Trick or treat? Health organizations urge FDA to ban red dye number 3 in candies

27 Oct 2022 --- As Halloween approaches and parents worry about the amount of sugar their children will consume from candy, scientists and experts are claiming the real threat may actually be a known potential carcinogen used in some sweet treats: the color additive erythrosine – commonly known as red dye #3. Some professional and health-related groups are now calling for it to be banned in the US.

Though it has been illegal to use the color additive in cosmetics, makeup or externally applied pharmaceuticals since it was outlawed in 1990, the potentially carcinogenic chemical is still found in over 2,800 food items, including candies, cakes and seasonal items like those sold during Halloween according to Food Scores – a database run by the Environmental Working Group (EWG) that tracks ingredient listings in products.

The EWG and the Center for Science in the Public Interest (CSPI), along with 22 other professional and health organizations, are asking for the US Food and Drug Administration (FDA) to ban the chemical for use in food products.

“It’s outrageous that the Food and Drug Administration has known since the 1980s that Red 3 has the potential to cause cancer, but still allows it to be used in the food we eat,” says Melanie Benesh, vice president of government affairs at EWG. “This is yet another glaring example of how the FDA has failed consumers when it comes to food safety.”

“If the data were strong enough to ban Red 3 in cosmetics and external drugs 30 years ago, they’re surely strong enough to ban it today in foods, oral drugs and dietary supplements,” explains CSPI president, Dr. Peter Lurie.

A serious concern?
The original 1990 ban on the chemical for cosmetic and external use was the result of findings by the National Toxicology Program. It included many “provisionally listed” applications of the chemical but did not include internal applications. According to the CSPI, the FDA stated that it would take action to ban internal applications of the chemical as well, but never did.

The dye has been banned for use in cosmetics for decades but is still in many foods, like Halloween candies.However, the Secretary of Health and Human Services (HHS) at that time, Dr. Louis W. Sullivan, told the New York Times that the actual chances of getting cancer from the color additive is 1 in 100,000 within a lifetime of consumption. 

She added that, for context, the chance of being injured in a train accident or airplane crash is 6 in 100,000 and the odds of being injured in a natural disaster is 70 in 100,000. 

Moreover, the European Food Safety Authority found that the dangers were negligible and gave the erythrosine a daily safe intake level of 0.1 mg per kg of bodyweight per day. This means that a person weighing 80 kg could ingest about 8 mg a day. They further found carcinogenic effects after consuming 200 mg a day for 14 days.

“Halloween has never been the healthiest holiday, but few parents would believe that the FDA permits the use of a dye it acknowledges as a carcinogen to be used as a common ingredient in candy,” says CSPI consultant Lisa Y. Lefferts. “Fewer still would believe that the FDA prohibits this carcinogen in makeup but allows it in food.” 

Approximately 200,000 pounds of Red 3 was used in food and drug industry products in 2021. The EWG’s database found the chemical listed in 2,876 brand-name food products, including candies, instant foods and some pediatric nutrition drinks. 

Is it just a jump scare?
The experts are also citing years of research since the original ban, which supports the carcinogenic findings of the 1980s. Long-term studies have shown Red 3 to cause thyroid gland carcinomas and adenomas in animals. According to the CSPI, if a material is found to be cancerous or hazardous to animals, it is assumed to be cancerous or hazardous to humans.

The participating petitioning organizations state that this makes the FDA statutorily obligated to delist Red 3.” Yet, the FDA still lists the Red 3 as an approved ingredient for “ingested drugs” and for “foods generally.” The reason likely being that it has never been sufficiently proven to cause cancer in animals when ingested, only when externally applied. A former HHS Secretary said the odds of getting cancer from the dye are less than experiencing a plane crash.

“FDA has had more than 30 years to ban carcinogenic Red 3,” Tom Neltner of the Environmental Defense Funds underscores. “With this color additive petition, we are formally demanding that the agency do its job.” 

“The law gives the agency 180 days to make a final decision,” he continues. “Let’s hope that when kids go trick-or-treating next year, the FDA will have done its part to make the holiday safer for all.” 

“The primary purpose of food dyes is generally to make junk food look more attractive, especially to kids, or to trick their parents into thinking a food contains a healthy fruit like strawberries,” concludes Lurie. “When the purpose is purely cosmetic, why is any level of risk acceptable?”

By William Bradford Nichols