2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC1387
Submitter : Dr. Betty Bernard Date & Time: 09/20/2005 06:09:34
Organization : USC Keck School of Medicine - retired
Category : Health Professional
Issue Areas/Comments
GENERAL
GENERAL
Edited version>delete previous one! FDA Docket No. 2005N-0279 9/18/2005
fdadockets@oc.fda.gov

1. WHAT SHOULD GLUTEN FREE MEAN ON A LABEL. WHY? Gluten-free should be defined as NO Gluten, and it is not a product produced in a plant where airborne contamination could occur, or where the same equipment is used for Gluten containing products.

The less than 20ppm serves industry more than the patient - at what point is the cellular damage is tweaked by what level of gluten has as many answers as how many people respond to the same e.g. sunburn dose - due to multiple genetic factors present. State the <20 ppm gluten may be in product - as they do for peanuts now.

The risks for increased secondary manifestations of autoimmune disorders and malignancy are too great to be arbitrary about what gluten-free means. I will advise patients to only select Gluten-Free items. I am a celiac of 71 years and unwilling to have a " touch of gluten", or even a touch of pregnancy.

2. HOW TO IDENTIFY GLUTEN FREE FOODS? TIME SPENT/?
Reading labels is a constant past time at the markets - which doubles time spent shopping very often. When I cannot discern the gluten-free status of a vaguely labeled item, I leave it on the shelf. When dining out - simply broiled meats and vegetables are safest unless one can have a long talk with the chef before ordering. Fresh vegetables/fruits/meats and fresh frozen vegetables/fruits are the most used, but labels scrutinized carefully for products used to dust items to keep from caking or glazed in any way. If a stomachache/diarrhea occurs - then lesson learned and put it on the NO list. The latter is a dangerous way to determine gluten-free status of products.

Hospital dieticians are the most poorly informed - I have to have a snicky fit with them and the pharmacists again and again, and then supply to them my own regular medications, bread, broth, etc. items. Hospitalization is a real nightmare that the entire celiac community has had to deal with ? being poisoned in the hospital by gluten. The doctors and pharmacists are usually no better informed than the dieticians. They put/see gluten-free diet on the orders and they take away milk, butter, fruit, everything you might be able to eat, but they do not forget the roll or gravy ? or a slice of manufactured turkey, ham etc. which has been glued together with a gluten product. I order plain hamburgers to avoid that, or broiled chicken. Fake crab has gluten in it and most of the soy/terryaki sauces they use have wheat in them. It is a crapshoot at best to remain gluten free in the hospital ? so labeled foods/meds just might help the patient to survive while they are in the hospital to avoid becoming sicker because of sheer laziness and stupidity about a gluten-free diet/medications.. Personally, my arthritis flares nastily when in the hospital because of this. Please have all labels state mean Gluten-Free.

3. WHAT PERCENTAGE OF FOODS AND WHICH TYPES ARE MARKED GLUTEN-FREE?
Health food stores 2-3%, Safeway, etc., <0.05%.
Breads, corn, rice, bean pastas, cookies, flours are the most common with a gluten-free designation. Dairy products have none, but so many of the
yogurts have food starch, cereals have malt and barley syrup, medications have coating on tablets, fillers, etc. Problem is that when you call manufacturers - you must ask what are ALL of the ingredients - not only those on the present label. You cannot ask if an item is gluten-free for they usually do not know what they are talking about.

4. DOES GLUTEN-FREE PRINTED ON A PRODUCT LABEL INFLUENCE YOUR DECISION TO PURCHASE PRODUCTS HAVING THE SAME INGREDIENTS? TO WHAT EXTENT?
100% influence to purchase the gluten-free labeled item.