This peer-reviewed commentary criticizes the FDA’s narrow framing, treatment of susceptible subpopulations, and interpretation of effect size. It is a methodological critique, not a new trial or independent replication.
The FDA review confined itself, in essence, to the clinical diagnosis of hyperactivity, as did the charge to the committee, rather than asking the broader environmental question of behavioral effects in the general population; it failed to recognize the significance of vulnerable subpopulations; and it misinterpreted the meaning of effect size as a criterion of risk.
This peer-reviewed commentary criticizes the FDA’s narrow framing, treatment of susceptible subpopulations, and interpretation of effect size. It is a methodological critique, not a new trial or independent replication. The article also records that the committee found the evidence too inconclusive to link food colors to hyperactivity or recommend warning labels. Supported in part by NIEHS grants; author declared no competing financial interests.