2005N-0279 Food Labeling; Gluten-Free Labeling of Foods; Public Meeting
FDA Comment Number : EC11
Submitter : Mr. C.R. Schmink Date & Time: 08/03/2005 02:08:52
Organization : Mr. C.R. Schmink
Category : Individual Consumer
Issue Areas/Comments
I propose that the most rigorous existing 'gluten free' standard in the rest of the world be used in the United States - and at the earliest possible date.

While there is a European 'standard' of sorts (Codex Alimentarius), it is weak - and therefore potentially dangerous to people with celiac disease.

A much more appropriate standard is found in Australia. The following comments come from:

http://melba.vu.edu.au/~rhh/gffoodsintro.html .

'In Australia, current standards on food labelling are that for a product to be labelled 'gluten free' it must contain 'no detectable gluten' which means that it must be less then 0.003% (30 ppm). If a food is labelled as 'low gluten' it must contain less than 0.02% (200 ppm).
The current International Codex Alimentarious Standard for gluten free products is the same as Australia's 'low gluten' standard.'

Please note the huge difference between the Australian 'gluten free' standard and their 'low gluten' standard (equivalent to Codex Alimentarius). For people with celiac disease, 'low gluten' would be much the same as 'low latex' or 'low peanut' for those with severe latex allergies or those with peanut allergies - and could result in death within minutes for those people. The only difference is that with celiac disease, the death process is much slower (such as the resulting development of Non-Hodgkin's lymphoma from celiac disease). And there are many other conditions associated with celiac disease that are not immediately life threatening, but that degrade quality of life and shorten it - osteoporosis, malabsorption, etc.

What is essential is this country catching up to others that are way ahead. After the University of Maryland studies confirming the far higher frequency of celiac disease among Americans than was previously believed, it is even less understandable that there have not been protections put in place long ago. It should not be the responsibility of every single individual who has celiac disease to not only become expert at reading labels, but also having to individually write to companies to learn the ingredients in their 'natural flavoring,' 'caramel color,' etc., or to pharmaceutical companies every time they start to take a new medication of some sort - or switch to a generic from a name brand. It may be easy for non-celiac patients to simply not think about the time, effort, and money involved in staying strictly gluten free. But for very real human beings it becomes a constant hassle, limiting the range of foods they can even eat and wasting considerable time studying most any food label, then still having to write letters to companies for individual answers.

So in less formal language, come on -- catch up to smaller, less wealthy countries and give us a break to enjoy a more normal life that you take for granted every single day of your lives -- and ours. Set a standard that meets or exceeds the most stringent in any nation, **NOT the Codex Alimentarius.** And please require labeling to ensure that components of foods obtained from various sources by the final product manufacturer be included in 'gluten free.' To say that a cereal company is 'cleared' because they don't manufacture their artificial flavors, etc., is no excuse. Let
them do the homework we've been forced to do ever since we began to realize just how prevalent gluten is. They should be the ones to query their suppliers - that's part of what we should be paying for when we purchase their products. In fact, anything that goes into the food chain in the U.S. should be certified gluten free or non-gluten free in order to eliminate the uncertainty not only for consumers, but also end-stage producers of our foods.

Thank you for your consideration.

C.R. Schmink