Tom Neltner, J.D., is Chemicals Policy Director.
The Center for Science in the Public Interest’s (CSPI) “Seeing Red: Time for Action on Food Dyes” report, released yesterday, makes clear that certified colors added in food are not safe at the current levels that children consume them. The Food and Drug Administration (FDA), the food industry, and consumers should take action to protect children from the behavior problems associated with these chemicals.
What are color additives?
- The FD&C number on a color means it is a “certified” color pursuant to 21 CFR Part 74. These colors are synthetically made from oil or coal. Decades ago, FDA determined they were safe and only certifies that each batch meets quality standards and does do not contain particularly dangerous contaminants.
- A color additive is not safe unless there is “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use.”
- FDA labeling rules maintain that all added colors to food are artificial. Technically, there are no natural colors – not even beet juice – since they mask the natural color of the food.
- FDA does not limit the amount of a certified color that can be added to food except in one case. The food manufacturer decides how much is needed.
So what prompted FDA’s tweets? Most likely the agency anticipated CSPI’s report “Seeing Red: Time for Action on Food Dyes” issued January 19. It follows on the organization’s 2010 “Food Dyes: Rainbow of Risks” report and its 2008 citizens petition calling on the agency to: 1) revoke its approvals of eight synthetic food dyes; 2) require warning labels on the package in the interim; and 3) correct statements about the dyes on its website and other materials.
While FDA has yet to take action on the citizens petition, the marketplace has already passed judgment. In 2015, leading food manufacturer and restaurants committed to reformulating their iconic brands to remove certified artificial colors. They follow the lead of major retailers who reformulated their private brands to remove the chemicals.
According to FDA’s regulations, a color additive is not safe unless there is “convincing evidence that establishes with reasonable certainty that no harm will result from the intended use.” In addition, the law requires the agency to consider “the cumulative effect, if any, of such additive in the diet of man or animals, taking into account the same or any chemically or pharmacologically related substance or substances in such diet” in determining safety.
The standard is the most protective of any chemical use. It is similar to the one for food additives except that the evidence of safety must also be “convincing.”
CSPI’s report makes a compelling case that FDA effectively stacked the deck when it sought advice from the agency’s Food Advisory Committee in 2011 in response to CSPI’s citizens petition. The agency asked whether or not a causal relationship between consumption of certified color additives in food and hyperactivity in children in the general population had been established. Causality a much higher scientific burden of proof than the actual safety standard required by the law.
Not surprisingly, the advisory committee did not find causal evidence and as such did not recommend FDA act to restrict use. If the committee had instead been given the actual safety standard for color additives and asked whether there was convincing evidence the chemicals were safe, CSPI maintains the committee would have recommended that FDA remove the colors from foods, or at a minimum, require a warning label similar to the one used in Europe.
CSPI’s report also cites post-2011 scientific evidence that strengthens the association between ADHD and certified color additives and demonstrates that food marketed to children contains higher levels of colors than previously assumed.
Will FDA follow the lead of the marketplace and act to protect children from the risk associated with the use of these chemicals? A proper interpretation of the law demands it.