The U.S. Food and Drug Administration (FDA) announced a ban on the use of the synthetic color Red No. 3 in foods and ingested drugs. This measure comes more than 30 years after its use in cosmetics and externally applied products was restricted due to studies linking it to the development of thyroid cancer in animals.
Red No. 3, chemically known as erythrosine, is a color made from petroleum derivatives, known for providing a characteristic bright cherry-red hue to a wide range of products such as candy, cereals, cherries in syrup, and desserts.
Despite its popularity, the FDA’s decision responds to growing concerns about its potential health risks, although the agency clarified that the conditions that cause cancer in animals do not necessarily occur in humans, particularly due to the much lower levels of exposure in people.
Transition deadlines and scope of the measure
The regulation establishes that manufacturers will have until January 15, 2027, to reformulate foods containing Red No. 3, while ingested drugs must comply with the ban by January 18, 2028. In addition, products imported into the United States will also be subject to this regulation, resulting in a significant impact on the international food and pharmaceutical industries.
A change driven by public interest with implications for the food industry
The FDA’s decision is based on a petition filed in 2022 by organizations such as the Center for Science in the Public Interest and the Environmental Working Group, which argued that the scientific evidence regarding the color was sufficient to restrict its use. In addition, states such as California had already taken independent action by banning its use in foods as of October 2023, setting a precedent for other local legislation.
The elimination of Red No. 3 poses a challenge for manufacturers, who will need to seek safer alternatives and meet growing consumer demand for products free from synthetic additives. This opens the door to the development and incorporation of natural colors, which are not only safer but also align brands with trends toward healthier and more sustainable products.
The outlook in Latin America: Mexico removes erythrosine from the list of authorized colors
The regulatory landscape continues to evolve across the region. On May 28, 2026, Mexico’s Ministry of Health published an agreement in the Official Gazette of the Federation removing erythrosine and its lakes—also identified as Food Red 14, FD&C Red 3, or INS 127—from the list of colors authorized for use in foods, beverages, and dietary supplements.
The decision is based on an assessment by COFEPRIS, which estimated that dietary exposure to erythrosine in Mexico could exceed the acceptable daily intake established by JECFA by more than twofold.
The agreement came into effect the day after its publication and establishes a 24-month period for manufacturers to reformulate their products and use up existing inventories.
This transition will require ingredient replacement, process adjustments, the incorporation of additional equipment, and shelf-life studies to ensure that reformulated products maintain their quality, safety, functionality, and sensory attributes.
Toward a future without synthetic colors
The ban on Red No. 3 is an important step in protecting public health and reinforces the need to choose more natural and responsible ingredients. For manufacturers, it represents an opportunity to innovate and demonstrate their commitment to consumers by adapting to a market that is increasingly aware of the impact of artificial additives in the products we consume every day.
At Grupo Saporiti, we understand the importance of adapting to new regulations and responding to the demands of today’s market. We offer comprehensive solutions to replace erythrosine (Red No. 3) in a wide variety of products, either through permitted artificial colors or natural color options that improve consumer perception of the product.
Our team works alongside manufacturers to ensure that new formulations comply with regulations without compromising product quality or appearance, while providing differentiated value in a market increasingly focused on health and natural products.
