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[FDA MoCRA Special Contribution #5] Prepare Now! Key Steps for Ensuring Regulatory Compliance

Date: 12/14/2023

mocra fda regulation

In the cosmetics industry, staying updated on regulations is crucial, especially with the recent historical changes due to MoCRA, compliance deadlines for facility registration and product listing are approaching, so cosmetic companies must take proactive steps. This article outlines key actions to ensure compliance and reduce regulatory risks.


Facility Registration and Product Listing

Early compliance requirements include registering facilities and listing products. Cosmetic companies must determine if facility registration with the FDA is necessary. It is important to evaluate which products require individual listings and which can be included in a single listing. Seek legal counsel for assistance.


Development of Reporting and Compliance Policies

Develop robust reporting and compliance policies. This includes updating the FDA annually on product listings and promptly notifying them within 60 days of any product changes or within 120 days of launching new products. These policies ensure regulatory compliance and transparency.


Adverse Event Reporting Procedures

Review adverse event reporting procedures. A well-defined and efficient system for reporting adverse events is crucial for consumer safety and regulatory compliance.


Current Good Manufacturing Practices (GMP)

Evaluate current GMP practices to align with FDA standards. Adhering to GMP guidelines is essential for maintaining product quality, safety, and regulatory compliance.


Recall Insurance Coverage

Review recall insurance coverage to ensure it adequately protects your business from unforeseen events. Comprehensive recall insurance mitigates financial risks associated with product recalls.


Safety Documentation and Toxicity Claims

Examine safety documentation to substantiate reasonable certainty of safety under typical product use conditions, including fragrances. Review safety and toxicity claims and ensure they are supported by scientific evidence.


In conclusion, addressing these regulatory considerations proactively is vital for the sustained success of your cosmetic company. Non-compliance can lead to severe consequences such as product recalls and damage to your brand's reputation. For more information on regulatory compliance obligations or guidance on navigating these challenges, reach out to our experienced team at Provision Consulting Group, Inc.


Navigating the regulatory landscape is complex, but with the right approach and professional guidance, your cosmetic company can thrive in an industry that prioritizes safety and compliance!


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