Overwhelming response to gluten-free survey may be causing problems

The gluten-free community is responding with such force to the new FDA survey on gluten-free shopping and labeling that some problems have developed.
In short, the 700 responses that have come in in the last 24 hours seem to be swamping the system, according to Katherine Kosa of RTI International, the non-profit research organization contracted by the FDA to conduct the survey.
That might be one of the reasons some people are getting told they are not qualified to participate, Kosa said.

The survey was initially released to celiac research and treatment centers a few weeks ago, but after only 250 responses were received in two weeks, celiac support groups were given the survey link to share with the gluten-free community. Kosa said one group sent out 7,000 e-mails.

I personally have also been urging those who follow the gluten-free diet to quickly fill out the survey and encouraging others to spread the word.

It seems this might have worked too well. Kosa received numerous emails this morning from people who said they were not allowed to complete the survey and did not understand why. She said there were no problems when the survey was first released to the celiac centers and the response rate was low.

But Kosa noted there might be other reasons people are being told they are ineligible to participate.

The survey was designed to collect information from the average celiac and gluten intolerant consumer (including those who shop and prepare meals for someone else who has celiac disease).

It is also interested in responses only from those who buy packaged food and read labels.

“We want people who shop, buy packaged food and read labels. We don’t want the person who knows more than the average (gluten-free) consumer” Kosa said. “We don’t want the ‘right’ answers. We want to know what people know.”

That means you will not qualify if you work for the food industry or a retailer, a gasteroenterologist, a celiac disease support group, a celiac disease research center or a government agency related to food.

You also will not qualify if you say you do not purchase packaged food or have not shopped for gluten-free food in the last month or say you do not read labels.

Kosa said she understands the frustration the survey may be causing. “We know how passionate (gluten-free consumers) are and how frustrating it is to be told you don’t qualify,” she said. Kosa noted that she has talked to the FDA about this and the agency is looking into the possibility of enabling those who do not qualify to make comments in another way. There is no guarantee that will happen though.

The FDA will collect 4,400 responses, which Kosa says is a relatively large number for a survey. That will include responses from consumers who do not have celiac disease or gluten intolerance or care for someone who does. These people will be drawn from an e-panel of consumers. The FDA is interested in their responses because of the increasing number of people buying gluten-free items even when they do not have celiac disease for gluten intolerance, according to Kosa.

The deadline for responding to the survey is April 30, but at the current rate the FDA will reach its limit much earlier than that.

So what should you do if you have not responded or have been kicked off the survey as ineligible?

I would suggest you stop trying today until any problems with the survey can be worked out. Over the next few days, things should slow down, and you will probably be able to get through. Once things slow down, you will know that if you are told you are ineligible, it’s accurate based on what the survey is trying to find out and not simply a system that is over-worked

Kosa apologized for the problems. I do, too, for my role in urging everyone to get moving to fill out the survey fast. I know how easy it is to forget something if you put it off and I know the completion of the survey will play a role in how quickly the definition for the gluten free label is approved.

I think the response rate is an indication of how important this is to those who follow the gluten free diet. But if our enthusiasm overloads the system, it does not really do us any good.

Will “gluten free” be fine in ’09?

It’s hard to believe it’s 2009 and we are still waiting for the gluten-free label to have real meaning. After all, the heralded Food Allergen Labeling and Consumer Protection Act said the label had to be defined by August, 2008.

That gave the Food and Drug Administration four years after the allergen labeling law was passed to get its act together on the gluten-free label. At first, at Gluten-Free Living, we fully expected some kind of definition to be finalized by the August deadline. But as it got closer, we started to realize that the FDA was going to let the date go by without any action.

Personally, I don’t really understand how the agency can ignore a law passed by Congress and signed by the president, but as a reporter I know it happens.

The official reason for the delay is that the FDA is waiting for a report on all the studies that look into a safe cut-off level for gluten in gluten-free food.

Wait a minute, you might be thinking! How can there be any gluten in gluten-free food? But the truth of the matter is there is likely to be a tiny amount of gluten even in gluten-free food because of cross-contamination. For example, gluten-free flour can have traces of wheat flour in it because of the way grains are grown, transported and milled. It’s just a farming fact of life.

Researches have tried to measure when these traces trigger damage to the villi of those who have celiac disease. The FDA is looking at studies from this kind of research to see if a proposed level of 20 parts per million — a very small amount — is the safest cut off.

There’s nothing wrong with that. Nobody wants a label that allows an unsafe level. I’m just not sure why the FDA waited so long to look at the studies.

Another complication is that FDA recommended 20 ppms because there was no reliable test for any smaller amount that could be used for all kinds of gluten-free food. So much time has gone by, even that might have changed.

The FDA isn’t a real talkative agency. It’s very hard to get information from them. And now that the agency is under fire for not doing basic things like going after food companies that list flour instead of wheat flour on a label — a violation of the allergen labeling law — it’s unlikely they will open up about what’s going on with the gluten-free definition.

Some have expressed hope that the new presidential administration, with a newly appointed head of the FDA, will change things.

That’s my biggest hope for 2009. No matter what else happens in the changing gluten-free world, I hope that we will finally get the gluten-free label we all need. Certainly it will cause some upheaval for gluten-free companies that will have to test their products to prove they can meet the cut off. Surely we have right to be dubious about how the FDA will ever enforce the law behind the label. But without it, “gluten free” means many different things and that’s not good for those seeking a healthy gluten-free life.