US FDA Bans Red Dye 3 in Foods and Drugs Amid Safety Concerns

Jan 15, 2025 at 4:53 PM

The United States Food and Drug Administration (FDA) has recently announced the revocation of authorization for red dye 3, an artificial coloring agent commonly used to impart a vibrant red hue to various food products. Effective from January 15, this decision marks a significant shift in food safety regulations, following California's earlier ban on the substance within its borders. The additive has long faced criticism over potential health risks, leading many manufacturers to preemptively remove it from their offerings. Despite these actions, red dye 3 remains present in certain foods across the country. This article explores which products still contain the dye and delves into the reasons behind its prohibition.

The synthetic dye, also known as erythrosine, is derived from petroleum and has been utilized for decades to enhance the visual appeal of numerous food items. However, concerns about its safety have persisted. In 1990, the FDA banned red dye 3 from cosmetics and topical medications under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act), which prohibits color additives shown to cause cancer in animals or humans. While animal studies have indicated potential carcinogenic effects at high doses, no definitive link has been established in human studies.

Despite the lack of conclusive evidence regarding cancer risk in humans, experts like Wade Syers, a food safety specialist at Michigan State University Extension, acknowledge that the ban aligns with existing legislation prohibiting substances linked to cancer in any species. Moreover, Scott Keatley, a registered dietitian and co-owner of Keatley Medical Nutrition Therapy, emphasizes that red dye 3 offers no nutritional or functional benefits to food beyond its coloring properties.

Several popular food categories continue to contain red dye 3, including baked goods decorations, ice cream cones, frostings, frozen dairy desserts, soft candies, meal replacement drinks, cookies, toaster pastries, ice pops, baby foods, and hard candy. Manufacturers have until January 15, 2027, to phase out the use of this additive. For those concerned about potential health impacts, particularly on children, checking ingredient labels can help avoid exposure to red dye 3. Some studies suggest a correlation between food dyes and behavioral issues in kids, though opinions vary on the significance of these findings.

While the ban reflects precautionary measures based on regulatory guidelines, it underscores the ongoing debate surrounding artificial food additives. Consumers are advised to stay informed and make choices that align with their health priorities. The gradual removal of red dye 3 provides ample time for manufacturers to adapt, ensuring a smoother transition to safer alternatives without immediate cause for alarm.