ExecutiveDirector Mary Schluckebier
Public Hearings resulting from passage of The Food Allergen Labeling and Consumer Protection Act of 2004

Issues on the national scene have dominated my activities on your behalf since the last Lifeline. The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) led to two public hearings this summer. The hearings were held by the United States Food and Drug Administration (FDA) in order to determine the necessary regulations to support the law.

The July public hearings were devoted to “threshold information” for allergens, gluten and celiac disease. The first day was devoted to food allergies and the second day was devoted to celiac disease. The testimony presented showed that any scientifically acceptable research which confirms “how much is too much?” is woefully lacking. The testimony also showed that the minimum level of an allergen or gluten that does NOT evoke an immune response is a major concern for those with food allergies and celiac disease. Patients from both groups vocalized sup-port for a regulation which supports both personal food choice AND a zero level of allergens and gluten. I also reported that CSA membership surveys show that about half of those with celiac disease responded that, besides celiac disease, they also have one or more other food sensitivities.

To write a viable regulation one expects to be able to determine and set a measurable standard to represent the minimal amount allowable. What is the magic number? No peer-reviewed and published research was presented to the committee to clearly identify a minimal amount of “gluten” or its components that would evoke an immune response in people with celiac disease. Such research does not exist. Each evidence-based research study that touches on this area seems to bring the elusive threshold closer and closer to zero. No clear-cut answer to a threshold level emerged.

CSA President Tom Sullivan and I formally volunteered both the mem-bership and CSA as an organization to help provide information, research and volunteers leading towards meaningful regulations and a greater knowledge base for celiac disease. As the largest celiac organization in the Western Hemisphere, we have an opportunity to help provide much insight into the celiac patient and celiac disease.

The August public hearing sought input to help the FDA define and permit the voluntary use on food labeling of the term “gluten-free.” The hearing focused on food manu-facturing, analytical methods, and consumer issues related to reduced levels of gluten in food as illustrated by the following questions:

  1. What should “gluten-free” mean on a food label? Why?
  2. How do you identify foods that do not contain gluten?
    How much time do you spend identifying “gluten-free” foods?
  3. What percentage and types of foods that you buy are marked “gluten-free”?
  4. Does “gluten-free” printed on a product label influence your decision to purchase products having the same ingredients? To what extent?
    Example: Two cans of tomato sauce on the shelf both contain only tomatoes and salt and only one is marked gluten-free. As a result of the hearing, the FDA formulated a NEW QUESTION.
  5. Would you consider a two or more level definition of gluten-free helpful?
    Example: Level A might mean the absence of any wheat, barley, rye, oats and any of their derivatives. Level B might mean the presence of trace amounts, less than “X” parts per million, of wheat, barley, rye, oats and any of their derivatives. Level C might mean the presence of small amounts, less than “Y” parts per million, wheat, barley, rye, oats and any of their derivatives. (“X” and “Y” identify quantities in parts per million to be determined by the FDA.)
    I, as CSA Executive Director, was one of the three invited presenters in the consumer issues portion of the hearing. I explained the general decision-making CSA32005 No. III • CSA Lifeline • www.csaceliacs.org • (877) CSA-4-CSA steps for successful self-management of celiac disease that persons with celiac disease use to maintain health. With a lifelong disease, decision-making goes through various stages as one grows in experience, knowledge and changes in health status. People develop individual coping habits. It was important to express how very much those of us with celiac disease welcome a meaningful, verifiable and consistent definition for “gluten-free.” People with celiac disease want to be able to differentiate between products that contain WBR (and at this time O) and those that do not. I showed label examples from companies that clearly list what is IN their products and noted how this helps us immensely in making knowledgeable choices.
    The results from the CSA Membership Survey of 2005 were also mentioned. The 1,200 responses were the basis for providing responses to the initial FDA questions.
    Overwhelmingly, CSA members returning the surveys over the past two years want the definition of gluten-free to be “free of wheat, barley, rye, oats, and any of their derivatives, and any cross contamination.” No matter what one considers their personal level of sensitiv-ity to “gluten” we are of one mind in wanting a strict definition of “gluten-free” for making personal food choices.

 

I was also asked to speak about the CSA Seal of Recognition for those companies that are the “best of the best” in providing a product that is truly suitable for those with celiac disease. The criteria are foods items that are free of WBRO, WBRO de-rivatives and cross-contamination in product, processing and packaging.

Nine people spoke in the public portion of the meeting, including CSA President Tom Sullivan. A very few people expressed the opinion that oats should be considered gluten-free and not excluded with WBR for a gluten-free definition. Only WBR were listed in the FALCPA.

Many thanks to the FDA staff who are working to develop a regulation that will protect our segment of consumers. It is mandated that by August 2006 the FDA must propose a regulation for the voluntary use of “gluten-free.” Again there will be a designated period for public comment before the final definition becomes a regulation in 2008.

Since only comments submitted to the FDA Docket become public record and are considering in the development of the regulation, CSA mailed about 12,000 postcards to CSA members and friends providing the information about responding to FDA questions. As of August 25, over 22,00 comments had been filed with the FDA.