Are Color Additives Dangerous?

In 1950, children across the US suddenly started falling ill after eating a certain Halloween candy. It turned out that the candy contained a small amount of the color additive RD&C Orange No. 1, which caused the illnesses. That year, Representative James Delaney raised the issue of cancer-causing food additives, including color additives. Between these two events, the FDA decided to reexamine the list of approved color additives and found that several of them had some serious side effects that had never been taken into account.

Today still, many people try to avoid color additives (as well as other food additives), fearing that they may be less safe than people commonly believe. But does this thinking have any merit to it? After all, doesn’t the FDA stay on top of all food additives and make sure that they’re safe before allowing them to be used in foods?

The FDA and Color Additives

• The intended use of the substance
• How much of the substance people would likely consume
• The effect of the substance, cumulatively, on a person’s diet
• How to determine the purity of the substance, and which levels of impurity are acceptable
• Tolerances and limitations of the substance
• Safety studies that have been done on the substance
• Regulation requirements

According to the Code of Federal Regulations, a color additive can be termed “safe” only if there is “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use of the color additive.” In other words, competent scientists need to attest to the safety of the additive, based on the research that they have seen. 

“The concept of safety used in this legislation involves the question of whether a substance is hazardous to the health of man or animal,” explains Sebastian Cianci, a policy analyst at the FDA. “Safety requires proof of a reasonable certainty that no harm will result from the proposed use of an additive. It does not—and cannot—require proof beyond any possible doubt that no harm will result under any conceivable circumstances.”

The Threat of Carcinogens

Since some color additives in the past have been terminated from the “safe” list due to studies that show that they may cause cancer, the FDA is also careful to check color additives for carcinogenic (cancer-causing) properties. During the petition process, during which the petitioner describes various aspects of the color additive that has been suggested, the petitioner must specify safety data that has been collected about the additive, mostly through toxicity studies.

Toxicologists who review these studies may recommend that the special FDA committees reevaluate some of the toxicity studies, including carcinogenicity studies, included in the petition. They may also recommend that the color additive be studied more intensely by the National Toxicology Program (NTP), whose job is to evaluate substances that may post a danger to public health.