
FDA Comment Number : EC1468
Submitter : Mrs. Cleo Wolfe Date & Time: 09/20/2005 06:09:01
Organization : Mrs. Cleo Wolfe
Category : Individual Consumer
Issue Areas/Comments
September 19, 2005

Dear FDA:

Please draw the line at zero tolerance with regard to gluten-free food labels. Logically, a product either contains gluten or it does not contain gluten. Anything above 0 means the product contains gluten.

With regard to a safe amount of gluten, gluten is toxic to people with celiac disease and gluten sensitivity. It stands to reason, then, that no gluten is a safe amount. Research has demonstrated that <5 mg of gluten per day is toxic to some patients. If, as Europe allows, food makers can label foods with 20 mg/100g, or 200 parts per million (PPM), as gluten-free, then those sensitive to this amount will be harmed.

?Some countries have what are called Rendered Gluten-Free products. Basically that's using wheat starch. They try to extract as much of the protein out of it to take the gluten away from it. Their standard for a product marked Rendered Gluten-Free will be 200 ppm. This is kind of right on the threshold for some people, so those foods are not permitted to be imported into the US. However, in other countries they are used as part of a so-called gluten-restricted diet. In some patients that's enough to trigger symptoms. One study done in Montreal, Canada, using rendered gluten-free products in children, found that half of them had to give up that diet and go back to a naturally gluten-free diet because of symptoms.? (Dr. Carol Semrad, Assoc. Prof. Medicine, U. Chicago)

Would you label a product as peanut-free if you knew some peanut-allergic people would die eating the food? Celiac disease is a serious autoimmune disorder that damages the body and leads to injury and eventual death. The reaction may be delayed, but it still occurs. Nevertheless, no damage could occur if foods labeled gluten-free are 100% gluten-free.

It is ridiculous to suppose that foods cannot be 100% gluten free. Do not cave in to food lobbies, businesses or ignorant health organizations. It is already difficult enough for newly diagnosed patients to follow a gluten-free diet, especially if they are asymptomatic. How much more difficult will it be to follow the diet when foods are mislabeled as gluten-free when they actually are not? I, and others like me, do not want to live in fear of gluten-free labeling.

This is my life. I take it very seriously. I hope you will as well. Vote for zero tolerance in gluten-free labeling.

Thank you,

Cleo Wolfe