Delaney Szwed

Associate Editor

Loyola University Chicago School of Law, JD 2023

Consumers read product labels regularly to educate themselves on ingredients they are putting on or in their body. More likely than not, most consumers have read a label before and seen “RED 3” as an ingredient, often listed at the end of the lengthy list. What most consumers fail to recognize is what exactly “RED 3” is and the potential hazard it can pose to their health. While the Food and Drug Administration has requirements in place restricting the use of this color additive in cosmetics, it is still permitted to be used in food and drug products despite scientific findings of its cancer-causing effects.

 

What is red dye no. 3?

Red Dye No. 3 is a synthetic dye derived primarily from petroleum that is used in food, drugs, and dietary supplements. This color additive gives a red tint to the product it is included in, often to make the product more attractive to the consumer. It is also used to correct natural variations in color, offset natural color loss, and provide color to colorless foods.

Current FDA regulations

The Federal Food, Drug, and Cosmetic Act states that a substance that emits color is considered to be a color additive and is subject to premarket approval requirements. In regard to Red Dye No. 3, under current law, the FDA’s regulationsrequire proof that it is safe at its intended level of use before it is added to a food product. When the color additive is approved by the FDA, its regulations specify the type of foods it can be used in, the maximum amounts allowable, and how to acknowledge the color additive on the food label. Furthermore, the FDA’s permitted food colors are separated into two categories: certification (human made dyes subject to batch certification) and exempt from certification (naturally derived dyes that do not need batch certification).

When evaluating whether a color additive should be approved, the FDA considers multiple factors: composition and properties of the substance, amount that would typically be consumed, immediate and long-term health effects, and availability of analytical methods for determining its purity and acceptable levels of impurities. Finally, the level allowable to be used in foods is typically limited to the amount that is necessary to achieve the desired color effect.

Historical hazard

In 1990, the FDA banned the use of Red Dye No. 3 in cosmetic products and topical drugs due to its cancer-causing effect on animals. Following this ban, the FDA stated it would need to take “separate action” to ban it in foods and supplements. If this was stated over 30 years ago, why is Red Dye No. 3 still permitted by the FDA to be include in products ingested by humans? Thomas Galligan, a PhD with the Center for Science in the Public Interest, declared that this “separate action” never came, and so consumers have been exposed to this cancer-causing color additive for decades. Today, more than 3,000 food products have Red Dye No. 3 as an ingredient.

Is anything being done?

Even though the issue of Red Dye No. 3 being allowable in food and drug products was greatly unacknowledged for many years, there has recently been some progression towards its prohibition. In October 2022, the Center for Science in the Public Interest (CSPI) and 23 other organizations petitioned for the FDA to remove Red No. 3 from the list of approved color additives in food and oral supplements. CSPI stated in its petition that the carcinogenic substance is used in many food and drug products which results in high exposure to young children. However, the FDA has since announced that they are “actively reviewing” the petition and the public comment period closed on April 18, 2023.

In more recent news, California just became the first state in the country to ban the use of Red Dye No. 3 (and other food additives) in consumer goods. Though this bill will not be implemented until 2027, it is a step in the right direction to ridding consumer products in the United States of this cancer causing substance.

Ultimately, the FDA owes a duty to consumers to uphold its promise of banning the use of Red No. 3 in food and supplements. However, as time goes on and the food and drug industry continues to develop, more products are being created that include Red No. 3. One way consumers can protect themselves from this carcinogenic substance is by thoroughly reading product labels and refusing to purchase those that contain Red No. 3 as an ingredient. But, if the FDA stands by its word, one day in the near future we will no longer see “RED 3” on any product labels in the United States.