In the United States, 20 parts per million (ppm) has become commonly accepted as the maximum ratio of gluten levels in food deemed safe for people with celiac disease. This premise stems from the U.S. FDA’s rule for packaged foods issued in 2013 that aimed to help both people with celiac disease eat more safely and the food manufacturers produce foods to documented standards.
How did 20 ppm become the guideline for gluten levels in food?
The cut-off value was partially selected because this level can be accurately and precisely measured by validated testing methods.This is reasonable from the manufacturers’ perspective, since without a reliable way to determine the gluten levels in foods they are producing, it would be very difficult to comply with the rule. Imagine driving through a school zone, but your car’s speedometer could only display zero or 100 miles per hour. It would be challenging to drive below the 25-mph speed limit without any accurate feedback.
But from the consumers’ perspective, especially those with celiac disease, concentrations as close to zero parts per million would be ideal, and this is where the other components of the FDA rule come into play. For a packaged food to be rightly labeled “gluten-free,” it not only must have less than 20 ppm of gluten, but also may not contain gluten-containing grains, or gluten-containing grains where the gluten protein has not been removed, or grains where the gluten protein has been removed but the use of such ingredient results in greater than 20 ppm gluten in the final food. To continue with the car analogy, this would be equivalent to saying, yes, the speed limit is 25 mph, but we would prefer for the safety of the children, that cars drive as slow as possible (or no cars be allowed on the road).
When developing Nima, our primary concern was to detect gluten at levels of 20 ppm, with a high level of certainty, since that is the FDA ruling. But as we thought about the problem, there was a biological, chemical and engineering challenge, as well as a philosophical dilemma. From a scientific perspective, to detect a certain quantity, the test must be designed with margin of safety, so we had to develop a test that could detect well below 20 ppm. And this is an achievement that we are all proud of accomplishing. We have developed the first and only easy to use, portable and connected solution available to consumers.
However, with the ability to detect below 20 ppm, the philosophical question became, if we detect gluten below 20 ppm, should we report it gluten-free? We asked ourselves, is there really a significant difference between 21 ppm and 19 ppm? For example, in a 2016 study by Cochrane Australia, researchers did a systematic review to “determine if there is a threshold level of intake of gluten that is safe for people with coeliac disease to consume.” They concluded that “The studies highlight the individual variability in tolerance to gluten and the difficulty this raises for setting a safe threshold…In the absence of larger randomised trials that compare small amounts of gluten intake, the current evidence precludes establishing a definitive threshold level of gluten that is safe for all people with coeliac disease to consume.” Simply, the evidence we have to date is not sufficient to set a level that is safe for every person with celiac disease.
In addition, if you take a look at the organizations that certify food as gluten-free, they all have different standards for sticking their “certified gluten-free” label on a packaged food. The Gluten Intolerance Group, for instance, requires that a food tests at or below 10 ppm to use their familiar certification label, even though the FDA only requires at/below 20 ppm.
Every body is different. We have customers reach out and mention they get sick from certified gluten-free foods as well as people from other countries that have stricter labeling laws than the United States. So what would be best for our community?
In the end, given the wide diversity of foods that Nima can test, and with our community’s best interest in mind, we decided that if Nima detects any gluten levels in food, any non-zero ppm, Nima will report “gluten found.” Ultimately, our goal is to tell you if Nima detects gluten, and the goal of food producers should be to make foods that are truly gluten-free.
-Francisco Dias Lourenco, VP of engineering, Nima