Outgoing US President Joe Biden’s administration on Wednesday announced a ban on Red Dye No 3, a controversial food and drug coloring long known to cause cancer in animals.
Decades after scientific evidence first raised alarm, Red 3, as it is also called, is currently used in nearly 3,000 food products in the United States, according to the nonprofit Environmental Working Group.
“FDA is revoking the authorized uses in food and ingested drugs of FD&C Red No 3 in the color additive regulations,” said a document from the Department of Health and Human Services, published in the Federal Register on Wednesday.
The decision stems from a petition filed in November 2022 by the Center for Science in the Public Interest (CSPI) and other advocacy groups, which cited the “Delaney Clause” – a provision mandating the prohibition of any color additive shown to cause cancer in humans or animals.
Notably, the FDA determined as early as 1990 that Red 3, whose chemical name is erythrosine, should be banned in cosmetics because of its link to thyroid cancer in male rats.
However, the additive continued to be used in foods, largely due to resistance from the food industry. Manufacturers of maraschino cherries, for example, relied on Red 3 to maintain the iconic red hue of their products.
It’s also present in thousands of candies, snacks and fruit products – and thousands of medicines, according to a search of a government-run database, DailyMed.
“Manufacturers who use FD&C Red No 3 in food and ingested drugs will have until January 15, 2027, or January 18, 2028, respectively, to reformulate their product,” the FDA said.
Although the agency acknowledged a cancer link in rats, it maintained that the available evidence does not support such a link in humans, citing differences in hormonal mechanisms between the species and significantly lower exposure levels in people.
While the FDA determination focused on carcinogenicity, other research has also found potential neurobehavioral effects of synthetic food dyes on children, notably Attention-Deficit/Hyperactivity Disorder (ADHD).
Animal studies indicated that synthetic food dyes caused changes in neurotransmitter systems in the brain and produced microscopic changes in brain structure, affecting activity, memory and learning.
The United States has been slow to act on Red 3 compared to other major economies. The European Union banned its use in 1994, with similar prohibitions enacted in Japan, China, the UK, Australia, and New Zealand.
Carl Tobias, a former FDA legal consultant and now a professor at the University of Richmond, told AFP it was “hard to square” the agency’s mission of protecting American health with the prolonged delay in reaching the decision. “There’s pretty extensive lobbying, there always has been, and some of it is sometimes effective,” he said, calling the ban a “step in the right direction.”
CSPI also hailed the FDA’s decision as long overdue, and expressed hope that it would pave the way for broader action on other harmful chemicals in food. “They don’t add any nutritional value, they don’t preserve the food – they’re just there to make food look pretty,” Thomas Galligan, a scientist with CSPI, told AFP.
All the concern about this dye is based on a 1990 study where they fed rats 0.5%, 1%, or 4% of their diet by mass with the dye. Only the group with 4% of their diet had an effect on thyroid stimulating hormone, and follow on effects on t3 and t4. This increased stimulation of the thyroid is what they hypothesized is responsible for potential tumor growth. That dose is ~5,000-15,000 times higher than a regular diet. Increasing sugar or alcohol or literally anything else in your diet by that amount will have dire consequences.
Furthermore, the authors mention that a 100x dose human trial had increased TSH, but without changes to t3 or t4. This (and other factors they bring up in the paper) show that humans don’t respond like rats, so these rat studies can’t really be applied to humans. Even a massive overdose wouldn’t have the same potential for causing cancer in human as it does in rats.
All that said, there’s no benefits to the consumer to have food that’s just more red. Banning red 3 isn’t going to make manufacturers stop dyeing food red, it’s going to make them switch dyes, which might not be able net positive.
The FDA’s notice even says this:
two studies that showed cancer in laboratory male rats exposed to high levels of FD&C Red No. 3 due to a rat specific hormonal mechanism. The way that FD&C Red No. 3 causes cancer in male rats does not occur in humans. Relevant exposure levels to FD&C Red No. 3 for humans are typically much lower than those that cause the effects shown in male rats. Studies in other animals and in humans did not show these effects; claims that the use of FD&C Red No. 3 in food and in ingested drugs puts people at risk are not supported by the available scientific information.
They mention that they are forced to ban it due to a technicality of the law:
The Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals.
So even if we know for sure that a substance is fine for humans, if there’s any animal that could be given cancer by ingestion of any dose, it legally should be banned.
For example, if you did a study where you fed dogs chocolate for a year, and they developed liver cancer due to the constant poisoning, you could petition to have chocolate banned as a food edditive.
Who the fuck cares about the article. Where can I buy Starburst fruit by the foot?!?!
Better late than never. Great to see some positive news.
It’ll take at least until 2028 apparently. That’s really late.
It’s kind of understandable though. It would be pretty shitty to tell companies using completely legal means that they have to immediately change their products and methods or shut down.
Any company with competent or moral leadership should have been phasing this out before it was legislated. The information was available for a long time. I don’t think it’s unreasonable to give short timelines. As you said above though, it’s good news so we can focus on that.
Yeah they should be able to wind down the cancer doses in an orderly fashion. We wouldn’t want to hurt their EBITDA
Yea man, lets swing around the power of government wildly to conform with whatever the headlines say today, absolutely and without mercy. I’m sure that will create a functional society. Not like it’s listed openly on the packaging or anything, so people who are extremely concerned have a way to avoid it entirely immediately without waiting for big daddy government to run their lives for them.
headlines
Do you mean the Food and Drug Administration regulator? The one that’s about to be gutted in a week?
What about people getting cancer for a company’s benefit is key to a “functional society” to you?
You really ought to learn to hold more than a single thought in your head at the same time. It’s a very valuable skill which helps navigate this crazy life, like recognizing in this case that there are ordinary people relying upon their jobs to feed their families who would be significantly harmed if the government were to focus exclusively on one thing only when making decisions.
I live in a functional society where ordinary people families don’t have to worry about giving an extra few thousand people cancer to feed their families. Maybe work towards that instead of the new American trend of “we can’t fix that, it’s hard”
What a ridiculous response, the dye’s link to cancer has been known for decades. The EU banned use of it in 1994, over thirty years ago, and its already banned in China and Japan. Trying to paint a government ban of a known carcinogen as “big daddy government running peoples lives” is pure idiocy.
Try actually comprehending what you read. I’m saying it’s understandable that they’re giving companies time to adjust their formulas/processes. I have not once said the ban is a bad idea. Frankly, as my first comment stated quite clearly, I’m very happy this is happening.
Too many people treat anything other than full throated fellating of today’s headlines as though it were some sort of nefarious villainy.
