The FDA is finally banning the use of Red Dye No. 3, a petroleum-based synthetic dye that’s been raising eyebrows—and red flags—for decades. Widely used in candies, baked goods, frostings, and even some medications, Red No. 3 (also known as erythrosine) has long been linked to cancer in lab rats and potential behavioral issues in children. While it was banned from cosmetics in 1990, the dye remained in food and ingested drugs—until now.
Effective January 15, 2025, the FDA’s ban on Red No. 3 aligns the US more closely with global food safety standards. The European Union banned the additive back in 1994, citing health risks along with Australia, New Zealand, and other nations. US manufacturers, however, have until January 15, 2027, to remove the dye from food products, with drug producers granted an additional year.
Despite the ban, the dye will continue to appear on shelves during this grace period, with thousands of products currently containing Red No. 3, according to the Environmental Working Group (EWG). As brands now face the challenge of reformulating without this widely used colorant, the focus shifts to finding safe, effective alternatives and building supply chains that can handle the change.
Red flags for food makers: The growing trend of ingredient bans and restrictions
In 2023, California set a national precedent with its proactive stance on food additives. The California Food Safety Act, taking effect in 2027, bans Red 3 and other harmful chemicals from food products manufactured and sold in the state. The ban is part of a broader movement toward stricter regulation of food additives. Over the past decade, ingredients like trans fats and certain artificial sweeteners have faced similar scrutiny. This trend highlights significant progress at both federal and state levels in addressing potentially harmful substances in consumer products.
“Toxic chemical additives such as Red 3 are common in many foods, particularly candy and other sweets, putting millions of children at risk,” said Tasha Stoiber, EWG Senior Scientist, “This widespread exposure has raised concerns about lasting behavioral difficulties, including ADHD.” These concerns underscore the need for proactive measures to protect vulnerable populations and align the food industry with safer, more transparent practices.
Consumer demand for transparency and safety: Redefining the recipe for trust
Beyond regulatory pressure, consumer preferences are driving the shift toward cleaner labels and safer ingredients. Shoppers are no longer passive; they actively research ingredients and prioritize brands that reflect their values.
Kim Penberthy, a clinical psychologist and professor at the University of Virginia School of Medicine, has played a key role in raising awareness about the impact of food additives on health. In 2020, she co-authored research published in the Journal of Pediatric Neurology and Neuroscience, which linked food-color additives like Red 3 to increased hyperactive behavioral symptoms in children.
Penberthy applauds the FDA for taking steps to protect consumer safety, noting that “it’s a good reminder to be intentional about what we put in our bodies,” and for consumers to “demand accountability and transparency in food and product safety.” By eliminating Red Dye No. 3 and embracing safer alternatives, manufacturers can tap into this growing demand and reinforce trust with their audiences.
Identifying suitable alternatives: The technicolor challenge
Replacing Red 3 is no simple task. Its vibrant hue and stability have made it a favorite in candies, baked goods, and other products. However, finding a suitable substitute requires careful consideration of factors like pH levels, heat resistance, and cost.
Natural alternatives such as beet juice, paprika extract, and carmine offer promising options but come with their own challenges. Some lack pH or heat stability, while others face supply chain constraints. Synthetic alternatives may provide more stability but risk future regulatory scrutiny. The road ahead demands a more nuanced approach to sourcing and formulation.
As brands navigate these complexities, building diverse supply chains becomes critical. “There isn’t a one-size-fits-all chemical that will replace Red 3 in every application. Brands have a lot of work to do to not only reformulate products but also build more diverse supply chains that may need to provide different color alternatives,” said Kari Barnes, Regulatory Standards Manager at TraceGains. This level of adaptability will be key to maintaining product quality and consumer satisfaction.
The role of AI technology in rapid reformulation: Speeding up the spectrum shift
In the race to reformulate, technology plays a pivotal role. Digital platforms like TraceGains enable manufacturers to adapt quickly and efficiently by offering access to a vast network of pre-vetted suppliers and real-time regulatory updates.
TraceGains’ intelligent sourcing, powered by thoughtfully applied artificial intelligence (AI), redefines how F&B companies innovate. By connecting brands with suppliers and ingredients they may have never discovered otherwise, AI transforms the sourcing and product development process into a cross-functional, mission-driven discipline.
AI doesn’t just streamline workflows—it unlocks opportunities that even seasoned procurement officers might miss. It identifies trends across the broader industry, maps connections between product concepts, and surfaces viable solutions. TraceGains’ industry-specific AI data, built on a vetted global network of suppliers, brands, and manufacturers, goes beyond consumer-fed data to deliver actionable insights. The result? Smarter, faster, and more sustainable product innovation.
Like what you see? Continue watching this on-demand demonstration of Formula Management here.
3 strategies to successfully reformulate after the Red Dye No. 3 ban
1. Leverage collaborative technology
TraceGains provides centralized solutions for ingredient sourcing, regulatory compliance, and formulation management. By bringing together R&D, procurement, and quality teams, TraceGains helps eliminate silos, accelerates decision-making, and reduces errors. AI enhances this collaboration by spotting risks and potential issues early, ensuring reformulated products meet quality standards without unnecessary delays. The technology even enables R&D teams to model product variations, simulating development outcomes before production begins, saving valuable time and resources.
2. Diversify supply chains
Reformulation success hinges on building a resilient and flexible supply chain. TraceGains’ AI integration enables brands to source from a global network of vetted suppliers, identifying options tailored to specific applications. Beyond ensuring ingredient availability, AI adds sustainability insights to the equation, helping brands align sourcing decisions with their environmental and social responsibility goals. This level of intelligence ensures that businesses remain agile, adapting quickly to shifts in consumer demand, marketplace changes, or sourcing challenges.
3. Prioritize consumer preferences
Consumers increasingly demand clean, natural, and sustainable products. Reformulation is an opportunity to strengthen trust and loyalty by meeting these expectations head-on. TraceGains’ intelligent sourcing tools make it easier to find natural replacements while maintaining transparency about product changes. AI also brings critical information together in new ways, uncovering innovative ingredient solutions and helping teams quickly qualify and move them into production. This agility not only meets consumer demands but elevates a brand’s reputation for quality and responsibility.
A colorful future without Red Dye No. 3
The FDA’s ban on Red Dye No. 3 is more than a regulatory milestone—it’s a wake-up call for the F&B industry. By embracing agility, leveraging technology like AI, and prioritizing transparency, brands can turn this challenge into an opportunity for innovation and growth. As the industry moves toward cleaner and safer products, those who adapt quickly and effectively will lead the way, proving that vibrant results don’t have to come at a cost to consumer health.
Learn how TraceGains’ NPD Suite and Formula Management solutions can help your brand navigate reformulation challenges and stay ahead in the evolving regulatory landscape.