Archives – FAWA 1979, July

Dr. Feingold comments on the FDA study

The Kaiser-Permanente/University of California study funded by the FDA is commonly referred to as the FDA study.

The study was supportive.

One child out of 22 children under controlled conditions reacted unequivocally to a challenge with dyes at a statistically significant level.

On the surface the immediate reaction of the FDA, as expressed in their state and also in the UPI release was that dyes are not important; only one child in twenty-two showed a positive response.

However, this is a distortion and misinterpretation of the study. Let us examine the facts:

  1. The primary objective of the study was to confirm that food additives do cause hyperactivity.
  2. There are several thousand chemicals eliminated by the Feingold Diet. It is not possible to identify each chemical at fault in each child, since the diet is applied in blanket form empirically. If a child adheres to the program, the chance for a favorable response in behavior is 60 to 70 percent. Which specific compound is involved can usually not be identified precisely to meet academic standards.
  3. In view of this complexity the study focused upon the six dyes commonly encountered in our food supply, since these can be controlled to a greater degree than the remaining additives.
  4. The children were screened with a modification of the Feingold Diet. What guarantee is thare that even one of the 22 children must be reacting to dyes, or BHT, BHA, flavorings or salicylates? Accordingly, it is remarkable and most fortunate that even one child reacted to the dyes, at a statistically significant level. This means the chil served as its own contol and was not compared to the group.
  5. Since only one child reacted, the FDA and UPI drew the fallacious conclusion that dyes are not important. They ignored completely the objective of the study and the inability to draw such a conclusion from the study. The importance of the dyes related to other factors was not studied. That will come later after many years of expensive research.
  6. Another blatant weakness of the study is the dosage of the dyes permitted by the Human Rights Committee. The children were only challenged with 37.5 mg of the dyes, which is not realistic. Actually, some children require 100 mg or even 300 mg as demonstrated by Swanson. Since the response is pharmacological one and not allergic, the adverse reaction is dose-dependent. WITH ENOUGH DYE EVERYONE WOULD RESPOND (emphasis added). However, the amount required for any given individual will vary with the bioavailability of the compound.
  7. The FDA statement and the UPI release state: “The findings tend to support the conclusion that, while some behaviorally disturbed children may respond to some aspect of the Feingold Diet, the elimination of synthetic food colorings from the diet does not appear to be a major factor in the reported response of a majority of these children.

This a a false conclusion and cannot be deduced from this study. In brief the study is positive, even in the FDA statement. We have now crossed the most important hurdle – Do additives cause hyperactivity? The answer is, Yes!

We now must have many many more studies, particularly at the biochemical level, and perhaps on animals, in order to unravel this very complex problem. The FDA plans to sponsor additional research.

In the meantime, we can empirically get the children well without risk, without harm, and without exploitation. We need not await the final conclusion which will require many years, perhaps even a generation or two.

Ben F. Feingold, MD

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