions about FDA regulation of Medical Devicese,

OTC Drugs, Cosmetic or importing of medical devices to the United States,


Office 1-909-493-3276


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