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Content Management

Navigating FDA Regulations for CPG: Ensuring Compliance with Esko

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Contributors

Gwenael Bultelle

Gwenael Bultelle

Category Specialist, CPG

Chris Janczar

Chris Janczar

Product Manager, WebCenter

Remaining compliant with the ever-changing landscape of FDA regulations impacting companies in the Consumer-Packaged Goods (CPG) industry is no easy feat.

However, understanding and implementing these changes into packaging, labeling, and artwork processes is non-negotiable.

And for good reason, the FDA has significantly increased its recall of foods, particularly when failure to disclose allergens is involved. For example, “FDA food recalls surged 27.6% from 105 in Q4 to 134 events in Q1” (Segwick).

Furthermore, recalls for undeclared allergens constituted 38.1% of the total figure in Q1 (Segwick).

In this article, we will explore the latest FDA regulatory updates, their impact on packaging requirements, best practices for maintaining compliance, and ensuring consumer safety.

Let’s dive into how automated tools can streamline the labeling content management process and reduce the risk of recalls.

New FDA Regulations: An Overview

The FDA has introduced several new regulations affecting the CPG industries. One major update relates to food labels specifying allergen information in general and, more specifically, for sesame products.

Sesame has been declared a major allergen, resulting in its inclusion in labeling, and triggering a series of changes to ensure consumer safety.

Additionally, new food additive bans are now being enforced in certain states, impacting approximately 38,000 product formulas according to Gwenael Bultelle, Esko CPG Category Specialist. Clearly, such a change has resulted in the need for significant modifications in product labeling and packaging.

For example, the California Food Safety Act seeks to ban the following additives: BVO, potassium bromate, propylparaben, and red dye 3. Introduced in 2023, the law won’t go into effect until 2027 (The National Agricultural Law Center).

The cosmetics industry also finds itself responding to an onslaught of regulatory changes implemented pursuant to the Modernization of Cosmetics Regulation Act (MoCRA), including mandatory allergen labeling, professional use indications, producer addresses, and national and international ingredient labeling standards.

MoCRA expands the FDA’s authority over cosmetics. Key aspects include:

  • Adverse Event Reporting: Mandatory reporting of serious adverse events.
  • Facility Registration: Cosmetic manufacturing facilities must register with the FDA.
  • Product Listing: Each marketed cosmetic product must be listed with the FDA.
  • Safety Substantiation: Manufacturers must ensure and document product safety.
  • Good Manufacturing Practices (GMP): FDA to establish GMP regulations.

With these changes, companies must adapt their packaging to include additional, producer, and professional use details. They highlight the need for a comprehensive labeling process.

For more details, visit the FDA’s MoCRA page.

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Ensuring Compliance: Where to Start

It goes without saying these changes have far-reaching implications for packaging and labeling. The changes necessitate a thorough review and update of all affected product labels.

This raises the question: what should companies do to implement regulatory changes in their labeling and packaging processes accurately and efficiently?

Here are several proposed steps to help you kick off the process:

  1. Know Your Product Portfolio: The first step is understanding your product portfolio, and all the packaging and labeling components impacted by regulatory changes.
  2. Define the Project Scope: Define all labeling change requirements, including whether they entail partial updates or complete redesigns of specified regulatory information.
  3. Leverage Technology: Using technology for collaboration and automation can significantly reduce the operational burden. Tools like Esko’s WebCenter provide a single platform for managing labeling changes, enhancing collaboration, and ensuring all regulatory requirements are met.
  4. Enhance Project Management: Effective project management and communication channels are vital to keep track of labeling projects, especially those involving multiple functions and tight deadlines.
  5. Provide Continuous Training: Train stakeholders regularly on processes, tools, and regulatory changes. This ensures everyone is up-to-date and capable of handling compliance requirements.

The Role of Digital Solutions in Compliance

Manual content management processes are often error-prone and inefficient. Digital solutions offer significant advantages in improving the speed, accuracy, and consistency of labeling content management.

WebCenter provides a comprehensive artwork management system that ensures all labeling content is managed and approved efficiently. The system facilitates automation, reducing the risk of errors associated with manual processes. It allows for the seamless approval of content and artwork, ensuring compliance with FDA regulations.

How WebCenter Supports Compliance

WebCenter is designed to help companies manage regulatory compliance effectively through several key features:

  • Content Management: WebCenter manages all labeling content, ensuring that each statement is approved and translated individually before being applied to the artwork. This reduces the risk of errors and ensures consistency.
  • Visual Approvals: The system provides multiple stages for visual approvals, allowing teams to review and approve content in context, further reducing the likelihood of mistakes and recalls.
  • Automation: By automating repetitive tasks, WebCenter minimizes human intervention and its associated risks, ensuring a more accurate and efficient labeling process.
  • Integration: WebCenter integrates with other systems, streamlining the labeling and packaging process. This integration ensures that all information is up-to-date and consistent across different platforms.
  • Centralized Document Management: Having all documents in one place enhances efficiency and compliance. Companies can quickly perform impact analyses and start projects to update affected labels, ensuring timely compliance with regulations.

Ready to Comply?

Adapting to new FDA regulations is critical for companies in the CPG industries.

Leveraging digital solutions like WebCenter can streamline the labeling content management process, ensuring compliance and reducing the risk of recalls.

By developing best practices and investing in technology, companies can stay ahead of regulatory changes and ensure consumer safety.

Additionally, staying ahead of regulatory changes helps reduce the risk of costly recalls that lead to brand damage, lost sales, and indirect costs such as continuing oversight and compliance, litigation, and temporary or permanent loss of customers (Food Safety Magazine).

To learn more about how Esko’s solutions can help your company navigate FDA regulations and enhance compliance, book a WebCenter discovery call.

Explore our comprehensive range of digital solutions designed to streamline your labeling and packaging processes.