FDA Announces Plan to Phase-Out of Artificial Food Dyes

Following research that links artificial food dyes to certain cancers, neurological and developmental side effects, health officials will remove the products from the U.S. market by 2026.

Federal regulators have announced plans to phase out all petroleum-based food dyes from U.S. products by the end of next year, moving faster than previously expected, following a number of serious health risks linked to the artificial coloring.

In a press release issued on April 22, the U.S. Food and Drug Administration (FDA) outlined new initiatives aimed at eliminating certain synthetic food dyes from U.S. products, while promoting the introduction, and use of natural coloring alternatives.

Synthetic food dyes are found in many ultra-processed foods (UPFs), which have become a mainstay of American diets in recent decades. They include a number of petroleum-based dyes, including FD&C Green No. 3, FD&C Red No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, FD&C Blue No. 2, Citrus Red No. 2 and Orange B.

These kinds of petroleum-based food dyes have been linked to numerous adverse health consequences in recent years, including certain cancers, as well as a series of behavioral and developmental issues in children, such as hyperactivity, inattention and impulsivity.

As a direct response to concerns over the potential side effects of synthetic food colorings, the FDA has issued a new timeline for removing these dyes from the U.S. food supply and approving alternative natural dyes for use in food products.

The actions that the FDA intends to take include:

• Setting a nationwide guideline and schedule for the food industry to shift from petroleum-based dyes to natural alternatives
• Starting the process of withdrawing approval for two synthetic food dyes, Citrus Red No. 2 and Orange B, within the next few months
• Collaborating with the food industry to phase out six other synthetic dyes, Green No. 3, Red No. 40, Yellow No. 5, Yellow No. 6, Blue No. 1 and Blue No. 2, by the end of 2026
• Approving four other natural food color additives in the near future and expediting the evaluation of more natural options
• Partnering with the National Institutes of Health (NIH) to carry out in-depth studies on the effects of food additives on children’s health and development
• Urging food manufacturers to eliminate Red No. 3 from all foods prior to the previously established 2028 deadline, which was originally set in January of this year 

In addition, the FDA will be partnering with the U.S. Department of Health and Human Services’ (HHS) Nutrition Regulatory Science and Research Program to strengthen food dye regulations through enhanced nutritional research. The collaboration will include reviews of natural alternatives such as calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract.

“For too long, some food producers have been feeding Americans petroleum-based chemicals without their knowledge or consent,” HHS Secretary Robert F. Kennedy, Jr. said. “These poisonous compounds offer no nutritional benefit and pose real, measurable dangers to our children’s health and development.”

Ultra-Processed Food Risks

The petroleum-based food dyes targeted by the FDA are commonly found in colorful, ultra-processed foods that are heavily marketed to children.

Ultra-processed foods have become increasingly popular in recent decades, as manufacturers have marketed a wide variety of items made from highly refined ingredients and a mix of additives designed to replicate the flavor, look and feel of natural foods. They include sugary breakfast cereals, packaged frozen meals, sodas and other snack foods like chips.

However, these foods are often loaded with preservatives, artificial sweeteners and emulsifiers to enhance the product’s taste, texture and shelf life, while contributing little to no nutritional value. In addition, it now appears the food industry has known of potential health risks associated with these products for quite some time, but has continued to promote them to both adults and children.

Lawyers across the U.S. are now investigating potential ultra-processed food lawsuits for families of children diagnosed with type 2 diabetes or fatty liver disease, alleging that food manufacturers knowingly downplayed health concerns while prioritizing profits, by using marketing strategies that misled consumers and failed to warn about ultra-processed food dangers.