April 1, 2011

Dear Feingold Friends,

I am writing this from Washington, DC, where we have just completed attending the FDA Hearings on Artificial Food Dyes, where the Food Advisory Committee Panel listened to scientists and other experts (including me as your representative) for two days. Thursday, the public also had the opportunity to present their view and experiences. Immediately after, the Panel began its deliberation on the charges as set forth here.

They spent the afternoon discussing several questions on which they were required to vote. They were not happy with the wording on most of the questions. For example:

Question 3 asked whether the 1982 NIH Consensus Development Conference conclusion was still relevant. This question includes all this:

  • for some children with both ADHD and a confirmed food allergy, dietary modification has produced some improvement in behavior

  • elimination diets should not be used universally to treat childhood hyperactivity (with or without the presence of food allergies), since there is no scientific evidence to predict which children may benefit

  • initiation of a trial of dietary treatment or continuation of a diet in patients whose families and physicians perceive benefits may be warranted.
The Panel was required - by a one-word YES/NO vote made by clicking a button - to determine whether these statements are "still relevant today."

In their discussion, the Panel members pointed out that the statements were almost 30 years old and that accepting them as "still relevant" gave the appearance of no progress; that they had not discussed food allergy at all, and could make no such determination; that if they were to vote YES, then it also meant they were voting that diet should not be used "universally" but if they voted NO, then it also meant that they had voted that diet did not work and that those who benefit could not be encouraged to continue. They also pointed out that they had not discussed "diet" but only "food additives." Nevertheless, they were required to make a single YES/NO choice, after being warned to "be careful" how they voted.

They voted YES - to accept the statement as "still relevant" - apparently because to not do so would be worse.

One must wonder how many FDA lawyers it took to draft these questions.

The main one, of course, Question 4, was whether to advise the FDA to require warning labels on products containing artificial food dyes. Actually, they were again required to vote YES or NO on a question that asked "what additional information, if any, should be disclosed on the product label..."

Points brought up by the various experts as they deliberated included the need to protect American children, the assurance (by FDA advisors) that if they find out later that warnings are not needed, they can be removed, and the worry about whether using the word "may" as in "may cause behavioral problems in some children" would overly scare parents. Indeed, they had a lengthy discussion on variations of possible wording for the proposed label. One panel member suggested simply updating the FDA website to include a warning, while another pointed out that many people don't or can't visit the FDA website, but they all go to the grocery store. After what proved the longest discussion of the afternoon by far, the vote was taken .... we held our breath ... but unfortunately the vote was 8 to 6 against -- warning labels lost by one vote.

When finally arriving at Question 5 - requiring more research - the entire Panel, with the exception of one member, voted YES with no hesitation. There seemed to be general acceptance of the British studies as "robust" with the regret that the inclusion of sodium benzoate prevented them from accepting fully that it was the artificial food dyes causing the behavioral changes.

Although we are disappointed to lose the warning labels, we do feel that there was a significant advance in understanding of the situation over the course of the testimony - far more than we had expected, given the background information originally prepared by the FDA for the Panel members.

At FAUS, we are already considering the best next step to take.

Thank you.

Shula Edelkind
Website Communications
Feingold Association