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
3 comments:
Truly an excellent summary, Amy!
Although I deeply appreciate the actions of our various celiac groups on our behalf, I believe that using a two-tiered system such as the ones adopted by Australia and New Zealand will create standards that are very natural and intuitive, and will eliminate confusion for everyone whose lives are impacted by celiac disease, including people who do not have an informed understanding of what it means to be gluten free. There is nothing prohibitive or confusing about it if it is done correctly.
Toward this end, I very much prefer labeling “celiac safe” those products of 20ppm or less and saving the term “gluten-free” for products that actually are, either because they are naturally so or because, in the future, testing allows such proofs.
A very big benefit of a two-tiered system such as “celiac safe”/”gluten free” is that it can be used in perpetuity, as technology improves and changes, without causing confusion in the marketplace for consumers or producers.
We shouldn’t only be adapting to conditions now; we should be preparing for conditions in the future. With a two tiered “celiac safe” and “gluten free” system, “safe” means safe and “free” means free. This labeling will be easy, intuitive, clear, simple, flexible and forward-looking for every participant in this industry, consumers most of all.
Also, at one point in this process, the intention was that gluten-free labeling would be voluntary rather than mandatory. I believe gluten-free labeling should be mandatory, just like the labeling for the top eight allergens is mandatory.
I totally agree too - it was VERY easy in New Zealand to figure out what I could eat as the labels there I believe were gluten free and low gluten - and that was almost 15 years ago that I was there working!
There is a thought though for following what the standard is in the world - which is gluten free for those with CD and like NZ (I do not think AU does the two labels) the low gluten for those who choose to eat GF but are not at the standard Celiacs have to adhere to.
You are bang on with your comment about comprehending what it means to be actually GF and have CD - I have been battling that for 30 years!
Right now with testing at 3ppm, and the world standard finally at 20ppm when the US adopts it, then there will be no confusion for travellers or visitors from other countries on what it means.
Canada has a zero tolerance legislation that their testing, which currently is 3ppm and as low as you can get, can just get lower without changes to the Health Act.
And to think, just after I was diagnosed, the WHO standard was less than 200ppm which most of the world followed! That is what led to legislation changes in AU, NZ and Canada to adopt less than 20ppm oh so many years ago.
It is nice to see our southern neighbours doing the same.
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