US FDA cosmetics regulatory laws have been transformed and modernized to ensure consumer safety. The Modernization of Cosmetics Regulation Act (MoCRA) implementation ushers in the new era of cosmetics regulation. The act introduces an array of new requirements for the cosmetics industry. Cosmetics product listing, safety substantiation, facility registration, GMP compliance, labelling requirements are some of the pillars of MoCRA. Notably, cosmetics adverse event reporting is one of the most important critical regulatory requirements under the newly formulated MoCRA. Navigating the MoCRA adverse event reporting guidelines can be a tricky task. Hence, we have prepared this guide for cosmetics product companies. Additionally, we have provided some tips for cosmetics adverse event reporting to help you comply with the MoCRA guidelines.

Adverse event reporting is one of the key focuses of MoCRA. Hence, cosmetics companies should aim to accurately submit reports in a timely manner. Moreover, they should establish comprehensive systems for collecting and evaluating cosmetics adverse event reports. Additionally, they should train their workforce on reporting protocols, maintaining thorough records, and actively monitoring adverse events. Furthermore, cosmetics companies should proactively detect and address safety concerns.

What is an adverse event in cosmetics industry?

An adverse event is any untoward medical occurrence that is reasonably attributable to the use of cosmetics products. Basically, it is a reaction, such as a rash, redness, burn, hair loss, headache, infection, etc., caused by using a cosmetics product.

What is a serious adverse event?

A serious adverse event is any undesirable experience associated with the use of a cosmetics product that can lead to:

• Infection
• Inpatient hospitalization
• A persistent or significant disability or incapacity 
• A congenital anomaly or birth defect 
• Significant disfigurement
• A life-threatening experience 
• Death

MoCRA adverse event reporting requirements

MoCRA adverse event reporting requirement is a key obligation placed on cosmetics manufacturers. As per MoCRA guidelines, cosmetics serious adverse event reporting is one of the duties of the designated “responsible person.” The responsible person is the distributor, packer, or manufacturer of a cosmetic product whose name appears on the product’s label in accordance with section 609(a) of the FD&C Act or section 4(a) of the Fair Packaging and Labeling Act.

The MoCRA guidelines mandate the responsible person to promptly report any serious adverse event that may have occurred upon the use of the cosmetics product in the U.S. This should be reported to the FDA within 15 business days. Notably, the adverse event reports must include a copy of the cosmetics product label. Furthermore, for 1 year after the initial submission, new medical information related to the initial report has to be submitted. Additionally, U.S. companies are required to retain adverse event records associated with the cosmetics product usage for 6 years.

Therefore, cosmetics manufacturers are required to mandatorily comply with the MoCRA adverse event reporting guidelines. These guidelines are in place to protect the consumer health.

MoCRA adverse event reporting guidelines for responsible person 

MoCRA adverse event reporting requirement is one of the major duties of the designated “responsible person.” The cosmetics adverse event report should include the following information: 

1. Patient information 
2. Details of the serious adverse event and its outcome 
3. Suspect product(s) information 
4. Copy of the cosmetics product label found on or within the retail packaging 

How to submit cosmetics product serious adverse event reports to the FDA? 

The responsible person has to report the serious adverse event associated with the usage of the cosmetics product. The person will be required to collate supporting evidence and prepare the report. We have provided a brief overview of the process:

1. FDA recommends that the designated responsible person uses the current downloadable and fillable MedWatch Form 3500A to report cosmetics product serious adverse events.
2. This 7-page MoCRA adverse event reporting form requires detailed information about the patient, adverse event, and suspected product.
3. The form has to be completed and submitted with additional supporting information, such as cosmetic product label copies.
4. Additionally, images evidencing the serious adverse event have to be submitted.
5. On the other hand, adverse event report can be submitted via email or mail to the FDA’s Center for Drug Evaluation and Research.

Currently, the FDA’s Cosmetics Direct portal for cosmetics facility registration and product listing does not allow adverse event reporting. However, the FDA is trying to develop a system for mandatory electronic report submission. 

Notably, you will have 15 business days to collect, organize, fill, and submit the report from the day the serious adverse event has been notified. Hence, it can be challenging for cosmetics companies to accurately report serious adverse events in a timely manner.

MoCRA adverse event reporting guidelines for other adverse events

MoCRA adverse event reporting guidelines are in place for reporting adverse events other than serious adverse events. The responsible person has to receive adverse event reports and maintain proper records of the incidence.

As per MoCRA guidelines, the cosmetics product label must mention the responsible person’s contact information. This information can include domestic address, phone number, or electronic contact information. The contact information has to be provided on the product label so that consumers can report the occurrence of adverse events.

Furthermore, the MoCRA adverse event reporting guidelines requires the responsible person to maintain records of the adverse and serious adverse events for a period of 6 years. During inspections, FDA authorities can request records of adverse events.

5 Tips for cosmetics adverse event reporting

Compliance with MoCRA adverse event reporting guidelines is a mandatory requirement for companies in the cosmetics industry. We have provided some tips to help you comply with the cosmetics adverse event reporting guidelines.

• Employee Training: Provide comprehensive training to employees on the nuances of adverse event reporting. Guide them on how to identify and evaluate adverse events. Additionally, train them on preparing the necessary reports. Furthermore, make them aware of the importance of proper record keeping.
• Robust Reporting System: Establish a comprehensive system for collecting and evaluating cosmetics adverse event reports. This system should cover protocols for identifying and thoroughly evaluating adverse events. Additionally, the system should be able to determine whether the event falls under the category of “serious”.
• Reporting within the deadline: Ensure that the entire adverse event report is submitted to the US FDA within the 15-business day deadline. Additionally, ensure a copy of the cosmetic product’s label is included as part of the report. Thus, accurately submitting the report in a timely manner is crucial.
• Meticulous Record Keeping: Meticulously maintain complete records pertaining to each adverse event. These records linked to events associated with the use of cosmetic products must be preserved for a minimum of 6 years.
• Continuous Monitoring: Constantly monitor adverse event reports to detect any emerging trends. This data can be used to identify safety issues associated with a cosmetic product. After identifying safety issues detected with the help of these findings, the product can be modified to prevent further adverse events.

Pharmadocx Consultants: Your US FDA cosmetics regulatory support

MoCRA implementation is a pivotal moment in the US FDA cosmetics regulation. MoCRA guideline compliance is not only a regulatory requirement but also it improves brand reputation. In this blog, we have discussed MoCRA adverse event reporting requirements. Additionally, we have provided some tips to help companies in the cosmetics industry to easily comply with these requirements. However, navigating the MoCRA guidelines is arduous. The Pharmadocx Consultants team will help you comply with MoCRA guidelines in a seamless manner. To avail our comprehensive US FDA cosmetics regulatory service, simply drop an email at [email protected] or call/Whatsapp on 9996859227.