CSPI Asks FDA to Ban Certified Colors

The Center for Science in the Public Interest (CSPI), Washington, D.C., petitioned FDA to ban FD&C Yellow 5 and the other certified food dyes, and in the interim require a warning on foods containing the colors. The petition cites research that indicates these, as well as other synthetic colorants not approved for U.S. use, are linked to hyperactivity and behavior problems in children.

The CSPI petition states: “The burden of proof should shift to industry to prove that dyes, individually or in combination with one another, do not affect children’s behavior—but responsible companies could voluntarily and immediately switch to safer natural colorings or simply use nutritious ingredients, such as fruit or fruit juice, that the dyes are used to simulate.”

Concurrently, 19 psychiatrists, toxicologists and pediatricians cosigned a letter sent to Congress, endorsing CSPI’s petition and asking Congress to:

• Investigate what the government has done to inform the public and “protect children from unnecessary exposure” to ingredients that trigger behavior problems;
• Introduce legislation “to end the use of food dyes and other unnecessary food ingredients that adversely affect children’s behavior”;
• Direct FDA to revise or withdraw “its inaccurate brochure” on the subject;
• Fund the Institute of Medicine to review the research on food ingredients and behavioral problems, and recommend additional research and “child-protective public policies.”

The FD&C colors named in the petition include Yellow 5 and 6, Red 40 and 3, Blue 1 and 2, Green 3 and Orange B. CSPI notes the rise in the use of these colors in the United States: “According to the FDA, the amount of food dye certified for use was 12 milligrams per capita per day in 1955. In 2007, 59 mg per capita per day, or nearly five times as much, was certified for use.”

FDA and other governmental agencies have affirmed the safety of these colorants, especially since questions arose in the ’70s due to the popularity of the additive-free “Feingold diet.” However, recent studies at England’s University of Southampton that found a statistically significant link between child hyperactivity and the consumption of mixtures of sodium benzoate with several artificial colors—including a few not used in the United States—have raised new questions.

A statement released by Robert Brackett, chief science officer for the Grocery Manufacturers Association (GMA), Washington, D.C., said, in part: “To date, the overwhelming majority of scientific evidence confirms the safety of certified food dyes and their lack of effect on behavior in children. As for the study cited in the petition filed by the Center for Science in Public Interest, EFSA reviewed the findings, noted considerable uncertainties, absence of clinical significance of behavior changes, and lack of discrete evaluation of individual colors or additives. EFSA concluded that the study did not support a change in current policy on the studied food colors and additives.”

FDA defines the certified colors in Title 21 of the Code of Federal Regulations, Part 74. However, the agency does not recognize a category of “natural colors,” but colorants commonly known by this name can be found in 21 CFR Pt. 73, “Color Additives Exempt From Certification.”