Protecting families from contaminated food and water
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Protecting families from contaminated food and water
Posted in Our Blog on January 19, 2025
Red Dye No. 3 officially gets the ole’ heave ho on January 15, 2025, banning the additive in foods made or sold in the United States.
But what exactly does that mean?
How soon does enforcement go into place?
And what does this mean for other red dyes?
Follow along as we dive into the new food red dye no. 3 ban and how this move may impact the color of your food in the future.
Adding Red Dye No. 3 to the Federal Register makes this move official. This amends the FDA’s color additive regulations to “no longer allow for the use of FD&C Red No. 3 in food and ingested drugs.”
This register serves as an official public record for the federal government. A national “newspaper” accessible to all and archived for record and posterity.
Most people know that many artificial colors and additives aren’t so great for us.
But are they bad?
Enough people thought so.
A 2022 petition asked the FDA to look into Red Dye No. 3 to determine if it stood up to the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. A clause enacted in 1960 banning food additives (among other things) which are found to cause or induce cancer in humans or animals based on scientific studies.
It got enough attention, so the FDA made a request for scientific evidence of the safety of this additive in order to maintain its use.
For initial use, color additives must undergo a pre-market review and approval process. The governing body for this process is the FDA. A manufacturer petitions the FDA to approve their color additive. Such factors as likely amount of consumption, intended use, physical and chemical properties, and the manufacturing process are evaluated.
The opposite holds true. Certain advocacy groups can also petition for a review. If enough of a cause for review is provided, like the case for Red Dye No. 3, the FDA can request additional scientific data.
This data was not favorable.
Two studies are cited in this ban. Both involved measuring the impact of high levels of Red Dye No. 3 in rats.
Both studies showed the dye did cause cancer in male rats.
However, those objecting to the results claim that a specific hormone mechanism found in rats does not exist in humans, and therefore the study does not indicate any true risk to human health.
Additionally, the dose of Red Dye No. 3 in the rat study is much higher that what would be consumed by a human, making the case even stronger for small dosages being safe for humans.
But the FDA didn’t buy it.
More studies must be performed to render judgement in the opposite direction. Enough data was provided to move forward to the ban.
While the announcement was made on January 15, 2025, we likely won’t see changes right away. According to the notice, manufacturers using the now-banned dye in food will have until January 15, 2027 to comply.
While other countries currently allow use of the dye, sometimes called erythrosine, products imported into the U.S. must comply with this U.S. requirement.
While sometimes used in medications, this synthetic food dye is primarily used in foods and beverages to impart a bright, cherry-red color. This dye can be found in candy, cakes, cupcakes, cookies, frozen desserts, as well as frostings and icings.
While not a comprehensive list, the following candies and drinks contain the now-banned dye:
Expect changes soon.
Prior use additives were given the initial green light under the Food, Drug, & Cosmetics Act. Since it was already in use in 1969, it was allowed. At least provisionally.
In 1990, however, a petition to permanently authorize use of the dye as a color additive was made. To do so, the petitioner needed to provide scientific evidence supporting the safe use of the color additive. This is where the rat study came into play.
The FDA denied the petition for permanent authorization citing that Delaney Clause.
Even back then.
A few years later, in 1992, the FDA showed interest in revoking foods and drugs using the defamed dye. However, not enough data was made available to raise safety concerns in humans.
So, it was allowed to stay. Albeit monitored.
But now, in the age where people are paying more attention to what’s in their food and concern over data suggesting the harmful effects these dyes and additives play in children’s development, reproductive health, and other aspects of the human condition, the petition re-emerged.
Red Dye No. 3 is not the only red dye used. While this one has recently made the news, Red Dye No. 40 is probably the one most people are familiar with.
So, what is the difference between them?
No. 3 (known as erythrosine) and No. 40 (known as Allura Red) are both synthetic color additives made from petroleum.
While similar, they are produced in different ways.
Red Dye No. 40 is commonly found in certain snack foods and beverages like candy, chips, and sport drinks. While No. 3 produces a bright red color, No. 40 makes a darker red impression.
While the still-approved Red Dye No. 40 has not been proved to cause cancer, those with allergies or sensitivities to food dyes often have problems with its consumption.
Does the presence or absence of synthetic dyes like the now-banned Red Dye No. 3 or still-approved Red Dye No. 40 impact what goes into your shopping carts and ultimately in your family’s belly’s?
Did any of the products containing Red Dye No. 3 surprise you?
Follow MakeFoodSafe.com to learn more about this and other safety topics.
If you’d like to know more about food safety topics in the news, like “Red Dye No. 3 Gets Axed. But What About the Other Reds?,” check out the Make Food Safe Blog. We regularly update trending topics, foodborne infections in the news, recalls, and more! Stay tuned for quality information to help keep your family safe, while The Lange Law Firm, PLLC strives to Make Food Safe!
By: Heather Van Tassell (contributing writer, non-lawyer)