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

First chance to try Starbuck's gluten-free cake, last chance to comment on gluten-free labeling study

We are really, really busy working on the next issue of Gluten-Free Living, but I wanted to take a minute to remind you that tomorrow, May 5, is significant in two ways for those following the gluten-free diet.
First, Starbucks is expected to launch it's new gluten-free Orange Valencia cake nationwide. Not a lot more to say about this than we can't wait! It is supposed to be in the pastry case and clearly marked gluten free.
Second, if you are interested in commenting on the FDA's experimental study of gluten-free labeling the deadline is also tomorrow.
To comment on the Internet go to http://tinyurl.com/cw3s92. So far the FDA has only posted seven comments. I am not surprised by the low number, given how difficult it is to understand exactly what kind of comments the FDA is looking for.
At this point the FDA is only interested in comments on how the study is set up. In about two months, the agency will start to collect consumer input on the actual point of the study, which is to determine what consumers think of labels like "free of gluten," "without gluten," and "no gluten." The FDA also wants to know what consumers think of advisory statements like, "made in a gluten-free facility."
Michael Herndon, an FDA spokesman, said the study is designed to test how effective gluten-free labeling options being considered by the agency are. The FDA is working on a definition for the gluten-free label because it is required to come up with one by Food Allergen Labeling and Consumer Protection Act.
Specifically, the FDA wants to see if study participants understand what gluten-free labels mean or if the labels cause them to make incorrect assumptions about gluten-free food.
About 5,000 people will participate, including those have celiac disease or gluten intolerance or care for someone who does. A review of the public comments should be the last step before a final definition is approved, but the FDA has not said how long that will take.

Amy

Gluten-free consumer survey

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.

Amy