On Wednesday, the FDA reopened the floor for discussion about their proposed gluten-free labeling.


This is a very good thing. This is why there were giant cakes baked, marches marched, petitions signed, etc. And the fact that the FDA is open to comments and interested in listening to what we all collectively have to say about our health – even better.

It’s also a very detailed thing. Before you comment – and the more comments the better – it’s important to understand what it is you’re commenting on. Which is why we’re going to take a few posts to dissect the proposed legislation and what it means.

First things first, the source material:

  • The FDA’s press release has a good set of links and an overview, OR…
  • Go to www.regulations.gov and type the docket number into the search bar: 2005-n-0404
  • This will bring you to a whole bunch of documents. The most important is the Proposed Rule itself, which is specifically listed as 2005-n-0404-0135 (if you just want to cut to the chase, enter that number into the search bar)
  • Other documents you might want to look at include reference 3, which is a peer-review of some of the data analyzed by the FDA.
  • If you want to read the data itself, it’s tougher to find. But I love you all, so I found it. Click here for the PDF.

Second things second, the time frame:

  • You have until Oct. 3 2011 to comment. There is no benefit to commenting early, so take your time.

OK, so the contents of the rule itself. At the end of the day, the FDA is setting up

  • a PPM threshold
  • a means of labeling food to clearly explain the threshold
  • a general understanding of which grains are likely to be problematic
  • methods for determining whether or not a given food does in fact meet the threshold

Today let’s just talk about the first bullet.

The proposed threshold is 20ppm. In order to reach the number, the FDA looked at the few things. First, 20ppm is in keeping with the Codex Alimentarius and most international standards and is easily and accurately detected by a variety of methods.

Second, it should allow for a reasonable amount of gluten-free food available in the marketplace. The proposal clearly spells out a fear that if the threshold were too stringent, somewhere closer to 0ppm, most manufacturers would be economically forced to either close up gluten-free shop or raise prices to a point where no-one can afford the food.

They also reviewed extant studies that examine how much gluten a celiac can tolerate daily. Those studies don’t point to one clear magic number that works for all celiacs, but they do point to most celiacs being unharmed upon ingesting 0.4 milligrams per day.

The FDA then made some guesses about how much non-0ppm food an average celiac might ingest on a given day. They also assigned a flat ‘contamination number’ to this food for the sake of measurement. In reality, Susie might eat 7 different things that contain different trace amounts of gluten in a given day, and 2 on a different day – but for the sake of the study, the FDA assumed that Susie eats the same food with the same amount of gluten every day. On that diet, a 20ppm cap will keep Susie under 0.4mg gluten.

To be continued, but in the meantime: what are your preliminary thoughts on the FDA’s proposal?