Everything you need to know about adverse events under MoCRA

MoCRA has significantly changed the regulatory framework of cosmetic products in the United States. Among the novelties, there are new obligations related to adverse events that aim at increasing FDA powers.

According to MoCRA, an adverse event is defined as “any health-related event associated with the use of a cosmetic product that is adverse”. Whereas a serious adverse event occurs when an adverse event results in death, a life-threatening experience, inpatient hospitalization, a persistent or significant disability or incapacity, a congenital anomaly or birth defect, an infection, or a significant disfigurement and that requires, based on reasonable medical judgment, medical or surgical intervention to prevent an outcome described above.

As of December 29, 2023, Responsible Persons of cosmetics in the US market must have a system in place to ensure compliance with new reporting and record-keeping requirements. Moreover, as of December 29, 2024, labels must include contact details for consumers and authorities to report adverse events. Such information can be a domestic address, a domestic phone number, or electronic contact information, whether domestic or foreign.

Reporting and record-keeping

Let’s have a look at the new MoCRA requirements on adverse events. The US Responsible Person must receive the adverse events associated with the use of a cosmetic product in the United States. Consequently, it has to evaluate and report them to the FDA if they are serious within 15 days after the adverse event is received. In addition to this, the Responsible Person must keep the records of an adverse event for six years (three years for small businesses*). Furthermore, the Responsible Person must submit to the FDA any new medical information related to the initial report for one year after the submission.

MoCRA enlarged FDA competences linked to adverse events. Regarding this, the FDA can suspend facility registration if a cosmetic has a reasonable probability of causing serious adverse health consequences. Additionally, the FDA can request the Responsible Person to disclose the ingredients in fragrances or flavors if they have caused or contributed to a serious adverse event.

Latest updates from the FDA

The FDA informed the cosmetic industry to use the existing MedWatch form 3500A to report serious adverse events. The form should be sent via email or by mail together with supporting information, such as the labels. To this end, in December of last year, the FDA announced that they had updated the instructions document for mandatory reporting to include cosmetics. At the same time, the FDA confirmed they are working on an electronic system to submit the forms that will be launched in the following months.

*. Small businesses = companies whose average annual gross sales of cosmetic products in the United States for the previous 3-year period are less than $1,000,000, adjusted for inflation. The exemptions for small businesses do not apply to companies that manufacture, process, or sell the following products:

Cosmetic products that regularly come into contact with mucus membrane of the eye;
Injected cosmetic products;
Cosmetic products for internal use;
Cosmetic products intended to alter the appearance for more than 24 hours under customary or usual conditions of use and removal by the consumer is not part of such conditions.

Do you need help to comply with MoCRA? Obelis, with 35 years of international regulatory experience, is the ideal partner to support you in the compliance journey. Contact us today to discover our US services dedicated to manufacturers, brand owners, and producers of cosmetic products.

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Francesca Santacatterina

Regulatory Intelligence and Innovation Department

23.01.2024

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