FDA Issues New Resources Amid Traceability Rule Delay

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) issued new tools and Frequently Asked Questions (FAQs) to inform stakeholders about the Food Traceability Rule — which the agency recently delayed going into effect until July 2028  —  and help covered entities come into compliance.

Featured in this update are:

• New FAQs
• New examples of traceability plans for food processors, distribution centers and aquaculture farms and facilities
• New supply chain examples for eggs, produce, nut butter and dual jurisdiction facilities
• An At-A-Glance document on the rule
• Translations of the above documents into six additional languages (Spanish, French, Chinese, Thai, Vietnamese, Indonesian)

These tools are accessible from the FDA’s Food Traceability Rule webpage, along with:

• Supply chain examples for different commodities
• Fact sheets
• A webpage about traceability lot codes, including examples of how Key Data Elements (KDEs) could appear on invoices and bills of lading
• Translations of the codified portion of the rule, as well as supporting materials and tools
• An interactive tool that explains Critical Tracking Events and Key Data Elements
• An interactive tool that identifies partial and full exemptions to the rule
• Information on how to apply for a waiver or exemption, if eligible
• FAQs  

The Food Traceability Rule applies to domestic and foreign entities producing food for U.S. consumption and was issued in 2022 in accordance with the FDA Food Safety Modernization Act (FSMA).

What’s the Delay?

FDA proposed delaying the rule, initially set to go into effect Jan. 20, 2026, by 30 months in March. That moves the new compliance date to July 20, 2028.

The comment period for this proposed extension is open until Sept. 8.

The compliance date extension does not amend the requirements of the final rule, which will improve food safety and protect public health, said FDA. Instead, the extension affords covered entities the additional time necessary to ensure complete coordination across the supply chain in order to fully implement the final rule’s requirements — ultimately providing FDA and consumers with greater transparency and food safety, said the agency.

Even entities who were well positioned to meet the final rule’s requirements by January 2026 expressed concern about the timeline, said FDA, in part because of their reliance on receiving accurate data from their supply chain partners, who are not similarly situated. Therefore, FDA said it intends to allow industry additional time across all regulated sectors to fully implement the final rule’s requirements.

The FDA said it intends to use the extended time period to continue the agency’s work with stakeholders, including by participating in cross-sector dialogue to identify solutions to implementation challenges and by continuing to provide technical assistance, tools and other resources to assist industry with implementation. 

Industry Response Is Mixed.

Initial industry reactions to the agency’s decision to postpone the final rule were mixed, with some stakeholders questioning the public health impact of delaying the rule and others worried about the burden the rule would place on the supply chain.

FMI – The Food Industry Association welcomed the extension but encouraged FDA to adopt additional changes to the rule to ensure efficient implementation.

“FMI is grateful for FDA’s recognition of the need to extend the compliance date for the Food Traceability Rule, which is the most complex regulation the food industry has ever faced,” said FMI president and CEO Leslie G. Sarasin. “We also strongly believe that FDA should use this opportunity to make reasonable changes to the rule to reduce unnecessary complexity that would burden the supply chain and increase food costs to consumers.

“We fully support efforts to improve traceability throughout the supply chain and are working diligently to do so, but we must ensure that all stakeholders are engaged and that FDA can use the information required by the regulation to improve food safety without driving up costs throughout the supply chain. With a few key changes to the rule, FDA can meet the goal of reducing public health risk and facilitate more efficient and effective traceback investigations.”

Brian Ronholm, director of food policy at Consumer Reports, said the FDA's decision to extend the compliance date puts consumers’ health at risk.

“This decision is extremely disappointing and puts consumers at risk of getting sick from unsafe food because a small segment of the industry pushed for delay, despite having 15 years to prepare,” said Ronholm. “Many retailers have already said that they expect their suppliers to follow the rule’s requirements in advance of the compliance date, but today’s announcement may interfere with this progress. Delaying this critical food safety rule undermines the administration’s goal of making America healthy again.”

Blake Harris, technical director of the Institute of Food Technologists' Global Food Traceability Center, expressed disappointment in the extension but acknowledged the complexities of implementing the final rule.

"While we are disappointed by the 30-month delay in compliance with the FDA’s Food Traceability Rule, we acknowledge the complexities of implementing a regulation with global impact," he said. "However, public health must remain a top priority. The persistence of foodborne illness and recalls underscores the need for food industry stakeholders to invest in traceability and advance their efforts quickly, regardless of regulatory timelines. Moreover, as many global regulations and initiatives continue to prioritize traceability as a foundational element, it is critical for the food industry to stay aligned with these global efforts to meet both regulatory and consumer demands. We encourage food industry stakeholders to use this time to collaborate across the food system and adopt best practices that strengthen traceability. By working together and prioritizing interoperability, we can simplify traceability and better protect public health."

Angela Fernandez, senior vice president of market development, GS1 US, said the extension gives industry more time to work toward needed changes. 

"While the U.S. FDA has announced its intention to extend the Food Safety Modernization Act (FSMA) Rule 204 deadline into 2028, food safety remains paramount and continues to be a top priority for industry," she said. "GS1 US appreciates the acknowledgement from the FDA that more time is needed for many of those that manufacture, process, pack, or hold food products on the Food Traceability List to comply with the Final Rule. As a neutral, not-for-profit standards organization, GS1 US will continue our important work of collaborating with all of industry to achieve deeper levels of traceability and supply chain visibility with the goal of creating a safer food supply chain for consumers in advance of the Final Rule’s new deadline. This extension for industry compliance allows GS1 US and our members more time to work toward changes needed and working through pilot efforts to help them meet the requirements of the Rule by leveraging GS1 Standards for interoperability and efficient sharing of data up and down the supply chain."

Editor’s Note: Read more about the upcoming traceability rule in QA’s January/February feature, “Traceability Update: Collaborating Toward Compliance.”