On April 22, Health and Human Services (HHS) announced their plan to phase out all petroleum-based synthetic dyes from the nation’s food supply. This government-industry initiative to eliminate these dyes is driven by a populist movement more than scientific factors. Does this foreshadow a regulatory shift toward the Canadian and European approach based on the Precautionary Principle?
According to HHS Secretary Robert F. Kennedy, Jr.,
“For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent. These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development. That era is coming to an end. We’re restoring gold-standard science, applying common sense, and beginning to earn back the public’s trust.”
This is not “gold-standard” science, but the Make America Healthy Again (MAHA) movement that believes that all synthetic food additives, including food colors, are responsible for the rise in chronic diseases, including obesity, childhood diabetes, depression, autism, and childhood ADHD. Most scientists believe these diseases are multifactorial, caused by genetics, lack of exercise, environmental factors, and consuming excess calories. However, the MAHA movement’s demonization of food additives is becoming US government policy.
Some of the popular products that contain synthetic food colors include drinks (Gatorade, Mountain Dew), cereal (Froot Loops, Lucky Charms), candies (M&Ms, Skittles), snack food (Doritos, Cheetos), and some ice creams, frostings, and cake mix.
With $875 billion in sales in 2025, the US food industry has anticipated this trend, planning for the shift toward natural products long before Secretary Kennedy’s announcement. As stated in an analysis of the food coloring business, “dyes are out, with the trend towards using natural pigments to drive taste, texture, and color.” Therefore, it should come as no surprise that rather than fighting the government, the food industry is collaborating to phase out synthetic food colors. [1]
The HHS Phaseout
HHS plans to phase out six synthetic food colors [2] by the end of this year. They are also starting the process to revoke authorization for two additional synthetic food colors within the coming months and requesting food companies remove FD&C Red #3 sooner than the 2027-2028 deadline proposed in the January 2025 announcement.
The food industry has alternatives; more than 20 natural food colors are already approved by the FDA, including turmeric, paprika, annatto, elderberry, and beet juice. However, just because a product is natural does not mean it is safe. Even natural food colors, at very high doses, can be toxic. It is the dose that makes the poison!
Compared to synthetic food colors, a large amount of natural food color is required to obtain a less vibrant color that fades over time, particularly under heat and light. In many cases, the amount of natural food colors added is much closer to the Acceptable Daily Intake (ADI) than with synthetic food colors. Natural food colors are significantly more expensive to produce than artificial ones, which, along with a need for greater amounts, may cause a rise in food prices.
How are Food Colors Approved?
In the US, color additives are regulated differently from other food additives and are controlled more strictly. Color additives are divided into two groups: synthetically produced colors are certified, FD&C colors, while natural colors are exempt from certification. Manufacturers of certified food colors must submit samples of each batch to the FDA for testing and meet quality specifications. Because they are not certified, natural food colors do not undergo this degree of inspection.
New food colors, certified and non-certified, follow the same approval process:
- The manufacturer provides the FDA safety and toxicology data, including tests in rodents and cells, a list of all ingredients in the color additive, and an analytical method to measure the color additive.
- FDA scientists review the data and conduct a risk assessment, establishing an ADI based on the toxicological data and probable exposure levels.
The FDA determines a color additive is safe if “there is convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.” As required by the Delaney clause, no additive is considered safe if it is found to cause cancer in humans or animals.
Food additives in use before 1958, when Congress passed the Food Additives Amendment, were considered Generally Recognized as Safe (GRAS) by the FDA based on historical experience, and no further testing was required. Although the FDA does not allow food colors to be considered GRAS, the six food colors being phased out by HHS were “grandfathered” with limited testing required.
Europe and Canada
Europe and Canada follow the same general approach to approving food and color additives as the US. The main difference is that in Europe and Canada, risk assessment follows the Precautionary Principle:
“When an activity raises threats of harm to human health or the environment, precautionary measures should be taken even if some cause-and-effect relationships are not fully established scientifically.”
This requires decision-makers to take anticipatory action to prevent harm in the face of scientific uncertainty.
The US has not used the precautionary approach. Instead, the US uses a weight-of-evidence approach in risk assessment. This approach consists of assessment based on the totality of evidence rather than taking anticipatory action.
Different Approaches and Conclusions
In 2008, a study conducted at the University of Southampton in the UK suggested a link between a mixture of six food colors [3], the preservative sodium benzoate, and hyperactivity in children. The European Food Safety Authority (EFSA) concluded that the study:
“..provided limited evidence that the mixture of additives tested had a small effect on the activity and attention of some children. However, the effects observed were not consistent for the two age groups tested and the mixtures observed in the study.”
Using the Precautionary Principle, Europe concluded that this study, although limited, provided sufficient evidence to ban some of these food colors and add warning labels to the others. In examining the same Southampton study, the FDA concluded that there wasn’t enough evidence to prove that artificial food colors are associated with hyperactivity and did not restrict the use of or require warning labels for these food colors.
Another demonstration of the impact of the Precautionary Principle is that Europe has not approved all the natural food colors approved in the US, including:
- elderberry (a deep purple dye) because of its potential for contamination when raw
- spirulina (a blue-green dye made from algae) because it can become contaminated by metals
- carmine (a red dye) because of concerns about its source, cochineal insects, and potential allergic reactions.
“Why gamble with the health of our children? We have some data points. We have some observational studies. We believe that these artificial food chemicals are implicated. My feeling is, Why not err on the side of safety? Why say, ‘Let’s just take the risk because the vibrance of the colors is so appealing, it’s worth it.’”
- FDA Commissioner Martin Makary, MD
HHS is moving away from decisions based on the weight of evidence to the precautionary principle, where one non-conclusive study or anecdotal evidence outweighs the findings of many other well-done studies.
If this shift simply appeases the MAHA movement over food colors, it could be considered a one-off. However, adopting the precautionary principle across HHS and other government agencies will have a dramatic regulatory impact – an irony for an administration trying to reduce regulation because the precautionary principle results in more regulation and government intrusion.
[1] Secretary Kennedy has an “understanding” with large food manufacturers to eliminate petroleum-based dyes. The manufacturers' understanding is that they are open to a “conversation.”
[2] 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.
[3] Tetrazine, Quinoline yellow, Sunset yellow, Ponceau 4R, Allure Red AC, Carmoisine
