On Friday I started digging into the FDA’s proposed gluten-free regulations. We talked about the PPM that the FDA is setting up: 20 PPM is currently the proposed threshold under which a food can be accurately labeled gluten-free.

Today let’s delve deeper, shall we? Setting a threshold is one thing. Communicating that threshold to consumers is another. This is one of the areas of the rule that the FDA seems most eager to hear comments about – it doesn’t matter whether you’re a scientist or a hair-dresser or a birthday party clown, if you eat gluten-free food the FDA wants you to be able to shop knowingly and safely. And who better to tell the FDA what you want to see on a label than you?

The rule itself (you can get to it by clicking on the link above) states that:

FDA also seeks comments, data, and any other information related to the issue of whether a ‘‘gluten-free’’ claim on foods that contain a trace level of gluten greater than 0.01 ppm but < 20 ppm should be qualified in a way to ensure that the claim is truthful and not misleading…

…For example, an asterisk could be placed immediately after the term ‘‘gluten-free’’ (i.e., ‘‘gluten-free*’’) on a food label or in food labeling, with a clarifying statement located in close proximity to that claim in a print size no smaller than 1⁄16 of an inch (e.g., ‘‘does not contain 20 ppm or more gluten’’ or ‘‘does not contain 20 micrograms or more gluten per 100 grams food’’). In light of the safety assessment, and because FDA previously received very few comments on this issue, we are soliciting public comments again on whether it would be necessary to accompany any ‘‘gluten- free’’ labeling claim with the addition of qualifying language. Also, we request comments on the wording for any qualifying language and on its proximity to a ‘‘gluten-free’’ claim appearing on a food label or in food labeling…

The proposal also states that the FDA is not considering any sort of low-gluten threshold, for example for items that are 20-100 PPM, because they “did not have sufficient scientific data to recommend such a level.”

That’s the easiest part to digest, so let me ask the first question: do you think there should be a low-gluten label in the US? Personally, I tend to agree with the FDA’s current leaning away from such a label. I know there ARE many foods that might be 25 or 40 PPM and that most celiacs could safely eat them in small quantities without adverse effects – but it just seems like too much to juggle without constantly worrying.

Second question: are the words “gluten-free” enough? Should there be an explanation of the FDA’s definition of gluten-free on every label? If so, what is the appropriate phrasing? How close does it need to be to the words ‘gluten-free’ on the packaging?

It’s worth noting that items that are labeled fat-free, for example, may contain up to a certain amount of fat and don’t have to call this out on their label. Of course no one has a fat intolerance, so it’s a bit different – but I still tend to think that any extra wording is unnecessary. You?

Another question worth considering is that of foods like polenta or rice that are inherently gluten-free. What kind of labeling should inherently gluten-free foods have, if any? Let’s imagine a company that only sells rice. Their rice has only one ingredient: rice. Under proposed rules, if they choose to adopt the gluten-free label, the rice must have less than 20ppm gluten. If they do not print the words “gluten-free” on their label, then there is no limit to the amount of gluten that could be inside the package.

It could be 0ppm, it could be 500ppm – and it will be up to the individual consumer to decide whether or not to purchase the rice. The ruling doesn’t go into statements like ‘made on shared equipment,’ so questions of cross-contamination will still remain. While I’d love to see all manufacturers who don’t include gluten-containing grains on their ingredient list be required to test for gluten, I’m not sure how feasible this is.
What do you think?