Why Are FDA Food Contact Notifications No Longer Effective?
Have you heard about the recent updates to FDA Food Contact Notifications (FCN)? The FDA has determined that several FCN are no longer effective due to changes in manufacturing and regulatory standards. These updates directly affect businesses that rely on food contact substances (FCS). Furthermore, they include strict compliance deadlines that organizations must meet.
Understanding these changes is essential to stay ahead of compliance requirements and avoid disruptions. In this article, we will explore what these updates mean, highlight the FCN that are affected, and explain how your business can adapt effectively.
What Are Food Contact Notifications (FCN)?
Food Contact Notifications (FCN) are approvals issued by the FDA for specific substances used in food contact materials. These substances are assessed for safety and compliance with regulations under the Federal Food, Drug, and Cosmetic Act (FD&C Act). Each FCN has the following characteristics:
- Manufacturer-specific: Valid only for the listed manufacturer or supplier.
- Purpose-specific: Tied to a particular use case or food contact material.
- Safety-driven: Assessed for human and environmental safety.
When the FDA declares an FCN ineffective, businesses must stop using the associated substance unless it receives re-approval.
Why Are Some FCN No Longer Effective?
The FDA declared specific FCN ineffective for two main reasons:
- Abandonment by Manufacturers: Manufacturers voluntarily informed the FDA that they have ceased producing, supplying, or using specific substances. Commitment letters submitted by these manufacturers confirmed that these substances would no longer be used in food contact applications.
- Regulatory Updates: Recent changes to FDA regulations now allow the agency to declare an FCN ineffective for reasons beyond safety, such as the cessation of production. This aligns with updates to Section 170.105, enabling the FDA to streamline approvals and ensure public safety.
Highlighted Affected Substances
Some of the affected food contact substances include:
- Glycine, N,N-bis[2-hydroxy-3-(2-propenyloxy)propyl]-, monosodium salt: Used in coatings for food packaging (FCN No. 59).
- Fluorinated polyurethane anionic resin: Commonly applied in grease-proofing food paper products (FCN No. 187).
- Diphosphoric acid polymers with ethoxylated perfluoroether: Found in grease-proof paper coatings (FCN No. 195).
These are just a few examples. The FDA has provided a compliance deadline of June 30, 2025, for certain FCN to give businesses time to transition. For the complete list of affected substances, visit the FDA’s No Longer Effective FCN Inventory.
What Does This Mean for Your Business?
If your company uses any of the affected FCS, you must act swiftly to remain compliant:
- Audit your inventory: Identify materials containing ineffective FCS.
- Transition to alternatives: Replace discontinued substances with FDA-approved options.
- Monitor deadlines: Ensure that products under the compliance deadline are phased out before June 30, 2025.
Failing to meet compliance requirements could result in operational disruptions and legal consequences. The FDA’s updates to Food Contact Notifications reflect the evolving nature of food safety regulations.
By understanding these changes and adapting your processes, you can ensure compliance and maintain operational continuity. For expert guidance on navigating FDA regulations, contact Quality Smart Solutions today!
