FDA bans red dye no. 3 in food, beverages and drugs after decades of controversy

USA – The U.S. Food and Drug Administration (FDA) has officially banned the use of red dye No. 3 in food, beverages, and ingested drugs, more than 30 years after scientific studies linked the additive to cancer in animals.  

The decision, announced recently, follows a petition filed in November 2022 by advocacy groups, including the Center for Science in the Public Interest and the Environmental Working Group, urging the FDA to act on long-standing health concerns. 

Manufacturers using red dye No. 3, chemically known as erythrosine, in food and ingested drugs must reformulate their products by January 15, 2027, and January 18, 2028, respectively.  

The ban also applies to imported goods, requiring international compliance with U.S. regulations. 

The move has been hailed as a significant win for public health. Ken Cook, president of the Environmental Working Group, described it as a “monumental victory” for consumer safety.  

He credited public health advocates like Michael Jacobson for decades of persistent efforts to address the risks associated with the dye. 

Red dye No. 3 is a synthetic petroleum-based color additive commonly used to give a bright cherry-red appearance to candies, foods, and beverages.  

Despite being banned for use in cosmetics and topical drugs in 1990 due to findings that it caused cancer in rats, its use in food and ingested drugs remained permissible under the Delaney Clause of the Federal Food, Drug, and Cosmetic Act.  

The clause prohibits the FDA from approving color additives that cause cancer in animals or humans when ingested. 

The FDA explained that the delay in banning red dye No. 3 for food stemmed from differences in how the dye interacts with human biology compared to lab animals.  

The agency stated that “relevant exposure levels for humans are typically much lower” than those tested in rats.  

While no direct links to cancer in humans have been established, the FDA’s decision to revoke the additive’s authorization aligns with legal requirements under the Delaney Clause. 

The FDA’s decision also comes after California enacted a statewide ban on red dye No. 3 in October 2023. 

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