Seeing Red-3

The FDA ban of Red Dye No. 3 will take place in 2027 for food applications, giving the food industry a two-year window to reformulate products. © Joni – stock.adobe.com

How Red Dye No. 3’s ban came to be and what it means for the packaging industry

By Michelle Briffett, a Principal with Roland Berger

On January 15, 2025, the FDA announced its decision to revoke the authorization of Red Dye No. 3’s for use in food and ingested drugs. The ban will take place in 2027 for food applications, giving the food industry a two-year window to reformulate products.

The FDA banned Red Dye No. 3 in response to a petition led by the Center for Science in the Public Interest (CSPI) in 2022. The petition centered on the the Delaney Clause, a law established in 1958 that mandates the FDA to ban any substance shown to cause cancer in humans or animals. A study conducted around 25 years ago linked Red Dye No. 3 to cancer in rats, leading the FDA to take action after its investigation confirmed the dye’s carcinogenic potential under the Delaney Clause.

While the FDA has banned Red Dye No. 3, it does not believe that the dye poses a significant cancer risk to humans at the levels typically consumed in food and beverages. The agency has highlighted that other studies have not produced similar results, and the dosage levels in the study that showed a cancer linkage far exceeded what humans would consume daily. Additionally, the FDA asserts that the biological mechanisms by which the dye induced cancer in rats do not exist in humans.

Understanding the Delaney Clause

The Delaney Clause presents a unique challenge for the FDA, as it does not account for dosage when assessing the safety of an ingredient from a carcinogenic standpoint. The phrase “the dose makes the poison” is well-known in toxicology, yet the Delaney Clause asserts that any detectable dose is unacceptable.

The Delaney Clause was established as part of the 1958 Food Additives Amendment to the Federal Food, Drug and Cosmetic Act. The Food Additives Amendement was foundational for the food industry, defining food additives and establishing safety assessments standards. At that time, concerns about cancer were rising in the country. At the same time, cancer research wasn’t developed and scientific methods weren’t capable of identifying specific exposure risk levels. The Delaney clause was set to prevent cancer causing substances from entering the food, drug and cosmetic supply.

In 1986, the FDA attempted to approve two color additives, Red Dye No. 19 and Orange Dye No. 17. The FDA argued that the Delaney Clause was archaic and the agency should take the risk-based assessment based on real-world circumstances. A panel of scientists from the US Public Health Service determined that the lifetime cancer risk posed by red dye was 1 in 9 million at worst and 1 in 19 billion for the orange dye. Ultimately, the panel determined that the level of risk was trivial. Despite the risk assessments, the court ended up ruling that the FDA must forbid the use of both dyes given studies that showed cancer-inducement in laboratory animals.

Moreover, many naturally occurring compounds found in fruits and vegetables, including vitamins and terpenes, have also been shown to induce cancer in animals at high dosages. The Delaney Clause’s strict application has led to the ban of certain ingredients, such as myrcene, a compound found in mangoes. The study underpinning this ban had a dosage level that was about 813,000 times higher than what is in the average American’s diet.

The Broader Picture on Red Dye No. 3

Concerns surrounding Red Dye No. 3 extend beyond cancer risk. Some studies have suggested a potential link between artificial food colors and attention-deficit/hyperactivity disorder (ADHD). In 2011, the FDA’s Food Advisory Committee concluded that there was insufficient evidence to establish a direct connection between food colors and ADHD in children. Nevertheless, activist groups remain vigilant, prompting California to ban several synthetic dyes — including Red Dye No. 3 — in school meals as of September 2024.

Moreover, Red Dye No 3. came under pressure in individual states starting with California passing a ban of Red Dye No. 3 alongside brominated vegetable oil, potassium bromate, and propylparaben in October 2023. New York, Pennsylvania, Missouri, Illinois, Maryland, New Jersey, Rhode Island, South Dakota, Washington and West Virgina followed suit in 2024 by proposing similar bans.

This increased scrutiny comes amid rising consumer concerns about the safety of food additives and the health implications of consuming “ultra-processed foods.” One of the hallmarks of these “ultra-processed foods” is the presence of food additives. Movements like “Make America Healthy Again” have intensified the spotlight on these additives.

Implications for Other Food Additives

The FDA’s ban on Red Dye No. 3, coupled with state-level actions, signals a potential shift in the regulatory landscape for food additives. Activist groups are likely to continue pressuring the FDA, utilizing the Delaney Clause to challenge the safety of various ingredients. The head of the U.S. Department of Human Health and Services, Robert F. Kennedy Jr., has called out an interest in reducing or eliminating artificial food colorings among other additives. This will add pressure to the FDA to reevaluate previously authorized ingredients.

However, whenever the FDA moves to ban an ingredient, it needs to be backed by scientific evidence and the law, as these decisions are likely to go to court.

Beyond the FDA, the activities in California and the states that followed demonstrate that states are now becoming more engaged in regulating additives within their borders. The states have different rules of engagement than the FDA and are able to ban ingredients without the same level of scientific and legal backing.

Going forward, the industry can expect continued pressure on food additives. Increased bans of food additives by the FDA are likely, but these bans can take time given the requirements for scientific review. What may impact the industry more immediately are the state level actions and overall consumer-sentiment around additives.

Preparing for the Future: Moving Beyond Red Dye No. 3

Red Dye No. 3 is commonly used in products such as ice creams, candies, and yogurts for its cost-effectiveness and appealing pink-ish color. The obvious first solution is to seek out a different approved synthetic color, however none of the colors is a perfect analog for Red Dye No. 3. For example, Red Dye No. 40 is a brighter red hue.

Food companies may need to consider reformulating their products with natural alternatives. While natural colors can be more expensive and may introduce challenges—such as flavor compatibility—they offer a proactive solution to align with consumer preferences and regulatory expectations.

As the landscape of food additives evolves, companies should conduct comprehensive evaluations of their product portfolios. The pressure on food additives is likely to intensify, and those who are best prepared for potential changes will be in a stronger position to safeguard their businesses. The Red Dye No. 3 ban is not an isolated incident; it represents a broader movement within the industry towards transparency, safety, and health-conscious reformulation.

About the Author

Michelle Briffett is a Principal with Roland Berger. With more than 10 years of international consulting experience, she has helped clients tackle strategic challenges, enter new growth sectors, complete complex M&A deals and transform their businesses. Michelle is a core member of the Materials and Process Industries team, focusing on food and beverages from ingredients to packaging to CPG. Her experience includes work in a diverse set of environments, with consulting clients in the US, Canada, Brazil, the Netherlands, Germany, Belgium, Denmark, the UK, China, Oman and Saudi Arabia. She has also coached entrepreneurs in North Macedonia, Russia and Moldova. Michelle received her Honors in Business Administration from Ivey Business School and her MBA from London Business School. Visit: https://www.rolandberger.com/en/Persons/Michelle.Briffett.html