FDA revokes authorization for use of red dye erythrosine in food and drugs
The US Food and Drug Administration (FDA) has officially revoked the authorization for erythrosine, a synthetic food dye also known as FD&C Red No. 3, in food and ingested drugs.
Erythrosine is commonly used to give a bright red color to various products, including candies, cakes, and some medications. The FDA has noted that its usage is less widespread compared to other color additives, according to data from food manufacturers and product labeling. The FDA had previously ruled in 1990 that erythrosine should not be used in cosmetics due to its association with thyroid cancer in male rats. Despite this earlier decision, the dye has remained in use within the food industry, raising concerns among health advocates.
The recent decision, rooted in the Delaney Clause of the Federal Food, Drug, and Cosmetic Act, follows a 2022 petition from the Center for Science in the Public Interest (CSPI) and other advocacy groups that questioned the dye's safety. Enacted in 1960, the Delaney Clause prohibits the approval of any food additive found to induce cancer in humans or animals. This isn't the first instance of the FDA revoking an authorization under this clause; in 2018, it took similar action concerning certain synthetic flavors.
The petition was requested based on studies indicating that high levels of erythrosine caused cancer in male rats. However, the FDA emphasized that the cancer risk mechanism observed in these studies does not translate to humans, as the exposure levels for people are significantly lower than those that triggered cancer in laboratory conditions. Additionally, research conducted in other animal species and humans has not shown similar cancer risks.
However, beyond potential carcinogenic effects, there are increasing concerns regarding the impact of synthetic food dyes on children's behavior, particularly in relation to Attention Deficit/Hyperactivity Disorder (ADHD). Studies suggest that these dyes may negatively affect behavior, although individual sensitivity can vary widely.
Manufacturers have until January 15, 2027, to reformulate food products containing the dye, and until January 18, 2028, for ingested drugs. While some countries still permit limited use of erythrosine (such as the European Union, where it is exclusively authorised for use in cocktail and candied cherries, and Bigarreaux cherries), foods imported into the US must adhere to American regulations.
The CSPI has welcomed the FDA's decision as a positive step toward ensuring food safety and called for further actions against other harmful chemicals in food products. They emphasize that food dyes offer no nutritional benefits and are primarily used for aesthetic purposes. As the FDA moves forward with this ban, the focus now shifts to ensuring that consumers are protected from potentially harmful substances in their food and drugs.
Source: