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
