Friday, September 30, 2011

Our Comments to FDA on Gluten-Free Labels

Following is the letter Gluten-Free Living sent to the Food and Drug Administration regarding proposed rules for gluten-free labeling.

The deadline for comments is this coming Monday.You can send your comments to the FDA here. Click on "submit a comment" and type FDA-2005-N-0404 into the search bar. On the next page that comes up,  about halfway down, click "submit a comment" next to the gluten-free labeling notation

 However, if you want to sign onto the 1in133 and American Celiac Disease Alliance letter, you only have until noon Sunday. The groups need some time to get all the signatures into a form they can then submit to the FDA.
Meanwhile, we thought you might be interested in what Gluten-Free Living had to say about some key points regarding gluten-free labeling:

As publishers of the first magazine exclusively for those who follow the gluten-free diet, Gluten-Free Living has long been a witness to the confusion gluten-free labeling causes. The lack of any definition for what is gluten free leads to many questions from our readers.

Our experience with the diet and our knowledge of the medical research related to celiac disease, leads us to support 20 parts per million as a valid standard for use of the gluten free-label. The best research to date shows that the vast majority of those who have celiac disease can safely consume products with less than 20 ppm of gluten.(1)

A standard stricter than 20 ppm of gluten has not been proven to be medically necessary for most people with celiac disease. The 20 ppm standard has been accepted internationally after a long review by the World Health Organization’s Codex Alimentarius. (2)

We are familiar with the point of view that gluten-free should mean “zero” gluten, but we know zero gluten is impossible to achieve or test for in the real world. So setting zero as a standard has little meaning.

A standard set lower than is medically necessary for the vast majority of those who have celiac disease and gluten intolerance could have the effect of decreasing the availability of gluten-free food. This would unnecessarily make it more difficult to comply with the gluten-free diet. In Australia, where the amount of allowable gluten is lowered each time tests get more stringent, this is already happening. (3)

If the standard for gluten free labeling is set at less than 20 ppm consumers can then assume that food labeled gluten free might have trace amounts of gluten (between a theoretical zero and 20 ppm). The addition of statements spelling out that minute levels of gluten might be present in gluten-free food would be redundant and add to consumer confusion without any real benefit.

The use of a two-tier system, with” gluten free” and “ low gluten” labels tied to different levels of allowed gluten, was debated and rejected when the gluten- free definition was first proposed. The idea was originally rejected because it is confusing to gluten-free consumers and that is still the case. We continue to oppose use of a low-gluten label.

The question of whether naturally gluten-free foods should be allowed to use the gluten-free label without saying all food of the same type is also gluten free is a little harder to answer.

For inherently gluten-free one-ingredient foods like milk, eggs, canned fruit and vegetables, the risk of gluten contamination is generally so slight, we can realistically assume all foods of this type would be gluten free. So a statement saying all foods of this type are gluten free would generally be accurate. It would also prevent companies from trying to falsely imply that their naturally gluten-free item has some advantage over other brands. Gluten-free consumers have complained about food makers trying to take advantage of the gluten-free fad by putting the gluten free label on all types of naturally gluten-free products.

Naturally gluten-free grains might be in a slightly different category. Grains have a higher risk of being cross-contaminated because of shared fields, transport vehicles and processing machinery. A recent small study showed that some inherently gluten-free grains were highly cross contaminated by gluten-containing grains. (4)

However, the study was based on a small number of samples and even the authors state that general conclusions about gluten-free grains cannot be drawn from it. So it is not yet clear that there is enough evidence to differentiate between naturally gluten-free grains and other inherently gluten free foods when it comes to gluten-free labeling. A larger study into cross-contamination of gluten-free grains is needed. If such a study showed wide-spread cross-contamination, the FDA should allow food makers who take steps to prevent cross-contamination to label their products gluten free without saying all other grains of the same type are also gluten free.

Overall, a medically justified gluten-free threshold that can consistently be verified through testing is what’s needed most by those who have celiac disease.

This threshold should not unnecessarily decrease the availability of gluten-free products and make it harder to comply with the gluten-free diet. We believe the 20 ppm standard satisfies these requirements and we urge the FDA to quickly approve it. Until then, those who rely on the gluten-free diet as the only way to treat celiac disease are left on their own to figure out what is safe. This is an untenable situation that has existed for far too long.

1.Catassi C, Fabiani E, Iacono G, et al. A prospective, double-blind, placebo-controlled trial to establish a safe gluten threshold for patients with celiac disease. Am J Clin Nutr 2007;85:160–6.


3. Price G, Maintiaining Our Food Choices, The Australian Coeliac, 2010, December, 31-33

4. Grace T, Lee A, Thompson T, Gluten Contamination of grains, seeds and flours in the United States, a pilot study, Journal of the American Dietetic Association 2010, June, 814 -976


Marcia Kitt said...

Thank you for the time and care you put into this! The letter is clear and the links are helpful. Your leadership is appreciated.

Marcia Kitt said...
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