Wednesday, March 18, 2009

My $0.02 on the FDA gluten free labeling survey

I posted the other day about the call for public comment on the proposed FDA survey on gluten free labeling. Today I uploaded my comments to

This study could be really helpful and important. This is the FDA potentially asking us - the people who have to live and eat gluten-free - what we need and want in labeling. Do you want to know where your food comes from and what has been added to it? What if the ubiquitous "natural flavorings" was gone and replaced with the actual contents of the packaged food?!

I am not saying that it would solve every problem, but here is a chance for a large study to be conducted and further substantiate the findings of other studies* that to be able to be able to adhere to the gluten-free diet, persons need clear, concise and adequate information about food.

It sounds so simple, "we need to know what is in food," but like it or not, more often times than not we don't. Just last night I noticed that a product that I have used for 2 years, that was gluten free, now contains wheat. The packaging did not change, there was no warning on it. I have become relatively comfortable, almost lax, about shopping and this snapped me awake again. Like it or not, checking packaging and labels EVERY TIME is a necessity. It would be great if information could be collected about the day-to-day needs of persons who must avoid gluten and hopefully some positive legislation could be enacted.

If you are interested in viewing and posting comments, you can do so by searching for the docket number and then click on the comment bubble to add your own comment.
Docket No. FDA-2009-N-0083

Paper submissions can be sent to:
Division of Dockets Management (HFA- 305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number found in brackets in the heading of this document.
Deadline for submissions is May 5, 2009

Here is my submission:

"RE: Docket No. FDA-2009-N-0083

To Whom It May Concern:

I am writing in response to the March 6, 2009 FDA notice for public comment on a voluntary consumer study entitled: “Gluten-Free Labeling of Food Products Experimental Study.”

First and foremost I would like to say that yes, a study of this nature is not only important, it is essential for the 1 in every 133 Americans who have Celiac Disease in addition to those allergic, sensitive to gluten and persons with Dermatitis Herpetiformis.

In response to your 4 points:

(1) Whether the proposed collection of information is necessary for the proper performance of FDA's functions, including whether the information will have practical utility;


Only the “top 8” allergens are required by law to be listed, currently there are no regulations that require the full disclosure of all ingredients in packaged foods in the US. Gluten is found in: wheat, rye, barley, kamut, spelt, durum, semolina, einkorn, faro and triticale. Since the ubiquitous “natural flavors” is often listed as ingredients and can be almost anything, it is truly difficult to know if a product does or does not contain gluten.

In addition to a lack of information about what is (or is not) contained within a product, current labels are often confusing and contradictory.
e.g. products such as Rice Dream and Benefiber that both contain barely and/or wheat, but are labeled “gluten free.”

Even when packages are clearly labeled, cross-contamination and mistakes cause people to become violently ill. See one of the most recently reported cases where “gluten free” was not: “Children at risk in food roulette: Mislabeling, lax oversight threaten people with allergies” by Same Roe in Chicago Tribune, 21 November 2008),0,506031.story?page=1

(2) the accuracy of FDA's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used

It is essential to get participants who are in the various stages of the gluten-free diet; persons just starting the diet have drastically different needs than those who have done it for many years, where changes to products without adequate labeling of new or different ingredients is often a problem. It is also essential to survey those caregivers who purchase and prepare foods for those who cannot eat gluten. (Parents of young children, food assistance programs, care giving facilities, etc.)
It is also important to survey persons from different ethnic and socio-economic groups because what people can eat and what people should it is shaped by their culture and their wallet.

One challenge will be the fact that many persons who have Celiac Disease and/or gluten sensitivity also have other food intolerances. The needs and questions surrounding good packaging are limited to just whether something does or does not contain gluten. This will skew some responses and survey questions need to be constructed with this in mind.

(3) ways to enhance the quality, utility, and clarity of the information to be collected

-Offer the survey in more than one language.
-Offer a paper version of the survey for those with physical limitation or without access to the internet.
-Products labeled “gluten free” often cost more. This is an important data collection point.
-Offer the results of the survey to the public.

(4) ways to minimize the burden of the collection of information on respondents, including through the use of automated collection techniques, when appropriate, and other forms of information technology.

-Using already developed online survey tools (like allows for customizable data collection and would defray much of the cost of having to start, build and test a database system.
-Using a simple, online survey that allowed for a variety of types of questions (multiple choice and open ended response) would aid in the collection of more accurate date.
-An online survey would also enable the FDA to contact current Celiac Disease Research Centers, ask for them to distribute the survey to their mailing lists. (Beth Israel Celiac Disease Center, CDC @ Columbia, U of Maryland for Celiac Research, American Celiac Society,, etc.) This would further defray the cost of finding participants.

I hope these are in some way useful.

Again, I thank you for your time and concern and am looking forward to the study and its results.

Kristina Nies
Diagnosed with Celiac Disease June 2007"
Comment tracking number is 8091b9f7

A. Sverker, G. Hensing & C. Hallert. “‘Controlled by food’ – lived experiences of coeliac disease.” The Journal of Human Nutrition and Dietetics 18 (2005): 171-180.; and
H.R. Green and Chrstophe Cellier. “Celiac Disease” The New England Journal of Medicine (2007) 357. 1731-1743.; and A.R. Lee, D.L. Ng, J. Zivin & P.H.R. Green. “Economic burden of a gluten-free diet” Journal of Human Nutrition and Dietetics (20) 423-430.


  1. What if the ubiquitous "natural flavorings" was gone and replaced with the actual contents of the packaged food?!

    Yo, I don't (uh, yet?) have food allergies and I think that sounds pretty good.

    It's strange, in this day and age, to see a company add allergens to products.

  2. Some of it has to do with whatever is cheaper. I am going to go out on a limb here and say that it might have something to do with corn being used for ethanol and thus driving up corn prices, so wheat might now be cheaper.

    It was in a liquid soap product. Some people don't have reactions to it, but I rather not find out the hard way. Instead, I found out that if you buy in bulk, you can mix and match flavors of Dr. Bronner's at Harvest! I am the proud user of Citrus-Almond soap.