Introduction to the Controversy
The FDA’s decision to ban red dye No. 3 in food and ingested drugs has sparked controversy, with the agency citing a 1987 study on rats to support its action. The study, led by Virginia toxicologist Joseph Borzelleca, found that the petroleum-derived food coloring doesn’t cause cancer in humans. However, the FDA examined the data and reached its own conclusion: that the dye causes cancer in male lab rats.
Background on Red Dye No. 3
Red dye No. 3, also known as FD&C Red No. 3, has been used in foods since 1907. It is an ingredient in thousands of products, including cereals, candy, beverages, and cake toppings. The International Association of Color Manufacturers says Red 3 is safe in the tiny levels typically consumed by humans. However, consumer advocacy groups have long pushed for a ban, citing concerns over the dye’s potential health effects.
The Study and Its Findings
Borzelleca’s study, funded by the International Association of Color Manufacturers, found that some rats fed Red 3 developed polyps in their thyroid gland, but did not mention cancer. The study was a response to the FDA’s requirement in the 1980s for additional long-term feeding studies in rats and mice as a condition for the continued provisional approval of several color additives, including Red 3. Borzelleca, now 94, stands by the conclusions in his paper, stating that he has no problem with his family consuming Red 3.
FDA’s Decision and Industry Response
The FDA’s decision to ban Red 3 in cosmetics in 1990 and its recent announcement to ban the dye in food and ingested drugs have been met with criticism from the industry. The International Association of Color Manufacturers points to research by scientific committees operated by the World Health Organization, including a 2018 review that affirmed the safety of Red 3 in food. Some food manufacturers have already reformulated products to remove Red 3, using alternative ingredients such as beet juice, carmine, and pigments from foods like purple sweet potato, radish, and red cabbage.
Global Regulations and Consumer Concerns
The European Union, Australia, and Japan are among the locations that already ban Red 3 in foods, citing concerns over hyperactivity in children. California became the first state to ban Red 3 in food starting in 2027, superseding the FDA’s earlier rule allowing small amounts in foods as a color additive. Consumer advocacy groups, such as the Center for Science in the Public Interest, have cheered the FDA’s decision, stating that federal law is clear: no amount of cancer risk is acceptable in foods.
Conclusion
The controversy surrounding Red 3 highlights the ongoing debate over the safety of food additives and the role of regulatory agencies in protecting public health. While the FDA’s decision to ban Red 3 has been met with criticism from the industry, consumer advocacy groups argue that the dye’s potential health effects, including hyperactivity in children, warrant its removal from the food supply. As the food industry continues to evolve, it is likely that the debate over food additives will remain a contentious issue.
FAQs
- What is Red ye No. 3 and what is it used for?
Red dye No. 3, also known as FD&C Red No. 3, is a petroleum-derived food coloring used in thousands of products, including cereals, candy, beverages, and cake toppings. - What are the potential health effects of Red 3?
Some studies have suggested that Red 3 may cause hyperactivity in children, while others have raised concerns over its potential carcinogenic effects. - Why did the FDA ban Red 3 in food and ingested drugs?
The FDA cited a 1987 study on rats, which found that the dye causes cancer in male lab rats, as the basis for its decision to ban Red 3. - What alternatives are available to Red 3?
Some food manufacturers have already reformulated products to remove Red 3, using alternative ingredients such as beet juice, carmine, and pigments from foods like purple sweet potato, radish, and red cabbage. - What is the current regulatory status of Red 3 globally?
The European Union, Australia, and Japan are among the locations that already ban Red 3 in foods, while California has become the first state to ban the dye in food starting in 2027.
