From: Sarah F. Day [cesd@az.rmci.net]
Sent: Friday, December 14, 2001 9:29 AM
To: FDADOCKETS@oc.fda.gov
Subject: Phoenix (AZ) Celiac Support Group Comments 8/10/01

                                                                                                                                                                    Ms. Nina Spitzer 
                                                                                                                                                                    President, Phoenix Celiac Support Group
                                                                                                                                                                    5478 E. Cholla St.
                                                                                                                                                                    Scottsdale, AZ  85254
                                                                                                         
                                                                                                August 10, 2001      

                                                                      
The Dockets Management Branch (HFA-305)
Food and Drug Administration
5630 Fishers Lane, rm. 1061, 
Rockville, MD 20852

    As President of the Phoenix Celiac Support Group of Arizona, I, on behalf of this organization, would like to submit comments regarding current efforts by the Federal Food and Drug Administration to revise the current food labeling rules for your Aug. 13, 2001 meeting.   Our organization membership includes those suffering from celiac disease and their immediate families.  We have over 100 members at the end of our first year and membership is rapidly growing.  There are similar organizations throughout the country.

    First I would like to explain this disease.  Celiac disease (CD), which affects approximately 1:150 people in the United States, is "a genetic disorder affecting children and adults. People with celiac disease are unable to eat foods that contain gluten, which is found in wheat and other grains. In people with celiac disease, gluten sets off an autoimmune reaction that causes the destruction of the villi in the small intestine. Celiac sufferers produce antibodies that attack the intestine, causing damage and illness."  (University of Maryland Center for Disease Research 8/2001 web site www.celiaccenter.org/)   There is no cure, medication to provide relief, or corrective surgery to correct the effects of this disease.  The only successful treatment is lifelong adherence to a gluten-free (GF) diet which, given current food labeling standards, is very difficult.  For those of us suffering from this disease, continued ingestion of gluten-contained products even in small quantities leads to malabsoption in the small intestine, damage to the villi, which is very painful and which leads to malnourishment and complications such as lymphoma, even death.  For these reasons, celiacs across the country are extemely concerned about the ambiguity of the current food labeling rules.  Every person, from birth on, who is diagnosed with CD must purchase gluten-free products, always, or suffer the consequences.  Therefore, we strongly recomend the following: 

    Comment 1:  We ask that manufacturers identify more clearly all ingredients that may or do contain gluten or derived from gluten in                                 wheat, rye, oats and barley, including, but not limited to : vinegars, starches, malt, natural ingredients, colorings, spices.
 
    Every man, woman and child with celiac disease buys or does not buy each food (and detergent, make-up...as well) product based on food labeling.  If the food label is ambiguous, and most labels are, most members of this group will now call the company, if we can ferret out their phone number.  Most large companies like Frito-Lay now understand what GFmeans, are quite helpful and now provide gluten-free food lists.  This has been enormously helpful.  We buy only those foods that we know are verified gluten-free (GF).  If we err once, we can be quite ill for a between several hours and several days due to the body's reaction (similar to that of poison).  And the more errors, the higher our chances of serious long-term health consequences as mentioned above.  Finding out if a product is GF is a time-consuming, often frustrating task now, but it shouldn't have to be.   

    It is clearly financially advantageous to companies to comply with this labeling change.  A few companies have refused to say that their product is or is not GF, likely due to lack of knowledge or possibly due to fear of legal action.   Changes in food labeling requirements should help.  If a company is uncertain about a food source because, for example, they may have possible cross-contamination during the manufacturing process, (i.e. conveyor belt not thoroughly washed before a line change), then their food label should say that the food "may contain gluten", as is done for peanuts at times.   It would be even better if they thoroughly clean the belt and avoid the problem, but this is not always possible, we realize, for other reasons.  

    Comment 2:  We ask that you consider using the term "intolerance" along with "allergy", and "contaminant" rather than, or in addition to                                 "allergen", and educate all involved about celiac disease.   This is not an allergy. 

    Comment 3:  Cross-contamination during food production is just as much of a health issue.  Labels should therefore                                                                indcate the possibility of cross-contamination during production wht the words "may contain gluten."  We do hope that in the                              near future this issue will be eliminated with improvements to quality-control.

     Comment 4:  Testing is a proven way to eliminate questions.  We would support the testing of products for gluten in federally-funded                                       laboratories.  If testing were required by each company, the cost for the small companies could be prohibitive.   Also, this                                   is  a national problem, and certainly a growing one.   

     Comment 5:  We support the idea of adding an 800 company contact phone number on each food product and are grateful to every                                       company already providing one.   

    Than you for your consideration of our comments.  Thanks also to all of those who have worked on this issue.  Your efforts thus far are truly appreciated by all of us with celiac disease.  Should you have any questions, please contact Ms. Sarah Day at (480) 315-8193.  We are planning to submit further, more comprehensive comments before the Oct. 29 deadline, but hope to have this at the table for the Monday, Aug. 13 meeting.  

                                                                                    Sincerely,  Nina Spitzer
                                                                                                        President, Phoenix Celiac Support Group
                                                                                                        5478 E. Cholla St.
                                                                                                        Scottsdale, AZ  85254