USA | The FDA has revoked the authorisation for using FD&C Red No. 3 as a matter of law, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
The FDA has amended its colour additive regulations to no longer allow for the use of FD&C Red No. 3 in food and ingested drugs in response to a 2022 colour additive petition.
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 caused 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 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 Delaney Clause, enacted in 1960 as part of the Colour Additives Amendment to the FD&C Act, prohibits FDA authorisation of a food additive or colour additive if it has been found to induce cancer in humans or animals.
This was not the first time the agency revoked an authorisation based on the Delaney Clause. For example, in 2018, the FDA revoked the authorisation for certain synthetic flavours based on the Delaney Clause in response to a food additive petition.
FD&C Red No. 3 is a synthetic food dye that gives foods and drinks a bright cherry-red colour. The FDA estimated that FD&C Red No. 3 is not as widely used in food and drugs as other certified colours based on information available in third-party food product labeling databases, food manufacturers’ websites, other public information, and the FDA’s certification data.
FD&C Red No. 3 has been primarily used in certain food products, such as candy, cakes and cupcakes, cookies, frozen desserts, frostings and icings, and certain ingested drugs.
Manufacturers who use the colour in food and ingested drugs will have until the 15th of January, 2027 or 18th of January, 2028, respectively, to reformulate their products.
Other countries still currently allow for specific uses (called erythrosine in other countries). However, foods imported to the U.S. must comply with U.S. requirements.
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