Registrar Corp sees software helping cosmetics industry “not prepared” for new FDA adverse event reporting requirements

24 Jul 2024 --- US-based Registrar Corp introduces a “first-of-its-kind” Adverse Event Management (AEM) software to help cosmetics companies comply with the FDA Modernization of Cosmetics Regulation Act (MoCRA).

The company says it is the world’s largest FDA compliance company, with 32,000 clients in 190 countries, and claims industry players are not prepared for the FDA’s new adverse events requirements, which were previously voluntary.

An adverse event is “any health-related event associated with the use of a cosmetic product that is adverse,” according to the Federal Food, Drug, and Cosmetic Act. Jaclyn Bellomo, Registrar’s senior director of Cosmetic Science and Regulatory Affairs, says it can include death or life-threatening experience, hospitalization, infection, disability, birth defect and also disfigurement.

Registrar Corp warns MoCRA enforces “stringent” requirements for such reporting, which was previously limited to drug products and medical devices. They include:

• Displaying contact information on primary and secondary packaging.
• Collecting personal and medical information from the consumer.
• Investigating to judge if the adverse event is a serious event.
• Reporting such serious adverse events to the FDA within 15 business days.
• Recording all health-related adverse events and maintaining for up to six years.

The new regulations will impact compliance, regulatory departments and require tight coordination with marketing (product labeling), quality and manufacturing (investigation), legal (consumer liability) and R&D (formulation safety).  

“MoCRA’s adverse reporting requirements are incredibly complex and the existing consumer complaints process simply will not work,” states Bellomo. 

“The consumer’s medical data needs to be securely collected, processed in real-time and investigated quickly to meet the 15-day serious adverse reporting requirement.”

Adverse events reporting was previously limited to drug products and medical devices.Streamlining adverse event reporting
Registrar Corp positions AEM software for cosmetic company use as it was built to securely intake sensitive consumer medical data, track all adverse events for each product globally, transmit information to internal stakeholders and format serious adverse events into the FDA MedWatch format for submission to the agency.

AEM is touted for its consumer-friendly intake, real-time monitoring, protection of personal and medical data and ability to enable reports to be FDA MedWatch-ready.

The business describes how customers can swiftly scan a QR code on the label to input the necessary information, images and paperwork for a prompt investigation. Additionally, AEM monitors adverse events for every SKU in real time to get early notification of quality issues. 

AEM’s ISO27001-certified storage security also offers serious adverse event reports pre-formatted to the FDA requirements for fast upload and submission.

“In the past six months, we have helped over a thousand cosmetics companies get MoCRA ready with product listings, registrations and label reviews,” says Raj Shah, CEO of Registrar Corp. “As FDA enforcement now ramps up and retailers press on brands to get fully MoCRA compliant, we recognized the urgent need to solve their Adverse Events need with our AEM software.”

MoCRA transformations
We spoke to the FDA about the changes under MoCRA while the it imparted guidance to businesses.Earlier this month, Personal Care Insights spoke to the FDA amid the registration deadline. We also learned about the changes under MoCRA while the agency imparted guidance to businesses: 

The agency said, prior to MoCRA:

• Manufacturers were not required to register their cosmetic establishments or file product formulations with the FDA.
• FDA did not have mandatory recall authority for cosmetics.
• FDA published recommendations in a draft guidance for cosmetic Good Manufacturing Practices (GMPs). Under MoCRA, the FDA will establish by regulation Good Manufacturing Practice (GMP) requirements for facilities that manufacture cosmetic products. A final rule for GMPs will specify the date upon which the industry must comply with the rule.
• Adverse event reporting (including serious adverse events) was voluntary.

The spokesperson added: “For safety substantiation, under US law, cosmetic products and ingredients do not need FDA approval before they go on the market. The one exception is certain color additives, which must be approved for their intended use. Companies and individuals who market cosmetics are responsible for ensuring their products’ safety.”

“MoCRA does not change this requirement, however, under MoCRA, a responsible person is now required to ensure and maintain records supporting adequate safety substantiation of their cosmetic products. Manufacturers can use relevant safety data already available to support the safety of their products. Animal testing is not a requirement for marketing a cosmetic product. It’s important, however, that all the data used to support safety is derived from scientifically robust methods.”

By Venya Patel