In an announcement issued on 4/22/2025, the FDA has announced a few different items. First, some synthetic dyes will be phased out: Citrus Red No. 2 and Orange B (initiation of process to revoke authorization), FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2 (goal is to phase out by the end of 2026), and FD&C Red No. 3 (already slated to be removed but with an accelerated timeline). Additionally, the FDA wants to begin the process to accelerate the approval of some natural alternatives. Given the relatively spotty record of the FDA as of recently, I should indicate that these terms are being used by the FDA. So, let’s examine what that means here.

The Orange B dye is a dye that is currently authorized for restricted use. However, I should note the revocation of status is mostly political theater. For starters, even though the dye is authorized (on a restricted basis), it is not used in food. To understand this, the use case is solely for hotdog and sausage casings. Additionally, Orange B (aka C.I. Acid Orange 137) is not currently made in the United States as the producer, William J. Strange Company, does not currently exist.

Then there is Citrus Red No. 2., a dye that is solely authorized to be used to color the peels of oranges. Additionally, the dye is only used on oranges that have been slated for consumption, not those used for processing. And, for any concerns about safety, it cannot pass through the orange peel. If you’re wondering why is the die even used then, here’s a fun fact about oranges: depending on the temperature, oranges can be green when ripened. In order to make them look more appealing to consumers, a traditionally orange color is added to the fruit. So, again, this dye is not meant to be consumed. A fair comparison would be if you were to eat the wrapper around a candy bar, then complain about the issues associated with eating said candy bar. In other words, while there are steps that could be taken to mitigate any theoretical issues that there might be, the issue is so small such that this is not a real issue that needs to have resources wasted on it.

Next, we have FD&C Green No. 3. This green dye is not allowed for food use in the EU. It is also not absorbed well by human intestines. Now that we have the scary part out of the way, let’s talk about the more grounded portions. Even though use is restricted in the EU, the dye, also known as Fast Green FCF, has been found by WHO to have low toxicity and to not be carcinogenic and not genotoxic. The report was released in 2017, so this is not news. On top of this, Fast Green FCF is the least used food dye out of the main dyes approved by the FDA. So, this is also a non-issue.

Then, there is FD&C Red No. 40, also known as Allura Red AC. This dye is an azo dye; in terms of uses, it has been used as a color additive in foods that are “cherry” flavored. It is also used for some tattoo inks. Originally, the dye was created and marketed as a replacement for amaranth in the United States; it is also the most used red dye in the United States.

That being said, there is some controversy around the dye in terms of safety. It has been evaluated by the Joint FAO/WHO Expert Committee on Food Additives in the following years: 1974, 1980, 1981, and 2001. There are some indications that chronic exposure leads to increased incidence of bowel disorders in mice, but more recent studies and papers indicate that whatever other issues there are with the dye are minimal, including minimal kidney harm, minimal effects on weight, and minimal effect on social behavior. Recent studies have also indicated that most of the dye is excreted from the mice. Lastly, some of the studies that indicated significant levels of genotoxicity and potential increase of bowel disorders were not compliant with good laboratory practices. In short, the controversy around the dye is probably overblown, not requiring this type of response. Aside from not introducing much of a change to the health of the citizenry, the shift will almost certainly have economic consequences.

FD&C Yellow No. 5, also known as Yellow 5, E102, or tartrazine, the dye is yellow in color and often used to add a “lemon” yellow color to desserts/pastries, soft drinks, sports drinks, chips, mustard, and more. There are “concerns” that the dye exasperates asthma and trigger food-intolerance in some children. However, there is next to no credible medical or scientific evidence to support these claims. Any correlation between the presence of tartrazine and these issues is weak at best. There is a real issue: it has been known to trigger hives in approximately 0.01% to 0.1% of the population. As a result, it is required that use of tartrazine is labeled on food products. While it is an issue, it is not a strong enough issue to be the sole reason that a dye is removed from foods. To quote my great grandmother, it feels like we’re borrowing trouble.

The other yellow dye is FD&C Yellow No. 6, also known as Sunset Yellow FCF or E110. Current (US) guidelines indicate that E110 is safe so long as it is consumed at or below a daily intake of 3.75mg/kg. On top of this, the other concern that it could increase instances of ADHD in children, is unlikely. For starters, the work of the chief proponent of this theory, Benjamin Feingold, has been discredited. Though early studies indicated that there could be a link, the scope of those studies were so limited that meaningful conclusions could not reasonably be drawn.

FD&C Blue No. 1, aka Brilliant Blue FCF, has been found to have low acute toxicity, meaning that it is unlikely to be toxic. Studies performed on dogs and mice have indicated minimal effects from Brilliant Blue FCF. In other words, Brilliant Blue FCF is safe.

FD&C Blue No. 2, aka Indigo Carmine or Indigotine, As indicated by the same body that evaluated Allura Red AC, Indigo Carmine does not present any health concerns so long as it is consumed within known guidelines. Again, this is a food coloring. In other words, you would have to consume an ungodly amount of this stuff in order to see any real issues (based off of current guidelines).

A running thread through all of these decisions appear to be copying the decisions made by regulatory bodies in the EU. That is not to say that these decisions were incorrect in the EU. The fact of the matter is that member countries of the EU, and many other countries, follow a precautionary principle, where restrictions are placed on the inclusion of different products/additives while research is being carried out. All of this is to say that the decisions made by the FDA so long after the fact come off as either

• Pointless posturing or
• Attempts to appear “healthy” by adhering to vague guidelines of wellness that have a minimal scientific basis.

Then there is FD&C Red No. 3: erythrosine. A chemical that was already slated to be removed. Large amounts of the chemical could have a carcinogenic effect. However, it was already slated to be removed. This is definitely political theater. Now, let’s examine the organic alternatives.

The four dyes that have been proposed for a fast tracked review are as follows: calcium phosphate, Galdieria extract blue, Gardenia Blue, and Butterfly Pea Flower extract. Based off of the wording of the announcement, there is a high likelihood of other dyes being considered, but these were the only ones mentioned by name. I’ll do a quick review of these four.

• Calcium Phosphate: a chemical found in bones and teeth enamel. Typically not used as a food additive on its own but has been used as part of a color enhancement system, typically for improving the color of different milk products due to the compounds white color. Currently used as an additive in cosmetics and medicines, excessive consumption has been known to lead to hypercalcemia, kidney stones, and cardiovascular disease, especially in those suffering from chronic kidney disease.
• Galdieria extract blue: a pigment produced by Galdieria sulphuraria, a species of red algae. At present, it appears to have low acute toxicity and is acid stable, which is useful for maintaining the blue color. There have been a few 90 day tests done on rats to determine the safety of the extract; however, it should also be noted that these do not appear to have been long term tests.
• Gardenia Blue: a blue die derived from Gardenia jasminoides, coming from the chemical reaction between the compound genipin and certain amino acids like glycine. While there are concerns about how genipin is cytotoxic when consumed in large amounts, it should be noted that such effects do appear to be present in Gardenia Blue. Long term studies have been performed on rats and indicate that there is no harmful effect on the rats. Strictly speaking, it is already used as a food dye.
• Butterfly Pea Flower extract: a heat stable dye coming from a plant of the same name. It is already used as a food colorant.

So, just so we’re clear, I do not have an issue with the majority of these additives in and of themselves; insofar as safety is concerned, I would like more long term studies done on Galdieria extract blue and strict guidelines and or regulations on the use of calcium phosphate as food coloring. My main point is that this mostly seems like pointless posturing. The dyes are natural, but that does not make them inherently better just because of that fact. If you’re going to overhaul whole sectors of production in the country, then stronger reasons are needed than just a nebulous ideal. Adding them is fine for the most part, but I don’t think the argument is strong enough to conclude that replacement is required.

One thing I should mention is that Galdieria extract blue is manufactured by the company Fermentalg. According to an announcement from the company, it is in the final stages of approval for its extract. The only reason I mention this is that companies are already moving fast to attempt to profit off of this announcement despite the lack of concrete information about what this plan looks like.

Honestly, the move itself is hardly surprising. Not for financial reasons necessarily; at least, not directly. There do not appear to be any obvious direct ties between interested parties and Marty Makary and RFK Jr., who joined the announcement. No, the move is not surprising because this has been a stated interest of RFK Jr. for years at this point.