FDA’s Gluten-free Labeling Laws, a Closer Look

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?

8 thoughts on “FDA’s Gluten-free Labeling Laws, a Closer Look”

  1. I think it’s great that this is moving forward. While I understand that it is economically (if not merely practically) unfeasible for a manufacturer to reduce gluten contamination below 20ppm, I’d be interested in having an estimate of how much gluten is in a product. For example, if a product is routinely tested (to qualify for gluten-free labeling) and has results in the 8-10ppm range, I’d love to see that on the label right under where it says “gluten-free”. I’m assuming some products might actually be completely gluten-free (i.e. 0ppm) while others might be closer to the threshold (20ppm). If I was able to see what typical test results were for the product right on the label, it would be easier for me to make informed choices about what I’m eating.

    I was diagnosed with celiac disease in January of this year. My blood test results were so extreme that the doctor told me they were the highest she had ever seen. I am 28 years old and have suffered from various ailments for many years–migraines, chronic fatigue, mind fog, and a slew of other problems that many people thought were “just in my head”. I have been gluten-free ever since diagnosis, but my recovery has been slow. The greater my ability to make informed choices about what I’m eating, the greater my chances of improving my health and getting my life back on track.

  2. ppm is, indeed, important
    However, what they allow food companies to PRINT on their label is equally important! They would not allow a product to state “Peanut Free” on the label, if on the back of the jar, in small print, it said “Processed in a Facility That Also Processes Peanuts”! Yet this is allowed for gluten? I’ve been nailed so many times by products like that, until I finally started only buying prepared foods that state “Certified Gluten Free.” Really, why should it be OK to double me over with abdominal cramps, sending me back and forth to the bathroom, making me sick to my stomach, kill all the living villi in small intestine, and open me up to a multitude of other auto immune diseases?

  3. So true. Super markets are posting GFon their shelves, but the item is produced in a facility that shares equiptment with wheat. or as you said it’s in small print on the box somewhere. Along with strick guidelines about labeling, GF products should have safe handling and cooking instructions on them to emilinate cross-contamination. there are people who buy and prepare GF products who are not themselves on the GF diet so they are not sensitive to handling and cooking safely. or maybe a number to call for instructions or a website to contact with basic info on Celiac Disease and basic cooking and handling instructions. _Darlene “where ever I go, I try to make it easier for those who come after me!”

  4. Hi, I am a US citizen currently living in Sweden. Here you can go to any restaurant and the waitresses know off the top of their head what is and is not gluten free, average citizens have more awareness and knowledge of celiac disease than the doctors I encountered in America. To me it seems as if congress and the FDA are just being arrogant. Instead of looking at the system that the European Union has set up, which is practically flawless, possibly making some adjustments to that system and implementing it in the states, they are taking their sweet time. The fact that they are concerned with cost and difficulty for food manufactures to meet the standards of gluten free instead of really focusing on people’s health as the priority is worrisome as well. Our government needs to stop thinking that they know best about everything and needs to figure out how to learn from other countries who sadly are much farther ahead in both research and food labeling/manufacturing standards.

  5. I hope everyone who posted comments also takes a moment to send those same comments to the FDA during this “open for comments” period they are having. They need to hear all of this.

  6. I’m concerned about this 20ppm standard. I personally need to know if a product I buy has any gluten, as I’ve had reactions to products that were listed at 6ppm (a European product, as we don’t list ppm on items for sale). If the concern is for human health, why set a standard that will have some celiacs getting sick, and others just making it? (as long as they haven’t had multiple portions of things that are 20ppm in a day) This seems crazy to me! Get the gluten out! Or I’m going to have to eat only out of my own kitchen or move to Europe…

  7. I think I is a great idea to state on a label, under gluten free, the ppm that the food actually tests out to be. I am pretty sensitive and try to eat zero gluten. It might not be helpfull to have a gluten free claim on a label if I still have to call the company to confirm a product is 100% gluten free not just mostly gluten free.

  8. Better labeling is a great and positive thing.most of the people on gluten free diets may actually need simply to eliminate processed and refined foods from their diets.i don’t think they all have the afore mentioned disease.

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