Did the FDA Get it Right?
After the Southampton studies were released, there were some dramatic changes to the governance of food dyes in Europe. The government of the UK requested that food manufacturers remove synthetic dyes from food in favor of natural ones, and the EU asked manufacturers to either remove the dyes from foods or include a warning label stating that AFCs “may have an adverse effect on activity and attention in children.”
In the US, the Center for Science in the Public Interest led a charge to have the FDA look at this issue. During the food advisory committee’s two-day hearing, they reviewed available data and weighed a number of questions related to food dyes, ranging from whether further research was needed (93% voted yes), to whether foods containing dyes should carry a warning label, as is done in the EU (57% voted no), ultimately upholding a decision initially made in 2010.
Criticism of the FDA’s decision abounds. Among the flaws, critics have pointed out that the FDA focused on food dyes’ relationship to the clinical diagnosis of ADHD versus behavior problems and non-ADHD symptoms such as insomnia (Weiss B, Environ Health Perspec 2012;120:1-5).
But the research thus far has not been strong enough for the FDA to make any firm conclusions. One problem is that the dyes are already on the market and being used and, when that is the case, the burden of proof is to show harm.
If they just wanted to start putting AFCS in food, the burden of proof would be to show safety. It seems likely, in view of the 93% vote that more research is needed, that if the dyes were being newly proposed, the FDA would require more research before approving them. Randomized controlled trials with standard doses and durations of each specific AFC could paint a clearer picture of how they truly effect behavior.
CCPR’S VERDICT: If only it were so easy to simply remove a food additive or avoid it altogether to make ADHD better or prevent the illness in the first place. However, ADHD is more complex and overdetermined than that. Many causes, both genetic and environmental, contribute, and the causes are not the same in all cases. Nevertheless, it seems clear that food dyes have a negative effect on behavior, whether in the context of a psychiatric diagnosis or not. We see no harm and perhaps some benefit from removing artificial food dyes from a child’s diet. And that goes for all kids—not just those with ADHD.