I’ve followed gluten-free labeling for a long time for Gluten-Free Living.
I’ve covered hearings and public meetings where I was the only press representative. And I’ve learned a few things about the Food and Drug Administration along the way.
That might explain why I had more questions than answers after I read the FDA announcement about the “Gluten-Free Labeling of Food Products Experimental Study.”
The first was, what the heck does that title mean?
Simply put, the FDA is going to survey about 5,000 people to see what they think of certain statements printed on the packages of gluten-free products. Examples given by the FDA include “no gluten,” “free of gluten,” “without gluten,” as well as “made in a gluten-free facility.” The FDA also wants to know how consumers think naturally gluten-free products should be labeled.
My second question was, why is the FDA doing this study now?
Congress approved the Food Allergen Labeling and Consumer Protection Act in 2004. This law gave the FDA four years to come up with an official definition for the gluten-free label on food. But when the deadline rolled around seven months ago, the FDA wasn’t able to meet it.
The FDA has already held a public hearing, gathered consumer comments, come up with a proposed definition of 20 parts per million, and completed a review of how safe that level is for those who have celiac disease.
The only thing that stands in the way of final approval of a much-needed standard for gluten-free food in the US is public release and comment on that safety review.
Suddenly, it seemed to me the FDA was going back to the beginning to ask people what they want on labels of gluten-free food.
I thought that question was asked and answered in 2007 when the FDA first detailed a “gluten free” label proposal and then collected public comments on it. The proposed definition already deals with the question of naturally gluten-free foods, saying that they can only be labeled gluten free if there is also a note that all foods of the same type are gluten free. For example, a can of peaches labeled gluten free would have to say all canned peaches are gluten free.
I started to wonder if the survey was just a way to put off final approval of the gluten free label even longer.
One of the things I’ve learned about the FDA is that speed is not usually a high priority. And neither is answering questions about documents full of confusing, technical language.
But I did finally get a response from a spokesman who said the survey is not expected to delay approval of the gluten-free definition. He said it’s something completely separate and that the FDA just wanted more insight on how people with celiac disease and those who take care of them interpret different statements that food makers might put on packages. He did note that if survey results are in before the gluten-free definition gets final approval, consumer comments might cause the FDA to make some changes.
I couldn’t get more information than that.
So I still have questions – why is the FDA asking about terms like “no gluten” or “free of gluten?” They seem pretty simple and self explanatory. Even if food companies use those words instead of “gluten free” they would still have meet the standard set by the FDA.
Would the FDA include a requirement that the 20 ppm standard be spelled out every time the gluten-free label is used? And is it possible that the restrictions proposed for naturally gluten-free foods might be lifted?
I’m not sure why statements about strictly gluten-free manufacturing facilities would be terribly important because once a definition is approved the bottom line on all food labeled gluten-free is that it can not contain 20 ppm of gluten or more. That’s true no matter what kind of food processing plant it’s made in so the dedicated facility statement seems unnecessary to me. But I don’t know if consumers or the FDA will see it that way.
Whatever the consequences of the consumer survey, I hope the FDA was giving it to me straight when I was told further delay won’t be one of them.
