Shifting Shades in the Food Industry

“Many people have a knee-jerk reaction to the word petroleum, especially related to food, but it’s just that hydrogen and carbon are the building blocks chemists use to create other compounds.”

In April 2025, The U.S. Food and Drug Administration (FDA) announced plans to phase out eight synthetic food colorings by the end of 2026, including revoking authorization of two rarely used colors, Citrus Red No. 2 and Orange B, and asking for voluntary removal of six others including FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2.

Why is this happening now? What’s driving the shift and what does the science say? And how will the food industry respond? To better understand these regulatory changes and their impact on our clients, we spoke with Dave Schoneker, a veteran expert with more than 48 years of experience in food and color additives and the regulatory landscape that governs them.

Thanks for talking to us, Dave. Can you briefly explain what constitutes synthetic versus natural additives or dyes?

Natural color additives come from plants, animals, or minerals. Synthetic dyes are made from organic chemical compounds derived, way down the chain, from petroleum. Many people instinctively react negatively to the word petroleum in connection with food, but it simply refers to hydrogen and carbon as the building blocks of other compounds, the same elements used to create most medicines and dietary supplements. None of these products contain any petroleum.

What are the latest regulatory developments? Are synthetic dyes banned? Is the US just following suit with Europe’s earlier actions?

The FDA has banned FD&C Red No. 3 starting in January 2027. They also recently asked companies to voluntarily remove six additional synthetic food colorants, identified above, though none of those are formally banned.

A common misperception is that Europe has a long list of banned syn[1]thetic dyes still in use in the U.S and this is simply not true. Europe follows a precautionary principle approach, restricting additives whenever any potential hazard is identified, regardless of whether or not there is any real safety risk. None of the FD&C synthetic dyes approved in the U.S. are banned in Europe.

A few require a warning label based on a political decision, not supported by the European Food Safety Authority (EFSA). In contrast, the U.S. permits dyes, only after thorough scientific evaluations coupled with modern risk assessments confirm that they are safe to use for specific intended uses and exposure levels. Meanwhile, we’re seeing states such as Texas, California, and West Virginia develop their own regulations based on misinformation about the status of these FD&C dyes in Europe, although some defer to FDA regulation, which can preempt state level bans.

Schoneker believes the growing patchwork of state initiatives may face significant legal headwinds. Under California’s Safe Drinking Water and Toxic Enforcement Act (Prop 65), products containing carcinogens or reproductive toxins must carry a “clear and reasonable warning.” When titanium dioxide (TiO2) was added to that list, consumer groups called for warning labels on beauty and personal care products. However, in a recent California court case, Personal Care Products v. Bonta, a California court issued a permanent injunction, rulingthat compelling cancer warnings for cosmetic and personal-care products violated the First Amendment because the scientific evidence did not support that titanium dioxide is a human carcinogen, and the warning was not “purely factual and noncontroversial.”

Similar state-mandated warnings for synthetic food and color additives may soon face legal challenges. On October 6, the International Association of Color Manufacturers (IACM) filed a lawsuit in the U.S. District Court for the Southern District of West Virginia, seeking to overturn a new state law banning certain food colors and ingredients. The IACM argues the law infringes on the FDA’s authority over food safety, disrupts interstate commerce, and imposes unwarranted economic harm without any scientific basis for deeming the products unsafe.

Let’s dive into Red No. 3. Why is that banned?

FD&C Red No. 3 is being banned based upon a recent petition from consumer advocate groups that invokes The Delaney Clause. The Delaney Clause is a provision in the 1958 Food Additives Amendment that prohibits the FDA from approving any food additive that has been found to cause cancer in humans or animals. On principle, that makes a lot of sense. We don’t want carcinogens in our food supply.

In 1958, toxicological risk assessments were far less advanced than today. The ban stems from a study I worked on in the 1980s where rats were fed various doses of Red No. 3. An indication of a thyroid tumor appeared only at the highest exposure level, where 4% of the rats’ total diet consisted of pure dye. At that level, the rats literally turned bright red because they were eating so much dye.

Humans could never consume that much dye, and they lack the hormone that triggered the tumors. The FDA didn’t initially ban the dye, because it concluded there was no risk to people. Still, under the Delaney Clause, regulators have no flexibility to apply modern risk assessment tools that account for dosage or other mitigating factors.

What science is backing these changes?

There is no credible scientific evidence that supports a causal link between synthetic dyes and health problems.

One of the most frequently cited studies linking synthetic dyes to ADHD and hyperactivity in children is the Southampton study from 2007. However, both the European Food Safety Authority and the FDA reviewed the study and concluded that its design was flawed, and its results could not be replicated in subsequent less biased research.

Despite this, the study received significant press coverage, leading European lawmakers to require warning labels on products that used specific synthetic dyes. Most companies chose to voluntarily replace the ingredients or no longer sell certain products in Europe rather than carry a warning label.

To most consumers, it seems common sense that natural should be better than synthetic chemical compounds. What would you say to them?

Debate around synthetic color additives is often driven by emotion. As a parent, I understand—we all want to protect our kids. But everything carries some level of risk, and it’s the job of expert toxicologists and regulators to evaluate the magnitude of the risk. A standard rule in toxicology is that the dose makes the poison. Even water, at high enough levels, can be toxic.

Synthetic colors are among the most thoroughly studied additives in the world, while safety data on many natural colorants remains limited. For example, carmine, a natural red colorant derived from the cochineal insect is a known allergen, but most people haven’t been widely exposed to it. However, very few people are allergic to synthetic dyes.

“Synthetic colors are among the most thoroughly studied additives in the world.”

On top of that, every single batch of synthetic colors undergoes testing by the FDA, and the same isn’t true for natural colors. Safety is based on the specific toxicology of the chemical itself, not what it was derived from. Therefore, being naturally derived doesn’t make anything inherently safer than something which is synthetically derived. This is a common misunderstanding that many consumers have.

What challenges may manufacturers experience if they switch from synthetic to natural dyes?

Manufacturers will face a host of challenges moving away from synthetic additives. The first is formulation and consistency. Synthetic colors are produced under controlled conditions, making them highly uniform in quality and purity. Natural colors are more prone to variability. Think of beet extract. Things like soil, weather, and the way beets are processed can impact the color.

Natural ingredients also have stability issues related to light, heat, and pH, and their color can shift noticeably with changes in acidity or alkalinity. Going back to the beet example, it appears red, but when heated it turns brown.

Changes due to pH can be difficult to manage because many natural colorants shift hue under small fluctuations. As Dave explained, “a pigment might appear red in an acidic beverage, purple at neutral, and blue in a basic formulation.” Many food systems aren’t tightly controlled for pH, which could lead to slight variations in appearance from batch to batch. “Synthetic colors are typically ninety to ninety-four percent pure dye with a consistent compositional profile,” he noted, “while natural pigments may contain minor components that vary seasonally, requiring more reformulation and testing to maintain consistency.”

Another major challenge is the supply chain. Since many natural colors are derived from plants or animals, the current agricultural infrastructure is not in place to supplant synthetic colors with natural colors and will not be in place anytime soon. This also causes significant cost differences between natural and synthetic colors. Carmine, which we discussed earlier, is approximately $600-$800 a kilo while FD&C Red No. 3 dye is approximately $30- $50 a kilo. Finally, adulteration is a concern. As demand for natural ingredients increases, more small suppliers will enter the market, and some may cut corners for the sake of profit.

As companies start to react to this new FDA request, strategies vary. Some are voluntarily complying as requested, while others are pushing back. In some cases, manufacturers are keeping their existing formulations but also introducing natural versions of products to meet consumer demand.