The U.S. Food and Drug Administration’s (FDA) recent announcement that the red dye known as erythrosine, FD&C Red No. 3 or Red 3 – previously authorized for use as a colour additive in food and ingested drugs – will be banned in the U.S. will go down in history as the very definition of a red herring.
While Health Canada says the dye does not pose a health risk to the general population in Canada, the ban means food manufacturers in the U.S. have until January 2027 to remove the dye from their products. Drug manufacturers have until January 2028 to remove the dye from ingested drugs.
Red 3 has been around for a long time:
- In 1907, the FDA approved Red 3.
- In the 1980s, studies found that Red 3 caused thyroid cancer in rats exposed to high doses over long periods.
- In 1990, the FDA banned Red 3 from cosmetics based on the Delaney Clause, which requires the FDA to ban food additives found to cause or induce cancer in humans or animals.
- In 2022, the Centre for Science in the Public Interest (CSPI) and other organizations petitioned the FDA to ban Red 3 from food.
When the FDA was asked to evaluate the safety of Red 3, chronic feeding studies conducted prior to 1976 revealed no evidence of neoplastic responses. Unsatisfied with this data, FDA subsequently conducted additional longer-term studies – the first of which was a chronic feeding study where mice were randomly assigned to one of five treatment groups (120 mice per group) that received Red 3 in dietary concentrations of 0 per cent, 0 per cent, 0.3 per cent, 1.0 per cent and 3.0 per cent for 24 months. This study also found no adverse effects.
Realizing that Red 3 is tolerated well at those doses, the FDA undertook further studies in which it looked at the safety of Red 3 at much higher doses. In a chronic feeding study, 70 male rats were given large oral doses of Red No. 3 equalling 4 per cent of their diets; 15 out of the 69 male rats developed thyroid follicular cell adenoma while only one out of 69 did in the control group. Interestingly, even at these high doses, no statistical significance was found in the female rats in the study.
No subsequent data showed any correlation or relationships between Red 3 and cancer – or any kind of cancer for that matter.
In an inexplicable move, given most of the studies showed no increased cancer risk and the increased risk was only seen when extremely large quantities were consumed, the FDA banned Red 3 in cosmetics. Despite periodic multiple re-assessments of Red Dye 3, the FDA chose not to ban this dye in food products.
Why? Because every re-evaluation – including assessing how much an average person would consume in a day even at the highest quintile – came to the same conclusion: that Red 3 was safe to be ingested at the amounts individuals are expected to consume. In fact, immunologist Dr. Andrea Love calculated that an average person’s daily consumption of Red 3 is 7,500 times less than what the rats in the aforementioned study ingested.
In short, the dose makes the poison.
In short, the dose makes the poison. You could eat Costco-sized packages of Skittles, Peeps and Fruit Loops in a single day and still not meet the toxicity threshold. You would have to do it again, day after day, for an extended period to have any effect on your liver. So, let’s be clear – you likely will have far bigger health issues than liver carcinoma before then.
While Europe banned Red 3 in 1994 using the same lackluster data, most other countries continue to use it, albeit often under different names. The FDA says its recent ban is a “matter of law,” citing the Delaney Clause, and follows a renewed petition in 2022. However, Jim Jones, the Deputy Commissioner for Human Foods at the FDA, stated that “the way Red No. 3 causes cancer in male rats does not occur in humans with relevant exposure levels to FD&C Red No. 3 being typically much lower in humans than those that cause the effects shown in the rats.”
In discussing Red 3, what comes up often is its effect on children’s behaviour. Looking at the totality of evidence, it does appear that Red Dye 3 does not cause noticeable neurobehavioural adverse effects; however, in teasing the data, it does seem that a subset of children could be more sensitive to this dye. Indeed, a few studies show that ingesting Red Dye 3 in some children may increase inattentiveness, hyperactivity and restlessness, both in children with and without preexisting behavioural disorders. But to what degree, which children and why, at what dosage, and so forth are yet to be understood and, with that, the relationship between cause and effect.
So, the question bears repeating: Is this truly a battle worth fighting?
Whether this ban is simply low-hanging fruit or virtue signalling, the dye can be replaced with non-synthetic colourings like paprika or beetroot. But at what cost to resources? Wasteful depletion of time, energy and resources on issues that ultimately will have little to no impact on our overall health and well-being hardly seems efficient. Resources are finite; we should be mindful of how we use them.
My recommendation? Focus on dietary things that truly matter: Limit processed food and added sugars, eat a balanced, wholesome plant-forward diet with fruits and vegetables, exercise and, of course, minimize consumption of things we know without a doubt are carcinogenic even at lower amounts, such as alcohol.
