Postscript to Purity and Danger: New Gluten-Free Labeling Rules Go Into Effect

Since I was a bit out of the loop with teaching for part of the summer, I missed the news that the deadline for compliance with the FDA’s new rules for “gluten-free” labeling starts August 1st, 2014. Daniella’s blog post over at Smart Allergy Friendly Education clued me in. You can read her thoughts and questions about the rules here.

Parsing the new standards for a label like “gluten-free” seems a great moment to consider some of the complexity of negotiating questions about purity and danger. I introduced this theme in a more general way in my previous post. As a researcher, this event prompts me to ask a few questions.

How pure is pure enough? 

The FDA’s page about the standards for the public states,

FDA has set a gluten limit of less than 20 parts per million (ppm) for foods that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten.” This level is the lowest that can be reliably detected in foods using scientifically validated analytical methods. Other countries and international bodies use this same criteria, as most people with celiac disease can tolerate foods with very small amounts of gluten.

However, several non-governmental, non-profit organizations already have their own certification programs for gluten-free labeling. Some of them, like those set by the National Foundation for Celiac Awareness and the Gluten Free Standards Foundation, are lower than the new purity standards required by the FDA, at 10ppm or 5ppm and 3ppm respectively. 
I wonder about how the “scientifically validated analytical methods” mentioned in the FDA fact sheet might affect the threshold level they chose. Regulatory agencies in the United States tend to take a less aggressive stances toward regulation because they need to rely on peer-reviewed scientific literature to set their policies. Whatever testing methods they use to set their standards must be the standard procedures and tools for the test being done. “Standard” in scientific measurement and analysis is rarely the same as “the best,” since not every lab – whether it’s an analytic testing company, a private manufacturer, or even an academic research lab – can afford to buy the best equipment. Setting standards based on anything more stringent than the industry standard could lead to pushback – and potentially lawsuits – from representatives of the industries they are trying to regulate. 
This is contrast to a group like the Gluten Free Standards Foundation, who proudly claim, “our commitment to the world is to continue to find methods that allow us to test at the lowest possible limits.

Pure enough for whom?

There’s a wonderful phrase in the passage from the FDA that I quoted above: “as most people with celiac disease can tolerate foods with very small amount of gluten.”
This begs the question, what happens to those individuals who aren’t “most people”?

The logic of protecting “most people” is, in the view of researchers in STS and many related disciplines, typical of public health projects. In the influential book Discipline and Punish, French historian and philosopher Michel Foucault begins developing the point that measuring individuals’ biological status in order to track the average health of the population is central to the functioning of modern states. In his work, “states” refers to higher levels of governments like the federal government in the United States. So while individual outcomes are monitored, what policy makers and regulators seek to control is the aggregated health of the population – its average birth rates, death rates, and rates of disease.

This is a point of view that is dominant in the humanities and qualitative social sciences, and increasingly by scholars with public health training and those who may not have a degree in public health but publish in public health journals. I think it gives some traction for thinking about the mismatch between the kind of 100% guarantee of purity that would offer 100% protection that people with food allergies might desire and the fact that regulators are trying to set standards that are good enough for most people.

Daniella’s blog post which I mentioned earlier raises some more questions about this, too. Take a look!

Who gets to decide – manufacturers, government agencies, or people living with allergies? 

In the United States, the FDA is legally allowed – indeed, required – to police issues of food purity. Other groups can set additional standards, but once the FDA sets a standard, that is the least stringent standard that any grower or manufacturer must adhere to. On a macro scale, the FDA calls the shots on food purity.
Of course, at the micro scale of “what do I eat for dinner?” there is a lot of variability in how much risk individuals want to take on when they eat food – whether that risk is risk of pesticide exposure (choosing organic or conventionally-grown food), risk of pathogen exposure (baby greens? triple washed? or good old head lettuce?), or risk of gluten exposure. If the difference between 10ppm gluten and 20ppm gluten is important to an individual they can make different choices, but depending on their access to quality shopping outlets it may not be an easy task.
In short, there are lots of decisions that can be made by many actors – consumers, manufacturers, and the FDA. Having another set of gluten-free standards complicates the decision tree, creating a certain degree of uniformity but also creating a little bit more wiggle room in terms of purity. While the standards create a floor, individuals may have their own, more stringent standards for the purity of their food. The responsibility for acting upon these personal standards remains with the individual.
Do you trust the people setting the standards?
One of the really interesting things I’ve noticed about gluten-free and allergen-free specialty food manufacturers is how far they go to build trust with their customer base. An example that comes to mind are the tours that were offered by a top-8 allergen food manufacturer to FARE National Food Allergy Conference participants back in June. What better way is there to build trust with customers than by showing them around your factory? As my research has progressed, I’ve observed that allergen-free food companies sponsor all kinds of food allergy-related events, giving them frequent opportunities to educate people about the high purity standards they adhere to to keep consumers with food allergies and similar conditions like celiac disease safe. From the perspective of an observer, this seems like a great way to build trust and credibility in the eyes of (potential) consumers.
But who trusts the FDA these days? Especially among people with food allergies? With the number of outbreaks of foodborne illness, the ambiguity of top-8 allergen labeling, and their general lateness to the gluten-free labeling game, it’s sometimes hard to feel that they have the safety of consumers, and particularly food allergic consumers, at the forefront of their agenda. I have not seen the inner workings of the agency firsthand, so I do not know enough to say for sure. As a member of the general public, though, I see them doing less to build trust with food allergic folks than many allergen-free food manufacturers. On the other hand, they do have the imprimatur of the federal government and the credibility provided by having many highly specialized scientists in their ranks. 
Postscript to the Postscript

I don’t mean for this to be a screed against the FDA. They (along with the EPA and the USDA) are in a very difficult position. United States case law – the accumulated body of legal decisions that lawyers and judges can refer to when making or deciding a legal case – does not make it easy to proactively protect the health of every American. Instead, regulators are in the business of protecting most Americans while trying to avoid retaliation from the regulated industries.

This is my first attempt to jot down some ideas about a “case” that highlights how standards for the purity of food affect the everyday reality of living with food allergies. It’s certainly something I need to keep thinking about and refining.

I would love to hear from anyone who may have been involved in this standards-setting process, or anyone for whom 20ppm gluten sounds like a questionably high threshold for a “gluten-free” standard. You can reach out to me in the comments or on Twitter @allergyPhd!

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