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FDA says it causes cancer. Yet it’s in hundreds of candies.
In October 2022, scientists and advocacy groups petitioned the FDA to ban Red 3 — a dye already illegal in cosmetics — from foods, oral drugs and supplements.
It’s illegal to use the carcinogenic color additive Red 3 in cosmetics, such as lipstick or blush, or in externally applied drugs. Yet in 2022 the discredited dye was still lurking in common varieties of candy corn, Nerds, Peeps, Pez, SweeTarts and hundreds of other candies, cakes and foods — including dozens of seasonal Halloween items.
That’s why, in October 2022, the Center for Science in the Public Interest (CSPI), 23 other organizations and prominent scientists urged the Food and Drug Administration to formally remove Red 3 from the list of color additives approved for foods, dietary supplements and oral medicines. This article is adapted from CSPI’s press release.
The short version
- Red 3 was removed from cosmetics and externally applied drugs in 1990, after evidence that it caused cancer in laboratory animals.
- In 1990 the FDA also said it would “take steps” to ban Red 3 from foods, ingested drugs and supplements — but those steps were never taken.
- A search of EWG’s Food Scores database found 2,876 brand-name foods containing Red 3, and industry used more than 200,000 pounds of it in 2021.
- The 2022 petition argued that the Delaney Clause legally obligates the FDA to delist the dye.
- CSPI’s advice to parents: avoid all numbered dyes, such as Yellow 5 and Red 40, not only Red 3.
Known Since the 1980s
The FDA had evidence since the early 1980s that Red 3 caused cancer in laboratory animals, and the National Toxicology Program considered that evidence “convincing.” As a result, in 1990 the agency eliminated certain “provisionally listed” uses of the chemical — in cosmetics and externally applied drugs. That same year, the FDA said it would “take steps” to ban its use in foods, ingested drugs and supplements. Those steps were never taken.
“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. Fewer still would believe that the FDA prohibits this carcinogen in makeup but allows it in food.”
— Lisa Y. Lefferts, CSPI consultant
Where Red 3 Shows Up
Even though the government concluded that Red 3 causes cancer, food companies continued to use it widely. A search of Food Scores, a database maintained by the Environmental Working Group, turned up 2,876 brand-name food products containing Red 3, including hundreds made by the country’s biggest food companies. At the time of the petition:
- Candy company Brach’s alone sold more than 100 different candies with the dye.
- Besides Pez and Peeps, Red 3 was used in some varieties of Betty Crocker’s Fruit by the Foot, Dubble Bubble chewing gum, Entenmann’s Little Bites and Hostess’ Ding Dongs.
- Albertsons, Kroger, Meijer, Target and Walmart all used Red 3 in some of their house-brand products.
- It turned up in foods you wouldn’t expect to need artificial color, such as Betty Crocker’s Loaded Mashed Potatoes.
- Sometimes it stood in for a desirable ingredient. Vigo Saffron Yellow Rice does contain some famously expensive saffron, but it got at least some of its color from Red 3. And PediaSure Grow & Gain Kids’ Ready-to-Drink strawberry shake contained Red 3 — but no strawberries.
In all, the food and drug industries used more than 200,000 pounds of Red 3 in 2021 alone.
What the Law Says
Long-term animal feeding studies show that Red 3 causes adenomas and carcinomas of the thyroid gland. When a substance is shown to cause cancer in animals, it is presumed to cause cancer in humans.
Amendments to the nation’s food laws passed in 1958 and 1960 include a provision called the Delaney Clause, which prohibits the approval of any food or color additive shown to cause cancer in people or animals. For that reason, the petition argued that the FDA is statutorily obligated to delist Red 3.
“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. This is yet another glaring example of how the FDA has failed consumers when it comes to food safety.”
— Melanie Benesh, vice president of government affairs, EWG
“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.”
— Dr. Peter Lurie, CSPI president
Once a color additive petition is filed, the clock starts: the FDA has 180 days to make a final decision.
“FDA has had more than 30 years to ban carcinogenic Red 3 — an artificial food color used in many products, including the candy people will be giving out this Halloween. Is the agency red in the face? Not at all. 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. Let’s hope that when kids go trick-or-treating next year, FDA will have done its part to make the holiday safer for all.”
— Tom Neltner, Environmental Defense Fund
Beyond Red 3: Other Numbered Dyes
CSPI’s advice to parents is to avoid not just Red 3 but all numbered dyes, such as Yellow 5 and Red 40. Besides the cancer risk posed by Red 3, concerns have mounted about food dyes’ effects on children’s behavior. In 2008, CSPI petitioned the FDA to remove those dyes from the food supply as well, and since then California’s Office of Environmental Health Hazard Assessment has confirmed that they cause neurobehavioral problems in some children.
Despite the risks, some prescription drugs contained Red 3 too. Vyvanse, billed as the “#1 prescribed branded ADHD medication,” contained it. According to CSPI, that’s somewhat ironic, since the behavioral problems associated with food dyes are often described as similar to the symptoms associated with ADHD.
“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. When the purpose is purely cosmetic, why is any level of risk acceptable?”
— Dr. Peter Lurie, CSPI president
Who Signed the Petition
Besides CSPI, the Environmental Defense Fund, EWG and Lisa Lefferts, the petition was submitted by Breast Cancer Prevention Partners, Center for Environmental Health, Center for Food Safety, Chef Ann Foundation, Children’s Advocacy Institute, Consumer Federation of America, Consumer Reports, Defend Our Health, Feingold Association, Food & Water Watch, Healthy Babies Bright Futures, Life Time Foundation, MomsRising, Prevention Institute, Public Citizen, Public Health Institute, Public Interest Research Group and Real Food for Kids.
Individual scientists who signed include Linda S. Birnbaum, former head of both the National Institute of Environmental Health Sciences and the National Toxicology Program, and pediatrician and epidemiologist Philip J. Landrigan of Boston College, who directs both the Program for Global Public Health and the Common Good and the Global Observatory on Planetary Health.
Sources
- Center for Science in the Public Interest — “FDA says it causes cancer. Yet it’s in hundreds of candies.” (press release; this article is adapted from it). cspinet.org
- CSPI and co-petitioners — Red 3 color additive petition
- CSPI — 2008 petition to the FDA on food dyes
- California Office of Environmental Health Hazard Assessment — Synthetic food dye risk assessment
- Environmental Working Group — Food Scores: Red 3
- Vyvanse medication guide
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