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Why FDA Food Traceability Regulations Are a Business Opportunity

It’s going to be a busy couple of years for the food industry as the Food and Drug Administration (FDA) formalizes key parts of its plan to modernize and further secure the U.S. food supply chain. The next milestone for FDA food traceability regulations is just four months away, so let’s take a look at the requirements — and why food companies should embrace them as an opportunity to improve their businesses.

But first, if you’re intrigued by the idea that opportunities are “hiding” in the FDA food traceability regulations, join us for our “Safety, Regulatory Compliance & Beyond: Leveraging Traceability to Optimize the Food & Beverage Supply Chain” webinar on Wednesday, August 10, at 1 p.m. EST. Our experts will break down the “whys” and “hows” of traceability, discuss the real-world applications and value-adds, and take your questions.

Recap of FDA food traceability regulations & upcoming deadlines

Here’s a quick rundown of what’s on the table and upcoming deadlines.

Food Safety Modernization Act (FSMA)

      • Signed into law on Jan. 4, 2011
      • Aims to ensure the food supply is safe by shifting the focus to preventing contamination rather than responding to it
      • Applies to human food as well as to food for animals, including pets

Proposed Rule (FSMA 204)

      • Establishes additional traceability recordkeeping requirements for people who manufacture, process, pack, or hold foods on the Food Traceability List
      • Food Traceability List contains foods with additional traceability recordkeeping requirements (see table below)
      • Stakeholders to establish and maintain records with key data elements (KDEs) associated with different critical tracking events (CTEs)

Key dates

      • Nov. 7, 2022: FDA to finalize and submit the Food Safety Modernization Act (FSMA) Proposed Rule to the Federal Register
      • January 2023: Proposed Rule goes into effect
      • Jan. 6, 2025: Deadline for full compliance

The FDA has also launched the New Era of Smarter Food Safety and an accompanying New Era of Smarter Food Safety Blueprint, which envision a modern approach to ensuring food safety through digital, tech-enabled traceability. Get more details in our blog here.

FDA food traceability regulations: What to know now and how to seize opportunities

This is really just a preview of our August 10 webinar about leveraging traceability. We’ll touch on a few key points below; sign up for the webinar to take a deep dive.

Just the facts

The FSMA 204 deadlines are set. You’ll have to be fully compliant in about two years, so the time to prepare is now.

The Food Traceability List is a living document. More and more food items are sure to be added over time.

The FDA is committed to modernizing and securing the U.S. food supply chain. Expect the Agency to continue promoting (and regulating) traceability in a digital supply chain. This includes improving recall management.

Where’s the opportunity?

End-to-end traceability makes everything better. With the right solution, you’ll not only be compliant — you’ll make your supply chain faster, leaner, and more cost-effective.

“1-up, 1-down” is useful, but antiquated. Today, 1-up, 1-down traceability is merely a facet of end-to-end traceability (and visibility and transparency) in a digital supply chain. The right solutions transform your supply chain into an ecosystem that optimizes operations and creates opportunity and value beyond the point of sale.

Serialization is the building block of compliance — and added value. Serialization turns every product into a “digital asset” that can be traced in real time from virtually any location, yielding practical benefits to your operations. But these digital assets can accomplish much, much more, including brand protection and consumer engagement.

Traceability enables precise, targeted recall management — which means better outcomes for your brand. We’ve all heard the statistic that the average food recall costs $10 million. With traceability, you can locate specific items quickly, identify where they came from (e.g., grower, warehouse), take clear, decisive action to remove only those items from circulation, and protect consumers and your reputation.

Traceability in a digital supply chain means less clutter — literally. Do you have nightmares about back rooms full of boxes stuffed with paperwork? Traceability turns your nightmare into an operational dream. Get rid of all the paper and gain the power to quickly dial up any document, any time, from any location, including from mobile devices.

Traceability and added value

Traceability is the key to keeping consumers happy and inspired. Consumers are thinking deeply about the things they buy — where they come from and what goes into making them. They also expect to interact with the brands they trust. We wrote way back in October 2020 that supply chain traceability was building a new kind of consumer kingdom; it was true then, it’s true today, and it will be true tomorrow.

The era of digital assets and smart products is here. Products are no longer just products. With serialization and traceability, products are gateways to experiences. They’re beacons to broadcast information. They are conduits for hyper-targeted and hyper-personalized consumer engagement.

Final thoughts

FDA food traceability regulations are center stage in FSMA, the Food Traceability Proposed Rule (FSMA 204), the Food Traceability List, and the New Era of Smarter Food Safety. The deadlines are coming and you should be preparing.

But now you know that savvy companies will see traceability as more than a compliance mandate from the government — they’ll see it as a technology that creates a universe of opportunities for their businesses and brands.

Companies that are thinking only about the mechanics of complying with FDA food traceability regulations will miss these opportunities to be proactive about ensuring food safety and quality, reducing  risks, protecting and building their brands, and leveraging every single product to connect with individual consumers in exciting, meaningful ways.

We don’t want you to miss these opportunities. To get started, sign up for our food traceability webinar to see how traceability works and how it delivers value.

Next, contact us to schedule a short demo of our food and beverage solutions, including our award-winning Traceability System and Mobile Traceability App. In about 15 minutes, our supply chain experts will show you how we create end-to-end traceability in a fully interoperable digital supply chain that’s visible anytime, anywhere.

Last, take a look at our other food traceability materials, some FDA links, and our shortened version of the Food Traceability List.

Our FSMA & Food Traceability Resources

Other FDA Resources

Food Traceability List (see full FDA document here)

FDA Food Traceability List

Food Traceability Data: Not Just for Compliance Anymore

As the Food and Drug Administration (FDA) continues to evolve its traceability and modernization initiatives across the U.S. food supply chain, the need for more accurate food traceability data is more important than ever.

Foundationally, the FDA’s initiatives require companies to have digital traceability systems in place that facilitate greater food safety. But food traceability data means more than ensuring you’re complying with regulations: It offers significant business value. Let’s take a look.

FDA’s food traceability initiatives: a refresher

In 2011, Congress enacted the Food Safety Modernization Act (FSMA) to regulate the way foods are grown, harvested, and processed in the United States. The law transforms the nation’s food safety system from an after-the-fact response to foodborne illness to a proactive posture aimed at prevention.

To address the rapid and effective tracking and tracing outlined in FSMA, the FDA in April 2019 launched the New Era of Smarter Food Safety, a tech-enabled approach to food traceability to ensure food safety, and the New Era of Smarter Safety Blueprint (July 2020), which outlined the Agency’s vision for how to get there and included the Food Traceability Proposed Rule, which defines specific traceability recordkeeping requirements for foods on its Food Traceability List.

Food traceability data delivers benefits beyond mere compliance

Although food traceability data serves as the cornerstone of effective recall management and outbreak prevention as required by the FDA, it means much more than compliance. Here are three ways food traceability data can drive business value to support sustainable growth.

Create operational efficiencies

Food traceability data yields complete, real-time visibility into operations across every node in the supply chain. This empowers food companies to take immediate action, solve problems, coordinate with partners and regulators, and keep things moving.

For example, by tracking a product’s ingredients from harvest through production through the last mile to delivery, you can quickly trace raw materials backward and forward, pinpoint supply chain weaknesses or trouble spots, and strengthen your recall program and minimize the impact of recalls. And with a traceability system that allows you to monitor products anywhere in transit, you can collect data on environmental conditions, track the location of all your deliveries, and set precise parameters for alerts.

This food traceability data allows you to proactively protect your shipments, safeguard their environmental integrity, track their position on land, sea, and air, and intervene immediately should something seem awry, such as a spike in temperature or a route diversion. Add critical tracking events (CTEs) and other information (e.g., quality inspections) to the process and you’ve got an indelible product provenance from farm to table.

Build consumer engagement and trust

These days, consumers are more attuned than ever to family health and finances. They want to know more about what they’re eating, such as ingredients, how food is raised or grown, and the safety and environmental practices used to produce it. They want to feel good about what they eat and where they are spending their money. By supplying information that meets this demand, you build trust and loyalty and build a community of customers who will advocate for your products.

The simple truth is that food traceability data creates tremendous opportunities to communicate with consumers and nurture more committed relationships. You can back your claims and prove your product is what you say it is.

Protect your brand

This dovetails with consumer engagement and trust. With modernized, secure, and compliant food traceability protocols, you can better collaborate with partners and authorities if there’s a recall. In this scenario, you’re not only protecting consumers from a health hazard — you’re safeguarding your brand from bad publicity. And with a transparent approach to engaging with customers about the foods they consume, you create a strong brand image that conveys trust, credibility, and reliability. You can even use your food traceability data as a core differentiator in your value proposition messaging.

Final thoughts

Food traceability data has always been important, but the FDA has clearly put it center stage with FSMA, the New Era of Smarter Food Safety, the Food Traceability Proposed Rule, and the Food Traceability List.

Do not expect this to change.

rfxcel believes industry leaders will see traceability as an investment in their businesses and brands, not a compliance mandate from the government. If fact, savvy companies will know the FDA’s initiatives are an opportunity to be involved in shaping the future of the U.S. food supply chain. Keep an eye out this summer for more from rfxcel about how you can tap into the FDA’s initiatives to help lead the transformation of the U.S. food supply chain. As we said above, this is a moment of opportunity for the food industry. Don’t miss the boat.

In the meantime, take a look at our solutions for food and beverage:

Contact us today for more information and to schedule a short demo of our food traceability solutions. Get started now and take advantage of all the opportunities food traceability data can create for you.