FDA bans Red No. 3 in food and drugs, manufacturers to reformulate by 2027

USA – The US Food and Drug Administration has banned the use of Red No. 3 in food and ingested drugs, a decision that will require manufacturers to reformulate their products within the next few years. 

According to the FDA, companies using the synthetic dye in food will have until January 15, 2027, while those using it in ingested drugs will need to comply by January 18, 2028. 

Red No. 3 has long been used to enhance the appearance of various products, including candy, baked goods, frozen desserts, and certain medications, giving them a bright, cherry-red color.

A report by the FDA cited the Delaney Clause, part of the Color Additives Amendment to the Federal Food, Drug, and Cosmetic Act, which prohibits the use of any food or color additive found to induce cancer in humans or animals.

The decision follows a 2022 color additive petition, which referenced studies indicating that high levels of Red No. 3 exposure led to cancer in laboratory male rats. 

However, the FDA emphasized that the mechanism causing cancer in male rats does not occur in humans and that exposure levels in people are significantly lower than those used in the studies. 

The agency stated that research involving other animals and humans did not show similar effects and maintained that available scientific data do not support claims that Red No. 3 poses a health risk to consumers.

The Center for Science in the Public Interest, one of the organizations behind the 2022 petition, described the ban as an overdue regulatory action. 

A statement from the CSPI noted that Red No. 3 had already been prohibited in topical drugs and cosmetics since 1990, when the FDA determined that the dye caused cancer in animals.

The organization criticized the delay in extending the ban to food, dietary supplements, and oral medications, arguing that the FDA had failed in its legal duty to remove cancer-causing additives from the market for more than three decades. 

The CSPI credited its petition for the eventual decision, which officially took effect on January 16, 2025.

According to reports, California had already taken steps to ban the sale of foods containing Red No. 3, with a state law set to come into effect on January 1, 2027. 

Industry observers suggested that the FDA’s nationwide action may have been influenced by concerns over inconsistent state-level regulations, as food manufacturers would have faced varying legal requirements across different regions.

Some stakeholders in the industry had expressed concerns that a patchwork of state laws could complicate compliance efforts, making federal regulation a more practical solution.

While some public health advocates welcomed the ban as a necessary step to eliminate potentially harmful additives, others in the industry pointed to the agency’s assessment that Red No. 3 does not pose a demonstrated risk to human health at typical exposure levels.