American Celiac Disease Association

[Lisa]

Below please read the recommendations from the American Celiac Disease Association, as the comment period ends today (October 3, 2011) to the FDA, regarding the proposed Gluten Free Labeling legislation.

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Conclusion

There is no medical intervention for the treatment of celiac disease, no drug, no ongoing

therapy. The treatment, while medically prescribed, is self-administered and in many

instances without medical oversight. Gluten-free foods, in all forms, are the equivalent

of a prescription medication used to manage another lifelong, chronic condition. The

laws differ dramatically with regard to the labeling, and manufacturing between drugs

and foods, and we do not imply the two should be equal.

We do however, implore the FDA to consider the following: it takes an individual, on

average, six years of being ill, of bouncing from doctor to doctor before being properly

diagnosed with celiac disease. Gluten-free foods don’t undergo years of safety testing

before going on the market, like medications. Each and every day, celiac consumers

are placed at risk when trying to determine if the foods intended to maintain their health

are safe. They have only the clarity and accuracy of the labeling on which to rely. It is a

heavy burden, but one that will be eased dramatically with the completion of this

rulemaking.

FDA Deputy Commissioner for Food, Mike Taylor, stated in the teleconference to

stakeholders announcing the reopening of this NPRM, and in the press, that the agency

‘must get this right.’ We cannot agree more and believe that reflecting on the experience

of other countries, the FDA can determine the approach to gluten-free labeling which

best protects and works for the American celiac consumer.

Again, we appreciate the opportunity to comment on these proposed rules and look

forward to working with the FDA to ensure their timely and smooth implementation once

finalized in the third quarter of next year.

Respectfully,

Andrea

Levario,

J.D.

Executive Director

American Celiac Disease Alliance

2504 Duxbury Place

Alexandria, VA 22308

info@americanceliac.org

www.americanceliac.org

703.622.3331