FDA Issues Ban Of Red Dye No. 3 In Foods

The Food and Drug Administration (FDA) has issued a ban on red dye No. 3, a popular food additive used in food, drinks, and some drugs. The FDA established decades ago that red dye No. 3 had links to certain types of cancer and will no longer be used in the United States.

The FDA issued a constituent update this past Wednesday (Jan. 15) stating the agency’s decision to ban the use of the food additive, citing the “Delaney Clause” from the Federal Food, Drug, and Cosmetic Act (FD&C Act).

From the FDA:

The FDA is revoking the authorization for the use of 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 is amending its color 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 color 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 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 Delaney Clause, enacted in 1960 as part of the Color Additives Amendment to the FD&C Act, prohibits FDA authorization of a food additive or color additive if it has been found to induce cancer in humans or animals. This is not the first time the agency revoked an authorization based on the Delaney Clause. For example, in 2018, the FDA revoked the authorization for certain synthetic flavors based on the Delaney Clause in response to a food additive petition.

Red dye No. 3 is a synthetic food dye derived from petroleum and erythrosine is its true chemical name. The dye isn’t used as widely as other dyes but appears in candies, cakes, cookies, frozen desserts, and ingested drugs. Food manufacturers will have until January 15, 2027, to eliminate the dye from their products. Comparatively, drug companies have until January 18, 2028, to do the same.

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