Sunday, May 03, 2009

My Note to the FDA

I'm Not Sure It Got There, Though!

Last week I finally submitted some comments to the FDA about its proposed gluten-free food labeling research. I thought I'd figured out the submission process, but now I'm not so sure.

Anyway, as promised, I'm sharing it with you as well. I made an effort to address the FDA's concerns, but I have a sneaky feeling that some of my remarks might've been considered off-topic. Still, I hope they're not too crazy—and I hope they provide some food for thought. Here goes!
I am a clinically diagnosed person with celiac disease who has been on a gluten-free diet for more than eleven years. I maintain a blog called Gluten-Free NYC.

I would be glad to see any new, thoughtful research on labeling food to make shopping and dining easier for people on medical gluten-free diets.

My suggestions probably relate most to “ways to enhance the quality, utility, and clarity of the information to be collected.” They are based on my experience, including communication with many others who are gluten-free.

Basically, I encourage you to work hard to make the most of the study by “asking the right questions.”

So please consider the following nine points when formulating your questions:

1. Many labeling discussions involve coming up with labels such as “gluten-free” to represent measurements, but I ask you to please consider the option of also including the actual measurements on labels, perhaps expressed as a range reflecting the variance that can be found when measuring products. Certainly sharing the high-end (or worst-case scenario) of the range should be considered. The University of Nebraska food allergy lab used by the Celiac Sprue Association and directed by Steve Taylor might be a good source of information about taking this approach. Something else to consider is research on the reliability of different measurement techniques, which continue to evolve. A presentation about this was made at the 2006 International Celiac Symposium held in New York City. I think the presenter was Enrique Mendez of Spain’s Centro Nacional de Biotecnologia.

2. Find out what people think “gluten-free” or “gluten” signifies. I think many people might not realize that the main concern about gluten in food has to do with specific medical conditions, not weight control or something proven to be inherently unhealthy for the general population.

3. On a related point: Consider including educational information on labels to explain why people might want to go on a gluten-free diet. This is important in terms of informing the population about celiac disease, a severely underdiagnosed condition, as well as debunking misunderstandings that people might have about gluten in food. The information could be included on some labels, but it could also be offered via a toll-free number and a website. This could boost the dissemination of medically sound (NIH?) information explaining why gluten is being measured in the first place.

4. In preparing this questionnaire, consult with gluten-free associations in other countries (such as Canada, Finland, and Italy) to learn from their experiences.

5. Consider including dates on labels to indicate when they were printed. This could boost consumer confidence about how well products live up to the most recent standards.

6. Look into using label or bar code information to help determine price differences between products and their gluten-free equivalents. There is a possible tax deduction based on the difference, but it can be a burden for individuals to have to calculate a year’s worth of price differences every year. Perhaps this could lead to a standard deduction option for gluten-free diets.

7. Look into using bar code information to enhance consumer ability to research the gluten content of the product and also enhance the ability of retailers to identify which products are suitable for gluten-free diets.

8. Address areas where current allergen labeling has been inadequate. A possible example might be Quaker Oats, which is one of many oat lines that test positive for gluten even though the labels do not warn about wheat content.

9. Question why barley content hasn’t been added to the “problem ingredient” list. It is not one of the main allergens, but it is one of the main sources of gluten contamination, which concerns about 1% of the population.

Thank you for considering these points and good luck in taking swift, sensible actions to assist a growing segment of the population.
Got comments for the FDA? The cutoff date is May 5, 2009.

And thanks to Ben Cappel for #5!


A Levario said...

The notice which appeared a month or so ago was not for the purpose of soliciting public comments about GF labeling.

Rather, the FDA was asking for comments on how it was designing its study and how it planned to collect the data.

We anticipate that the FDA will ultimately pose these questions for such input.

There has been much confusion over this notice from the FDA.

Andrea Levario
American Celiac Disease Alliance

David Marc Fischer said...

Thanks for the comments, Andrea.

I realized that the FDA solicitation was largely technical, but there was that item about “ways to enhance the quality, utility, and clarity of the information to be collected"--and I figured that one way to enhance the information to be collected would be to consider certain issues, such as using high-end measurements of gluten in products, putting dates on the labels, tying the labels in with medical (as opposed to marketing) infomation, labeling oats products that are cross-contaminated, learning from efforts outside of the United States, etc.

I figured I might as well air these points (and also thank the FDA for looking into the subject) in the hope that they might be helpful or at least not be harmful.