Red Dye No. 3 Gets The Boot: What You Need To Know About The FDA’s Decision
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- James M
- January 16, 2025
A major turning point in American food safety has been reached with the FDA’s recent decision to outlaw Red Dye No. 3 in food, beverages, and swallowed medications. For decades, the artificial ingredient, which is well-known for its vivid cherry-red hue, has been included into everything from baked goods and sweets to pharmaceuticals.
However, public health groups are pushing for Red Dye No. 3’s removal due to growing scientific evidence that it causes cancer in animals. This FDA decision is a long-awaited win for consumer health after years of discussion and delay.
Since research showed that Red Dye No. 3, also known as erythrosine, caused cancer in experimental animals in the 1980s, it has been the subject of attention.
The FDA’s Delaney Clause prohibited the ingredient from cosmetics and topical medications in 1990, but it was still permitted in food and swallowed medications, resulting in what experts have referred to as a “regulatory paradox.”
Red Dye No. 3’s safety was questioned despite its extensive use, exposing consumers to possible hazards for decades without their knowledge.
The significance of the prohibition goes beyond just eliminating one ingredient; it signifies a change in direction toward stricter food safety laws in the US. The European Union has already prohibited Red Dye No. 3 since 1994, and California’s 2023 ban paved the way for further legislation.
The Environmental Working Group and the Center for Science in the Public Interest are two advocacy organizations that have been instrumental in pressuring the FDA to take action, highlighting the growing national desire for safer and cleaner food options.
The FDA was forced to comply with the legal obligations under the Delaney Clause because Red Dye No. 3’s use in animal experiments showed carcinogenic effects at high doses, despite the lack of direct proof connecting it to cancer in people.
Manufacturers must reformulate items that contain the chemical by 2027, and imported foods must follow suit. In addition to protecting consumer health, this ruling serves as a warning to the food industry that the days of putting financial gain before of public safety are slowly ending.
Red Dye No. 3: What is it?
Erythrosine, sometimes referred to as Red Dye No. 3, is a synthetic colorant that is frequently used to give food, drinks, and pharmaceuticals a vivid cherry-red hue. This artificial dye, which comes from petroleum, has been widely used for decades in baked goods, candies, breakfast cereals, and even pharmaceuticals.
Its vivid and striking hue has established it as a mainstay in the food sector, particularly for products aimed at kids, who are frequently attracted to vibrant foods.
Over time, there have been serious health concerns about the usage of Red Dye No. 3. Studies conducted in the 1980s revealed a connection between the dye and cancer in lab animals, specifically male rats. Given that millions of consumers eat the chemical, these findings raised concerns about its safety.
The research was sufficient to identify Red Dye No. 3 as a possible carcinogen, even if it is thought that the mechanism by which the dye induced cancer in animals does not apply to people in the same way. The FDA nevertheless approved its usage in food products in spite of these reservations.
Remarkably, Red Dye No. 3 is already prohibited in non-food items. Under the Delaney Clause, which forbids the approval of chemicals that have been demonstrated to cause cancer in humans or animals, the FDA banned its use in cosmetics and topical medications in 1990.
Nonetheless, the dye continued to be permitted for use in food and consumed medications, resulting in what experts have called a “regulatory loophole.” For over thirty years, this discrepancy exposed consumers to the additive’s possible hazards.
A long-overdue step toward bringing food safety laws into line with current scientific knowledge was the FDA’s recent ban on Red Dye No. 3 in food and beverages. This decision underscores increased pressure from health campaigners and consumer demand for safer materials, even though the U.S. has lagged behind other nations, such the European Union, which banned the color in 1994.
Red Dye No. 3 will have to be eliminated from food goods by January 2027, which is a major win for public health and paving the way for cleaner substitutes.
FDA bans red dye No. 3 from food and ingested drugs in the US, more than 30 years after scientists discovered links to cancer in animalshttps://t.co/WEkQMCo7Oh
— CNN (@CNN) January 15, 2025
Why is Red Dye No. 3 currently prohibited?
After decades of pressure from advocacy organizations like the Environmental Working Group (EWG) and the Center for Science in the Public Interest (CSPI), the FDA finally decided to ban Red Dye No. 3. These groups have continuously brought attention to the dye’s dangers, such as its associations with cancer in animal research and possible behavioral impacts in kids.
Their efforts paid off in November 2022 when they filed an official petition requesting that the FDA act. Campaigns to raise public awareness and growing data about the dye’s negative effects generated enough momentum to compel regulatory reform.
The FDA took action in response to California’s 2023 decision to outlaw Red Dye No. 3 in food items. Historically, California has led the way in food safety changes, frequently enacting more stringent laws than those set forth by the federal government.
The state established a precedent that promoted national unity by outlawing the dye as part of a larger campaign against dangerous additives. The FDA’s countrywide prohibition guarantees uniformity throughout the U.S. food business and avoids any potential disputes between state and federal legislation, as several other states are contemplating similar prohibitions.
The Federal Food, Drug, and Cosmetic Act’s Delaney Clause is at the center of the dispute. This provision forbids the FDA from authorizing color additives that have been demonstrated to cause cancer in either people or animals.
Due to a regulatory loophole, Red Dye No. 3 was still present in food and swallowed medications even after the Delaney Clause of 1990 prohibited its use in cosmetics and topical medications. Despite abundant evidence of its carcinogenicity in animal studies, the FDA maintained that the mechanism causing cancer in animals did not apply to people and permitted its continuing use in foods.
FDA bans red dye No. 3 from food and ingested drugs in the US, more than 30 years after scientists discovered links to cancer in animalshttps://t.co/U4maD5N163
— CNN Breaking News (@cnnbrk) January 15, 2025
Red Dye No. 3’s possible health hazards have been the subject of ongoing research. Animal cancer has been clearly linked to the dye in numerous studies, especially when large doses are used. These results, which were initially discovered in the 1980s, raised concerns about Red Dye No. 3’s carcinogenic potential because they showed that it induced tumors in lab rats, particularly male rats.
Red Dye No. 3’s long-term persistence in foods raised concerns, despite the FDA’s initial dismissal of these findings, stating that the mechanism causing cancer in animals might not apply to people. The decision to outlaw the dye was viewed as a critical step in safeguarding the health of consumers, especially in light of recent advocacy and more research demonstrating its detrimental consequences.
Red Dye No. 3 has been connected to behavioral and attention problems in youngsters in addition to the risk of cancer. Artificial food coloring and attention deficit hyperactivity disorder (ADHD) may be related, according to some research.
For example, studies have shown that eating foods containing Red Dye No. 3 or other food dyes may make ADHD symptoms worse or make sensitive kids more impulsive. Given that synthetic dyes are frequently used in snacks, candies, and beverages aimed at younger consumers, this has sparked worries about the pervasive use of these additives in children’s food products.
The current safety criteria for food dyes may not completely protect children’s health, according to other studies. According to a 2021 study by California’s Office of Environmental Health Hazard Assessment, the regulatory limits for food dyes that were established decades ago are not high enough to protect children’s brain development.
New scientific research on the neurotoxic potential of artificial food colors was not taken into consideration by these antiquated regulations. Experts contend that more laws are required to address the cumulative consequences of ingesting Red Dye No. 3 and other food colorings, especially when it comes to young children’s diets.
The U.S. has been hesitant to enact restrictions that are comparable to the European Union’s more cautious approach. Based on the precautionary principle, which holds that protective action shouldn’t be delayed in the absence of total scientific confidence, the EU outlawed Red Dye No. 3 and other artificial colorings in 1994.
The United States, on the other hand, has permitted these chemicals to continue to be present in food items in spite of growing evidence of their possible hazards.
Health advocates, who contend that U.S. regulations should change to better protect public health, have criticized this delay in addressing concerns about synthetic dyes like Red Dye No. 3. This is especially true when there is evidence that these substances pose risks to vulnerable populations, such as children.
The U.S. has been hesitant to enact restrictions that are comparable to the European Union’s more cautious approach. Based on the precautionary principle, which holds that protective action shouldn’t be delayed in the absence of total scientific confidence, the EU outlawed Red Dye No. 3 and other artificial colorings in 1994.
The United States, on the other hand, has permitted these chemicals to continue to be present in food items in spite of growing evidence of their possible hazards. Health advocates, who contend that U.S. regulations should change to better protect public health, have criticized this delay in addressing concerns about synthetic dyes like Red Dye No. 3. This is especially true when there is evidence that these substances pose risks to vulnerable populations, such as children.
Reading ingredient labels closely is one of the best strategies to stay away from Red Dye No. 3. This dye must be listed by food makers under designations like “Red 3” or “FD&C Red #3.” Customers may easily recognize and steer clear of products that contain the dangerous ingredient by learning these terms.
These goods will be altered once the FDA’s restriction takes effect, but in the meantime, it’s crucial to read labels to make educated decisions, particularly when purchasing kid-friendly snacks, sweets, or beverages.
Selecting whole, natural foods versus ultraprocessed ones—which are more likely to include artificial colorants like Red Dye No. 3—is another useful advice. In addition to being devoid of artificial coloring, whole fruits, vegetables, grains, and proteins offer consumers a more wholesome and nutrient-dense choice.
A variety of additives, such as artificial colors, are frequently used in processed foods to enhance its color, flavor, and shelf life. People can improve their overall diet and drastically lower their exposure to dangerous substances by concentrating on fresh, minimally processed foods.
Products that use natural coloring substitutes are another option for customers who are very worried about food dyes. Nowadays, a lot of businesses are using mineral and plant-based dyes instead of artificial additives like Red Dye No. 3 to produce vivid hues.
Beet juice, turmeric, and paprika are common natural substitutes that are frequently used to produce red, yellow, and orange hues, respectively. Due to consumer desire for cleaner materials, these natural colors are becoming more commonly available and are usually thought to be safer.
In addition to food, it’s critical to look for artificial coloring in pharmaceuticals. A lot of over-the-counter medications, particularly liquids and chewables, contain colorants like Red Dye No. 3. Customers should contact their healthcare professional for dye-free options or study the “inactive ingredients” section on packaging to steer clear of these additives.
Before changing prescriptions, it’s important to speak with a doctor because some formulations could need specific additives for stability or effectiveness. The cumulative impact of artificial dyes, including Red Dye No. 3, on health can be harmful, especially for youngsters and people with food coloring sensitivity, according to experts.
An important step toward bolstering food safety regulations in the US has been taken with the FDA’s Red Dye No. 3 ban. Health advocates, experts, and consumers have been raising concerns about artificial food dyes’ possible health dangers for decades, including links to cancer and behavioral problems.
As the FDA works to address long-standing health dangers, the prohibition represents a growing acknowledgment of the need for stricter regulation of food additives. As this lawsuit progresses, it may open the door for stricter regulations on additional hazardous compounds, signaling a change in emphasis from industry interests to public health.
Additionally, the prohibition shows an increasing adherence to global food safety regulations, especially those of the European Union, which outlawed Red Dye No. 3 in 1994. The United States is progressively catching up to international standards and embracing a more cautious approach to food safety by enacting measures to limit the use of this hazardous coloring.
The precautionary principle—acting to safeguard public health despite scientific uncertainty—was the foundation of the EU’s prohibition, but the U.S. has sometimes been slower to enact such laws, partly due to business lobbying. In keeping with international norms for food safety, the FDA’s decision to outlaw Red Dye No. 3 suggests a possible move toward more aggressive control.
Experts like Dr. Jennifer Pomeranz, however, have criticized the FDA for its tardy response to Red Dye No. 3, claiming that the agency should have taken action in the 1990s when the dye’s carcinogenic hazards in animals were first discovered. The shortcomings in the FDA’s approach to food safety are highlighted by the regulatory gaps that permitted dangerous compounds to persist in the food chain for decades.
There are increasing calls for a comprehensive revamp of the food safety regulatory system to enable faster, more responsive action on developing health hazards, as Pomeranz and others have noted that the FDA’s inaction has cost the public years of exposure to potentially dangerous additives.
This prohibition also fits within a larger public health framework where overall health outcomes in the United States are declining. There is mounting evidence that the prevalence of chronic diseases including obesity, diabetes, and heart disease is on the rise due to poor diet and excessive intake of ultraprocessed foods.
These meals frequently include dangerous dyes like Red Dye No. 3 and other artificial additives. The stalling of significant food safety reforms has been caused by the popularity of these goods in the American diet as well as corporate lobbying that impedes regulatory action.
Red Dye No. 3’s recent ban is a significant move, but it also emphasizes how urgently additional funding for food safety studies and stricter laws are needed to safeguard public health in the face of a highly processed food environment.