NEWS & BLOGS

Beyond MoCRA: Using the FDA's New Dashboard to Build Trust and Brand Value.

Provision Consulting Group
Sep 15
3 min read

Updated: Sep 24

The U.S. FDA recently launched a new online dashboard for tracking cosmetic product adverse events in real time. This is a significant change brought on by the implementation of the Modernization of Cosmetics Regulation Act (MoCRA), demonstrating that the FDA's surveillance for consumer safety has become more transparent and rigorous.

What Has Changed to MoCRA Dashboard?

Previously, adverse event data for cosmetics was managed through annual reports submitted by companies to the FDA, making it difficult for the industry and consumers to access. The newly introduced 'FDA Adverse Event Reporting System' dashboard is a tool that visualizes adverse event reports submitted directly by consumers, making the data easily accessible to everyone. The dashboard provides the following information:

Real-time data access: Adverse event data, which was previously only available in report form, can now be viewed in real time.
Increased transparency: It provides various analytical data, such as the type of side effects consumers experienced and which ingredients were flagged as potential issues.
Early warning signal: A sudden surge in adverse event reports for a specific product on the dashboard can serve as a potential safety warning signal.

The Impact of the Real-Time Adverse Event Dashboard on Businesses

The launch of this dashboard is more than just an improvement in data access; it presents new challenges for cosmetic companies in this new regulatory environment.

Increased Responsibility: Under MoCRA, the 'Responsible Person' must report a serious adverse event within 15 days. The real-time dashboard makes a company's response status more transparent.
Visible Regulatory Risk: Consumers, competitors, and even the media can now view adverse event data in real time. This means that labeling errors, ingredient issues, or exaggerated claims can be exposed immediately.
Importance of Proactive Response: The dashboard data shows consumer reactions instantly, which means companies must establish a system to proactively identify and respond to potential safety issues.
Test of Brand Trust: An inadequate response to adverse events can be easily exposed through the dashboard data, which can lead to a direct loss of brand trust. Conversely, brands with a strong safety management system can gain higher credibility. In this 'transparent data environment,' safety management capability becomes the brand's competitive advantage.

Ensuring Regulatory Stability Is the Top Priority

The public launch of the FDA's real-time adverse event dashboard shows that the regulatory environment under MoCRA has evolved. Complying with regulations is no longer a passive duty; it has become a proactive business activity that demonstrates a brand's transparency and trustworthiness. In this new era, simply completing FDA registration is not enough; a company's ability to manage safety and respond to risks is what defines its global market competitiveness.

Going forward, cosmetics companies must consider the following strategies:

Strengthen internal AE (Adverse Event) management systems: A process is needed to immediately record and report consumer complaints or skin reactions as they are received.
Re-examine labeling and ingredients: Proactively eliminate risk factors for adverse events, such as allergens, inappropriate marketing claims, and exaggerated phrases.
Prepare a crisis communication plan: With data being made public, companies need to prepare a scenario for how to respond to consumers and the market when an adverse event occurs.