Food colorings have become one of the most fiercely debated issues in food policy today. But how much of the outrage is grounded in science, and how much is driven by headlines and regulatory theater?
In the second episode of Smarter Food Safety, host Frank Yiannas sits down with Dave Schoneker, a chemist and regulatory expert with nearly five decades of experience in food additives. As the President of Black Diamond Regulatory Consulting and former President of the International Association of Color Manufacturers, Dave brings deep technical insight to a highly charged topic. Together, they dismantle the most pervasive myths about synthetic dyes and explain the unintended consequences of rapid reformulation.
Ecolab is proud to sponsor the podcast and help bring these critical conversations to the professionals navigating this complex landscape.
The persistent myth of synthetic food dyes "banned in Europe"
One of the most common claims driving consumer panic in the U.S. is that synthetic food dyes are banned in Europe. It simply isn't true.
Red 40, Yellow 5, Yellow 6, Blue 1, and Blue 2 are all approved for use in the European Union. In fact, Europe approves more synthetic colors than the FDA does, including dyes like Carmoisine and Ponceau 4R that are not permitted in the United States.
The confusion stems from a regulatory decision made after the 2007 Southampton study, a UK-based research project that suggested mixtures of artificial food dyes triggered hyperactivity in some children. Following the study, the European Food Safety Authority (EFSA) reviewed the data and deemed it "not credible" as evidence for causation. The FDA's own advisory committee reached the exact same conclusion in 2011.
"This study got a lot of media attention, and politicians in Parliament decided that they were going to require a warning label anyway. It was a political decision to have a warning label, not a scientific one." — Dave Schoneker
Despite the scientific consensus, the resulting "banned in Europe" narrative continues to drive U.S. market demand for natural alternatives today.
The Red Dye 3 ban and the limits of FDA regulations
The disconnect between scientific evidence and regulatory policy is even more obvious when you look at how the U.S. handles its own additive bans.
In January 2025, the FDA banned Red Dye 3 (erythrosine) after decades of legal use. But the ban wasn't triggered by a new public health crisis. It was forced by the Delaney Clause, a rigid 1958 law that mandates an automatic ban on any food additive shown to cause cancer in animals—regardless of the dose, the mechanism, or the actual risk to humans.
In the 1980s, researchers fed rats massive doses of Red Dye 3 (4% of their total diet) and observed thyroid issues. But rats possess a specific hormone mechanism that humans do not. The thyroid effects were entirely specific to rat biology.
"FDA's own statement said they had no concern about the safety of Red 3 in humans. This was simply a Delaney issue. That clause doesn't allow them to use risk assessment and good science and toxicology to come to a conclusion." — Dave Schoneker
Meanwhile, Red Dye 3 remains legal in Europe and most countries worldwide. It’s a textbook example of how the same science, filtered through a different legal framework, produces a completely different outcome.
The unintended consequences of switching to natural food colors
Driven by regulatory battles and consumer pressure, many brands are rushing to replace synthetic dyes with "natural" alternatives. But the assumption that natural colors are inherently safer or more transparent ignores how the FDA regulates them.
Every single batch of synthetic dye produced in the U.S. must be certified by the FDA. Manufacturers are required to submit physical samples, and the agency tests them for purity and identity before they can be sold. Because they’re highly purified compounds, regulators know exactly what’s in them.
Natural colors—like carmine, annatto, or beet extract—are legally exempt from that certification process. The FDA doesn’t test them batch by batch. Because they are complex mixtures derived from nature, they vary from batch to batch, and they often contain trace elements that pure synthetics don't.
"Carmine is a significant allergen. You actually have to list carmine on the label. With all the other natural colors, you don't even have to list them. You can just say 'added color.'" — Dave Schoneker
Then there is the sheer scale of the supply chain. There is nowhere near enough natural color in the world to replace the synthetic dyes used in the U.S. Scaling up production to meet that demand would require a massive, unsustainable increase in agricultural acreage.
Following the science, not the headlines
The food industry is currently caught between consumer perception and scientific reality. But rushing to reformulate under political pressure or viral misinformation carries massive risks to food safety and transparency.
Schoneker's advice? Do not let panic dictate your supply chain.
While companies should absolutely begin evaluating natural alternatives and conducting technical studies, they should not rush to convert their entire product lines unless their specific target market demands it. The technical challenges and supply chain bottlenecks of natural colors are simply too significant to navigate without a clear, data-driven business case.
If you’re trying to separate fact from fear—and make formulation decisions based on actual science rather than headlines—this week’s conversation is essential listening.
This episode of Smarter Food Safety is available now, wherever you get your podcasts. To learn more about the host, Frank Yiannas, and why Ecolab is partnering on this show, read our profile here
Episode Field Notes
The Delaney Clause: The rigid 1958 legal provision discussed by Dave and Frank that forced the FDA to ban Red Dye 3. It mandates an automatic ban on additives shown to cause cancer in animals, preventing the FDA from conducting modern risk assessments for human safety: https://www.fda.gov/food/color-additives-information-consumers/color-additives-foods
Color Additive Certification: The rigorous batch-by-batch FDA testing required for synthetic dyes (like Red 40 and Yellow 5). Manufacturers must submit physical samples to guarantee purity and identity before these compounds enter the food supply: https://www.fda.gov/industry/color-certification/color-certification-faqs
Exempt Color Additives: Colors derived from natural sources (like beets or annatto) that bypass FDA batch certification. As Dave warns in the episode, these are complex mixtures that carry unique supply chain, purity, and batch-to-batch variability risks: https://www.fda.gov/industry/color-additives/color-additives-and-cosmetics-fact-sheet
Carmine and Allergen Labeling: A prime example of the unintended consequences of natural colors. Because carmine (derived from cochineal insects) is a documented allergen, the FDA requires it to be explicitly listed on labels, whereas other natural colors can hide behind the generic term "added color": https://www.fda.gov/food/color-additives-information-consumers/color-additives-questions-and-answers-consumers
Food & Beverage Processing Quality: Navigating complex formulation changes and regulatory shifts requires rigorous safety, quality, and operational controls. Learn how Ecolab supports food and beverage processors across the supply chain: https://www.ecolab.com/about/industries-we-serve/food-and-beverage-processing