On January 15, the FDA announced it is revoking the approval for FD&C Red No. 3 in food and ingested drugs, based on the Delaney Clause of the Federal Food, Drug, and Cosmetic Act. This decision follows a 2022 petition requesting the agency reconsider the dye’s use. The petition cited studies that showed cancer in male rats exposed to high levels of FD&C Red No. 3, but this risk is specific to rats and does not apply to humans.
Karen Blakeslee, Kansas State University Extension Associate, provided insight into the ban and its implications.
Blakeslee clarified that the ban specifically targets FD&C Red No. 3, not other red food dyes. The petition highlighted studies showing cancer in rats. However, she emphasized that the cancer risk did not translate to humans or other animals. According to Blakeslee, the available scientific evidence does not support claims that FD&C Red No. 3 poses a human health risk.
Blakeslee mentioned promising natural alternatives to synthetic red dyes, “Some possible natural alternatives include Beet Root Powder, Carmine, or natural color pigments from produce such as blackberries, red cabbage, and grapes. Some challenges will be to find the right color to meet the same bright red color consumers are used to seeing and be stable during temperature changes or when mixing with other ingredients,” she said.
The approval of food additives involves numerous challenges, Blakeslee explained. These include understanding how the additive interacts with food, regulatory issues, and consumer acceptance. Additives undergo rigorous safety assessments, considering factors such as the likelihood of consumption, cumulative effects, and scientific evidence that confirms no harm will result from their use.
Food manufacturers have until January 15, 2027, or January 18, 2028, depending on the size of the business, to comply with the ban. Blakeslee also pointed out that imported foods must meet the new requirements as well.
As the FDA works to implement these changes, Blakeslee advised consumers to be aware of the evolving regulations and to consider the potential benefits of transitioning to safer, natural food colorants.
