The colour additive INS 127, commonly used in strawberry-flavoured milkshakes, ice cream, candies, bubble gum, and waffles in India, has been banned in the United States by the Food and Drug Administration (FDA) after studies found it caused cancer in rats.
The additive, also known as Red No. 3 or Erythrosine, is still widely used by both well-known and new food brands across India.
In its order, the FDA said that Red No. 3 can cause cancer in male rats through a hormone-related mechanism. As a result, the agency has revoked its approval for use in food products under US law.
In India, Erythrosine is allowed under the Food Safety and Standards (Food Products Standards and Food Additives) Regulations, 2011, where it is listed as a synthetic food colour. Under the International Numbering System for Food Additives, it is identified as INS 127.
The FDA stated, “We are revoking the authorisation for the use of FD&C Red No. 3 based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act (FD&C Act).” 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.
According to the FDA, “Data presented in a 2022 colour additive petition show that this ingredient causes cancer in male laboratory rats exposed to high levels of FD&C Red No. 3 through a hormonal mechanism specific to male rats.” However, the agency noted that studies in other animals and humans did not show the same effect, and there is no evidence suggesting FD&C Red No. 3 causes cancer in humans.
The FDA emphasised, “Colour additives, including FD&C Red No. 3, require pre-market review and approval. The law requires evidence that a colour additive is safe under its intended conditions of use before it may be added to foods.”
