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Comment Period Reopened on Gluten-Free Labeling

Four years after the Food and Drug Administration proposed guidelines for gluten-free labeling, the issue of what qualifies as “gluten-free” is back on the table.

Today the agency is reopening the comment period for its rules on gluten-free labeling, which were drafted in 2007 but have not yet been adopted. 

“We want to get the most up-to-date information and data from affected consumers, from the food industry, researchers and others to ensure that we’re making the right public health call in defining gluten-free,” said Michael Taylor, FDA Deputy Commissioner for Foods, during a call with stakeholders Tuesday. 

An estimated 3 million Americans suffer from celiac disease, which prevents the body from absorbing essential nutrients in food after consuming gluten, which is found in grains such as wheat, barley and rye. 

“We want to make sure that those suffering from celiac disease avoid adverse health consequences from being exposed to food that may trigger the symptoms and cause long-term health effects,” said Taylor. 

The law under consideration stipulates that any food with the label “gluten-free” on the package must contain less than 20 parts per million of gluten. 

That’s the equivalent of about 2 grains of salt in a piece of bread, says Rhonda Kane, Consumer Safety Officer in the Food Labeling and Standards Department of the Office of Nutrition, Labeling and Dietary Supplements, who says this image is a good visualization tool, not an exact measurement. 

For those who worry that this small amount, when consumed at low levels over an extended period of time, could amount to a dangerous level of gluten, Dr. Stefano Gandalino of University of Chicago Medical Center, an expert in celiac disease, says that there are no studies showing that 20 ppm can build up to harmful levels. 

“Ten mg [the equivalent of the suggested level] ingested every day by any celiac patient, in any of the studies that I’m aware of, done in any part of the world, are completely safe,” he said during the phone conference Tuesday. 

The current recommendation includes a peer-reviewed assessment of the existing literature on gluten safety.

FDA invites the public to comment on how much weight the study should be given in determining the definition of the term “gluten-free,” in addition to the 20 ppm threshold for the term. 

“I think it’s vitally important to understand that the comments we get on proposals and on records are critically important to how we proceed in this and other matters,” said Michael Landa, acting director for the Center for Food Safety and Applied Nutrition (CFSAN), during the news conference.

The decision to accept further input on gluten-free labeling rules comes weeks after U.S. Senators Ron Leahy (D-VT) and Ron Wyden (D-OR) wrote a letter to FDA demanding that the agency act on its long-stalled gluten-free regulations.

Taylor says the FDA needed time to review all the facts related to gluten safety.

“The time elapsed since the original proposal has been devoted to the evaluation that we committed to doing when we published the proposal, and this involves the safety assessment,” he says. “It was a painstaking process to develop that report and then it was subject to a peer review.”

The celiac disease community approved the decision to reopen the comment period, saying that it will allow FDA to take new information about gluten intolerance and celiac disease into account.

“Much has happened in the gluten-free world since then and, without reopening the comment period the FDA would not have been able to take that information into consideration in making a final decision on the standard,” said Andrea Lovario in an e-mailed statement to FOod Safety News.  “One of the most important things, was that the Codex Alimentarius, a standard used in international trade, was changed (moved down) to 20ppm.  Many GF products that celiacs in the U.S. enjoy are made outside of the U.S. and meet that standard.”  

In Europe, food with less than 20ppm gluten is considered “gluten-free,” while food with between 20 and 100ppm is labeled “low gluten” in 27 countries. The U.S. has not yet proposed a threshold for low gluten, but this is one of the issues that FDA hopes stakeholders will comment on over the next 60 days. 

The rules are expected to be finalized in the third quarter of next year, says Taylor.  

“Companies that understand the gluten-free consumer, that their needs are due to a medical condition, will, we hope, take whatever standard is set very seriously and conform,” says Levario. “We hope that will adopt strong safety protocols as well to ensure that the products regularly meet or exceed the final FDA standard, as lives depend on the end product being safe.” 

The proposed regulations for gluten-free labeling can be found in the Federal Register under docket number FDA-2005-N-0404 at www.regulations.gov

 

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  • The damage done by gluten is NOT dosage related. Celiac is a one-molecule disease…not a 10ppm disease. The damage done by 1 molecule is the same as that done by eating a slice of bread. Gluten must be absolutely removed from foods.