From: Elaine Bradshaw [ebradshaw@salud.unm.edu]
Sent: Tuesday, August 23, 2005 5:59 PM
To: Dockets, FDA
Subject: 2005N-0279

To whom it may concern:

I am writing to you as a physician and a person with celiac disease/gluten intolerance. 

I believe that "gluten-free" on a food label should indicate no gluten in the food, unless the amount of gluten present falls, of course, below the sensitivity level of the test being used to identify it. I say this because persons with celiac disease differ widely in their sensitivity to gluten, so that even a tiny amount may make a person with gluten sensitivity ill- analagous to food allergy. I also say this because even if some small amount of gluten doesn't overtly make ther person sick, it is still causing inflammation in the small bowel, with possiblities of consequent nutritional deficienies, other health problems, and - ugh!- a much increased risk of small bowel cancer (an illness with a BAD prognosis).

I currently am overjoyed if I find a product labelled "gluten free" as it saves a lot of time! I've had this illness for years, but I still spend hours a week reading the backs of boxes, cans, etc to find safe products; even if I know a given product has been safe, companies are forever changing their recipies and formulations, so I still have to read. 

If I knew for certain that gluten-free meant gluten free, I'd definitely be more apt to purchase that product than a similar unlabelled one. That is because of time saved, but also because even products that don't have gluten containing ingredients listed sometimes still contain gluten due to cross contamination in factories, production lines, etc. I hate playing gluten roulette, and so end up ordering expensive gluten free items from dedicated gluten-free producers off the internet. It beats vomitting and losing weight!

Alessio Fasano's 2003 multicenter study of celiac prevalence in the US revealed a prevalence of 1 in 133! I think that says clearly that this is not a rare illness, and that it's time to start labelling for it.

Thank you for your consideration,


Elaine Bradshaw MD
Assistant Professor
Assistant Director, Pediatric Residency Program
University of New Mexico

phone (505) 272-2345
fax (505) 272-2374
MSC 10 5590
I University of New Mexico
Albuquerque NM 87131-0001