FDA Bans FD&C Red #3 in Foods and Ingested Drugs even though there are no safety concerns indicated for humans!!!
Big announcement from FDA TODAY!! - The authorized use of FD&C Red 3 in food and ingested drugs is being revoked. This action is in response to a petition submitted to FDA based on the Delaney clause. The Delaney Clause applies when data demonstrates a substance can cause cancer in man OR animals. Data on Red 3 shows that it can cause cancer in male rats at extremely high dosages way above any level that humans could experience! While additional information shows this effect doesn't occur in humans, FDA concluded that the Delaney Clause applies since this antiquated law does not allow for any type of scientific risk assessment to be used even when an animal study is shown not to be relevant to humans!
FDA to Revoke Authorization for the Use of Red No. 3 in Food and Ingested Drugs | FDA
This article from FDA's website makes the following key point: "The petition requested the agency review whether the Delaney Clause applied and cited, among other data and information, 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. “
The important issue here is that there is no credible scientific evidence showing that there are any safety concerns with the use of FD&C Red #3 in humans which is what this authorization is for that is being revoked. Unfortunately, the Delaney Clause is an antiquated law that does not allow for any type of risk assessment to determine if there actually is any risk to human safety if ANY animal study shows cancer like with the two Rat studies used to ban Red 3!
The two Rat studies conducted in the 1980s that indicated this problem were poorly designed in that only the highest level of Red 3 that was dosed to the Rats showed any issues and industry had told FDA that the iodine constituent in Red 3 might cause thyroid problems at that high dose level and that this study should not have been run since it was not relevant to any realistic exposure level of Red 3 that humans would ever experience. The high level of dye that was used actually turned the skin of the Rats bright red which is ridiculous! Unfortunately, FDA requested that the studies be done at that high level anyway and of course, there were some thyroid problems from the iodine constituent as expected. This however then caused a Delaney problem since Delaney doesn't allow for any type of scientific risk assessment of the data once cancer is indicated in ANY animal study.
Unfortunately, FDA has decided to bow to the political pressure of the consumer groups here rather than try to get the Delaney Clause updated to current thinking which would allow for a scientific risk assessment approach. Had FDA done this, I strongly doubt that Red 3 would have been banned. It is high time for FDA to pressure Congress to change the Delaney Clause to use good science.
I am very happy to see that the International Association of Color Manufacturers has responded today to this unfortunate FDA Ban based on nothing more than the Delaney Clause. You can see their response with the facts concerning the safety of FD&C Red #3 at the following link:
Here is additional information from FDA concerning the revocation of the authorization of Red #3 and the safety of Red #3 including the prepublication draft of the Federal Register listing which will be published on January 16, 2025:
2025-00830.pdf (Federal Register prepublication draft)
The prepublication draft of the Federal Register notice provides significant information concerning the history of the regulatory actions related to Red 3 and discusses the limitations in FDA’s authority to use good scientific risk assessment in making decisions regarding color additive safety under the outdated Delaney Clause. This Federal Register notice also provides information on all the comments submitted to the consumer group’s color additive petition along with FDA’s response. You will see that FDA seems to agree that there is no real safety concern for humans regarding the use of Red 3 but that they are very limited in what they can do under Delaney. I recommend that you read this notice in detail if you would like all the background on this situation. I hope a number of parties decide to object to this outcome! The Federal Register notice provide instructions for how you can object and possibly seek a stay of this regulation. IT’S TIME THAT WE STAND UP AND FIGHT THE DELANEY CLAUSE WHICH MAKES NO SENSE TODAY!!
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UPDATE - January 16, 2025
Here is a link to the official Federal Register Notice that came out today regarding FDA’s revocation of the authorization for FD&C Red #3:
This document provides a lot of good background information about the real situation with FD&C Red #3 and the problems with the outdated Delaney Clause. It also addresses the comments that were submitted concerning the petition from the consumer groups. For example, here is a key response to Comment #2 that is important to consider:
“Consistent with our conclusion in revoking certain food additive approvals based on the Delaney Clause (83 FR 50490), FDA concludes that the Delaney Clause limits FDA's discretion to determine the safety of color additives that are intended to be ingested (such as the use of FD&C Red No. 3 in food and ingested drugs) in that it prevents FDA from finding such a color additive to be safe if it has been found to induce cancer when ingested by humans or animals, regardless of the probability, or risk, of cancer associated with exposure to the additive or of the extent to which the experimental conditions of the animal study or the carcinogenic mode of action provide insight into the health effects of human consumption and use of the additive in question.”
Here is another response to Comment #3 that shows that FDA feels that they have no ability to use risk assessment to justify the use of a color additive if any tumors are shown in any animal study under the Delaney Clause:
“Again, we acknowledge the large body of published literature that does not show FD&C Red No. 3 inducing cancer in female rats, or multiple other animal species, including humans (Refs. 5 and 6). However, under the Delaney Clause, these negative findings do not outweigh or negate the positive findings of the two chronic feeding studies. Because FD&C Red No. 3 has been found to induce tumors in male rats, FDA must revoke the regulations providing for these uses of the color additive as a matter of law.”
The FDA response to Comment #6 is very telling. Clearly, FDA sees no risk to humans from FD&C Red #3 and agrees with JECFA and other global regulators that FD$C Red #3 meets the safety standard to be an acceptable food color. However, the Delaney Clause does not give them the discretion to make this type of decision since there are the two rat studies that showed a thyroid problem and this is not disputed, even though these studies are not relevant to humans! Here’s the FDA response to Comment #6:
“Based on our evaluation of the dietary exposure to FD&C Red No. 3 and the available scientific evidence, we conclude that FD&C Red No. 3 meets the safety standard of a reasonable certainty of no harm required for a color additive (see Refs. 6 and 7). We derived a 210-fold margin of exposure between the highest dietary exposure to FD&C Red No. 3 (0.25 mg/kg bw/d) and the No Observed Adverse Effect Level chosen by the CAC (35.8 mg/kg bw/d) (Ref. 6). We agree that the highest dietary exposure to FD&C Red No. 3 is below the ADI established by JECFA in 2018 (6 mg/kg bw/d). We also agree with JECFA's conclusion that the possibility of developing thyroid tumors in humans at low dietary exposure levels from the current uses of FD&C Red No. 3 is unlikely (Ref. 6). However, as a matter of law (see section 721(b)(5)(B) of the FD&C Act), we must revoke the regulations authorizing the uses of FD&C Red No. 3 because it has been shown to induce cancer in male rats.”
In their response to Comment #7, they state the problem with the Delaney Clause very specifically:
“The Delaney Clause prevents us from finding its use to be safe, regardless of the extent to which the experimental conditions of the animal study provide insight into the health effects of human consumption and use of the color additive in question.”
As you can see, it is clear that FDA would probably never have banned the use of FD&C Red #3 if they were able to actually use scientific discretion and risk assessment to come to a conclusion since there is no scientific evidence showing any safety concern for humans from the use of this dye. However, here we are with a ban, given that the Delaney Clause ties FDA’s hands to make any type of scientifically based decision about FD&C Red #3 (or any other color additive for that matter that might have this issue in the future)!
Groups and Companies that may be impacted by this determination can file objections to this outcome, and I hope that a number of them will. I think it is time that the industry begin to challenge the outdated Delaney Clause and try to get this changed in Congress since this could be used against other important food/color additives and excipients in the future. Objections however must be made by February 18, 2025, to be considered by FDA.
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UPDATE - January 21, 2025
Check out this link for a great article which provides the facts related to Red #3 rather than the spin the crazy NGOs and the media have been putting on this. There are no human safety concerns with this color as FDA strongly stated and this article explains why the Delaney Clause needs to be revoked! It is no longer in sync with modern risk assessment science!
Red #3's Swan Song: The Science Behind the FDA's Latest Decision
Additionally, I wanted to mention that the studies that are discussed in the article that alluded to hyperactivity or ADHD issues in children for the other synthetic colors like Red #40 and Yellow #5 have also been shown to have no scientific credibility and all the worry about these colors is also off- base!! There is no credible safety concerns demonstrated for these colors as well and this is why FDA is not taking any actions against them. There is simply no justification to do so!