The FDA plans to eliminate six widely used synthetic food dyes—including FD&C Red No. 40 and Yellow No. 5—by the end of 2026.
The HHS and the FDA announced a phased withdrawal of all petroleum-based synthetic dyes from the U.S. food supply as part of the Make America Healthy Again initiative. Since citing growing concerns about the health effects of synthetic dyes, particularly in pediatric populations, the agency will implement a national standard and timeline for transitioning to natural alternatives.
The FDA will begin the process of revoking the authorization of Citrus Red No. 2 and Orange B and is coordinating with industry to eliminate six additional dyes—FD&C Green No. 3, FD&C Red No. 40, FD&C Yellow No. 5, FD&C Yellow No. 6, FD&C Blue No. 1, and FD&C Blue No. 2—by the end of 2026. The agency also plans to authorize four new natural color additives in the coming weeks and has expedited reviews of other candidates, including calcium phosphate, Galdieria extract blue, gardenia blue, and butterfly pea flower extract.
In collaboration with the NIH, the FDA will enhance research on the health and developmental effects of food additives in children. The agency has requested that food manufacturers accelerate the removal of FD&C Red No. 3 ahead of the previously scheduled 2027 to 2028 timeline.
According to HHS Secretary Robert F. Kennedy, Jr., the initiative aims to reestablish rigorous scientific standards, promote practical regulatory approaches, and strengthen public confidence in food safety policy. FDA Commissioner Marty Makary, MD, MPH, noted that, considering rising rates of childhood obesity, diabetes, attention-deficit/hyperactivity disorder, and depression, minimizing potential exposure to synthetic additives is a prudent public health measure.
To facilitate industry compliance, the FDA will provide regulatory guidance and flexibility throughout the transition. These actions follow the FDA’s request for food companies to use natural ingredients in the U.S. as they already do in Europe and Canada and reflect the agency’s role in ensuring the safety of the nation’s food supply.
Source: FDA