Update on Gluten-Free Labeling

It will be at least another year before gluten-free consumers can expect to get clearly defined gluten-free labels on food.

That news came out of a teleconference the FDA held Tuesday to announce that a long-awaited assessment of safe levels of gluten for those who have celiac disease is finally finished and open for public comment.

But after all the years the safety assessment has been cited for delaying a final gluten-free definition, it got little attention during the FDA teleconference with members of the gluten-free community.

In part that's because the FDA coupled release of the safety assessment with an announcement that the agency will open the entire gluten-free labeling proposal to a renewed round of public comment. Details on how to comment are available on the Federal Register.

Callers representing celiac support groups, the medical community, food makers, gluten-free media and consumers wanted to know when the FDA now expects to finalize a definition, how that definition will be enforced and whether it will still be based on a standard of 20 parts per million.

The FDA said it expects to have a final definition by the third quarter of next year. Once its in place, the FDA will develop rules for compliance and could enforce them through warning letters to food makers that violate gluten-free rules, seizures of product improperly labeled gluten free, injunctions and mandatory recalls.

Mike Taylor, FDA's deputy commissioner for foods, said the agency believes the 20 ppm threshold in the proposed definition strikes a balance between providing safe food for those who have celiac disease and enabling food makers to produce a wide range of products at reasonable prices. But he noted that the FDA wants to hear all points of view and to get comments based on information contained in the safety assessment.

While the teleconference included little mention of the safety assessment, the federal register notice outlines the assessment's conclusion that very low levels of gluten, far less than 20 ppm, "would be protective of the vast majority of those who have celiac disease, including the most sensitive."

The 93-page assessment, called the Gluten Report, concludes that less than 1 ppm of gluten in foods protects the most sensitive people with celiac disease and, as a result, protects the largest number of people from harmful health effects related to long-term exposure to gluten.

The FDA in the federal register said decreasing the gluten cut off to much less than 20 ppm could "have an adverse impact on the health of Americans with celiac disease." The agency said it should set a threshold for gluten-free labeling that helps those with celiac disease adhere to a life-long gluten-free diet while also protecting them from harmful levels of gluten.

 Labeling rules that lead to less gluten-free products at higher prices could reduce compliance with the gluten-free diet and result in serious health complications related to celiac disease, according to the agency.

The FDA said the findings indicate that a safety-assessment approach to defining gluten free could lead to a "conservative, highly uncertain estimation of the risk to individuals with celiac disease associated with very low levels of gluten exposure."

Michael Landa, acting director of the FDA's Center for Food Safety and Applied Nutrition, said during the teleconference that the safety assessment was expected to come up with low numbers for safe levels of gluten tolerance. In part, that's because of the kind of studies it includes and excludes for evaluation. In addition it bases conclusions on the most sensitive people who have celiac disease, not the majority that celiac disease experts say can safely eat foods with less than 20 ppm of gluten.

Instead of using the safety-assessment approach, the FDA said the analytical, test-based approach originally proposed for defining gluten free should be used for the final definition. The analytical approach takes into account the reliability of available testing, the FDA noted. Currently there are no reliable tests for less than 1 ppm of gluten.

But even if the analytical approach is used, the safety assessment could  have consequences for gluten-free labeling. The FDA asks whether, in light of the safety assessment, gluten-free foods that contain a trace level of gluten less than 20 ppm need a qualifying statement. For example, the label might also say "does not contain more than 20 ppm of gluten."

During the teleconference the FDA emphasized how important comments on all aspects of gluten-free labeling are and noted that they will have influence on the final definition. Landa compared the value to real estate, where it's location, location, location. "In rule making, it's comments, comments, comments," he said.

Look for more details on the FDA's plans for gluten-free labeling in our upcoming issue of  Gluten-Free Living.

Amy Ratner

A piece of gluten-free cake

Jules Shepard & John Forberger building the cake

In the end it was piece of cake that drew Food and Drug Administration attention to the critical need for specific rules for using a gluten-free label on foods.

Make that an 11 foot 2 inch cake assembled before a grass roots crowd of gluten-free enthusiasts in a downtown Washington, D.C. hotel.

Mike Taylor, FDA's deputy commissioner for foods, told the celiac disease and gluten intolerant audience at the 1in133 cake-building event that he has heard "loud and clear" that they want a definition for gluten free. "We absolutely understand why you are here and why it is important," he said. "We will get it done."

The FDA was supposed to approve a definition by 2008, but it's proposed 20 parts per million gluten-free standard has been in limbo for years. That leaves it up to individuals companies to decide what it means when they use a gluten-free label, from those that use rigorous testing to assure no gluten from cross contamination is in a food or get outside certification that includes testing to others that don't test at all.

Taylor said the delay in an FDA definition comes from a thorough scientific safety evaluation and peer review that has caused the FDA to take a hard look at the proposed 20 ppm cut off for foods labeled gluten free. While 20 ppm is still "on the table," Taylor said the FDA has been investigating whether lower levels should be considered.

When 20 ppm was proposed, the FDA said it was the lowest level for which there were scientifically validated tests that could consistently detect gluten in a wide range of foods. But testing has improved in the past few years, leading the FDA to examine whether it should look at lower levels.

"We want to get it right and we want it to be grounded in science," Taylor said. "This will be the basis for what it safe."

He predicted the FDA in a few weeks will finally release the long-awaited safety evaluation and open it to public comment.

While it's nothing new that release of the safety assessment is the next step in the long, arduous process of  getting a definition for gluten free, Taylor said the clamor for approval now has his attention. "Hopefully this will expedite it," he said.

Credit for the clamor goes to the organizers of the 1in133 cake event, which swelled from email and  Internet conversations between two people with celiac disease who had never met to a movement that has so far generated nearly 9,000 signatures on a petition to the FDA asking for action.

Couldn't resist taking pic with cake

It was all built around the publicity magnet idea of building the tallest gluten-free cake ever. And it was pulled off with spot-on planning and execution by Jules Shepard, owner of a gluten-free flour company in Maryland, and John Forberger, a gluten-free activist from New Jersey, with a little help from a lot of friends. Both could be found straddling icing-spotted eight-foot ladders as they worked feverishly to assemble and ice the tower of a cake right up to the last minute.

There had been a lot of guessing about how tall the cake would turn out to be. In the end it measured 11 feet 2 inches. Since "1in 133" had become such a rallying point for the gluten-free community, cake workers added another inch or so  before they took the cake apart to donate it to a Washington, D.C. soup kitchen.

Final height, appropriately, approximately 11'3.3"

Amy Ratner

FDA gluten-free survey - This just in!

As hard as it is to believe, the FDA already has all of the responses it needs for the survey on gluten-free labeling. The survey will be closed shortly, according to the research group conducting it.

Here's what Katherine Kosa of RTI International said in an email:

"I have learned that people received an ineligible response not because they are ineligible but because we have reached our quota way faster than we expected. We received an overwhelming response to the survey in the past 24 hours and cannot keep up. We will be closing the survey shortly."

I think everyone is surprised that all the needed responses came in so quickly. (We did have one person who commented on my earlier blog that this seemed to be a possibility) The National Foundation for Celiac Awareness only this morning sent out an email encouraging gluten-free consumers to participate. We first heard of the survey and started promoting just yesterday morning.

I can understand how some people feel they did not have a chance to have their say with the survey opening and closing so quickly. Earlier today it seemed that the problem was too many people responding at the same time. In fact, the problem was too many people responding period.

Hopefully, the FDA will come up with a way for those who could not participate in the survey to have their comments heard. One of the positive things to come out of this is the demonstration that those who follow the gluten-free diet have a strong voice and will take the opportunity to use it.

Amy

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.

Amy

Fill out this important FDA gluten-free survey

You can now fill out the long-awaited FDA survey on gluten-free shopping habits. It's available here.

It took the FDA a little more than a year to release the survey, which will help the agency figure out what kind of gluten-free labels those who follow the gluten-free diet want to see.

You can fill out the survey if you are at least 18 years old. It is designed for those who have celiac disease, gluten intolerance, wheat allergies and those who shop and make meals for anyone following the gluten free diet.

The FDA is spreading word about the survey through celiac support groups and it is available on the internet and or by calling 1-877-4GLUTIN1 to request a paper copy.

Questions include:

• the method by which you were diagnosed with celiac disease or gluten sensitivity
• whether and how often you purchase and prepare packaged food that is gluten free
• the kind of symptoms you experienced after accidentally or purposely ingesting gluten
• how difficult you find following a gluten-free diet
• what impact an increase or decrease in the availability of gluten-free products would have on you
• the quality of advice you get about the gluten-free diet from a variety of sources
• how often you look for a gluten-free claim on a product
• how much gluten can be in a food labeled gluten free
• how you would like gluten to be quantified, either parts per million or micrograms per gram

In addition, you have a chance to look at a variety of labeling options, choose the one you prefer and give your opinion about the safety, believability and clarity of another.

The most important part is that you actually take the time to fill out the survey. The FDA has said the survey would not delay approval of a final definition of gluten-free on a label, but all we know is that the deadline is long past and anything the gluten-free community can do to get its approval moving is very important.

Amy

Where Oh Where has Gluten-Free Labeling Law Gone

I just read that The Food and Drug Administration has warned 17 food manufacturers that 22 of their products have labels that violate federal labeling laws. Most make exaggerated or unauthorized health or nutrition claims.

"Today, ready access to reliable information about the calorie and nutrient content of food is even more important given the prevalence of obesity and and diet-related diseases in the United States," FDA Commissioner Margaret Hamburg, MD, said in an open letter to the food industry.

Hamburg in October had encouraged companies to review their labels to make sure they complied with FDA regulations and were truthful and not misleading. Companies that got warning letters have 15 days to tell the FDA how they will correct the labels.


Nutrition labeling is a priority for the FDA, according to Hamburg.

I understand that having accurate label information about total fat in products that contain no trans fat, total juice content in drinks for children, and whether a food can really treat, prevent or cure diseases like hypertension, diabetes and cancer benefits everyone.

But I wonder what ever happened to the poor, forgotten "gluten free" label which has been largely ignored by the FDA even though Congress passed legislation that said it had to be finalized by August 2008. That was 19 months ago - but who is counting. Certainly not the FDA.

The fact that celiac disease is treated solely through the gluten-free diet should give it some priority as a diet-related disease. On top of which, celiac disease is becoming more prevalent as more and more people are getting diagnosed.

The gluten-free definition continues in limbo while experts look at an assessment of studies done on safe levels of gluten for those who have celiac disease. It seems to me they have been looking at it so long it should be memorized by now. Once this endless expert review is complete, the public is supposed to have a chance to comment on the assessment.

Meanwhile, the FDA has also launched what it calls the "Gluten-Free Labeling of Food Products Experimental Study." Basically, the FDA wants to find out what consumers think about various wording of gluten-free labels. The last we heard of the study was in November when the FDA published comments about who should be included in the study and how it should be distributed in the gluten-free community. The FDA said it will ask major celiac centers to recruit participants through mailing lists and posted flyers. And it set a deadline of Dec. 17, 2009 for commenting further on the collection of information. No more word after that.

So the wait is still on for regulation of gluten-free labeling. Meanwhile, we will have to be satisfied knowing the FDA is more diligently protecting us from misleading and false health and nutrition claims.


Amy

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.

Amy