FDA’s Gluten-free Labeling Laws, Part 2

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?


13 thoughts on “FDA’s Gluten-free Labeling Laws, Part 2”

  1. I studied abroad for a semester in Brazil and every packaged good sold had to say whether it contained gluten or not on the label. This made grocery shopping so much easier, especially since the ingredient lists were in a foreign language! It would be so nice to have the same laws here regarding labeling.

  2. Allowing food companies to state “Gluten Free” on front product label should ONLY be allowed if that company is testing the product. They should not be allowed to state gluten free, then use the CYA statements on back label like: Processed in a facility that also processes wheat. or Processed on shared equipment. etc – – essentially, they are currently allowed to state gluten free if the ingredients are gluten free, regardless of whether or not there are cross-contamination possibilities in the processing or packaging. That is just wrong.

  3. I believe that using a two-tiered system such as the ones adopted by Australia and New Zealand will create standards that are very natural and intuitive, and will eliminate confusion for everyone whose lives are impacted by celiac disease, including people who do not have an informed understanding of what it means to be gluten free. There is nothing prohibitive or confusing about it if it is done correctly.

    Toward this end, I very much prefer labeling “celiac safe” those products of 20ppm or less and saving the term “gluten-free” for products that actually are, either because they are naturally so or because, in the future, testing allows such proofs.

    A very big benefit of a two-tiered system such as “celiac safe”/”gluten free” is that it can be used in perpetuity, as technology improves and changes, without causing confusion in the marketplace for consumers or producers.

    We shouldn’t only be adapting to conditions now; we should be preparing for conditions in the future. With a two tiered “celiac safe” and “gluten free” system, “safe” means safe and “free” means free. This labeling will be easy, intuitive, clear, simple, flexible and forward-looking for every participant in this industry, consumers most of all.

    Also, at one point in this process, the intention was that gluten-free labeling would be voluntary rather than mandatory. I believe gluten-free labeling should be mandatory, just like the labeling for the top eight allergens is mandatory.

  4. I am gluten intolerant. I get a severe reaction to products containing gluten. I recently purchased Amy’s Gluten Free Pizza. The pkg. said manufactured in a facility that uses wheat. Well, there must’ve been cross contamination because I became vey ill after eating this pizza. Diarrhea, dry heaves, abdominal pain and I became completely dehydrated. This should not happen with a product labeled “Gluten Free”. I e mailed the company but never received a reply. I think Gluten Free products should be “Gluten Free”. I cannot afford to be that trusting of labels that say mfg. in a facility that uses wheat. I used to be but not anymore since that recent experience. If it says gluten free and celiac friendly, I would tend to believe that product.

  5. It would be great if it was uniform and consistent. My daughter can not eat things that are made in a plant with wheat and so the “Celiac safe” would be nice. I am happy to see so many companies labeling these days but I still have to go with – if I am unsure then I don’t get it. As far as things being labeled Gluten free with “made in plant with wheat” as an aside on the back is misleading. To me gluten free means – no wheat – at all – even cross contamination. Is it nice to see gluten free on products that are naturally gluten free – yes, I think for those who are just being diagnosed or buying for someone who is GF and does not know then that is a nice guideline.

  6. I believe that ALL consumers should have to list if the product is gluten free and yes, that also should relate to cross conatmintion possibility as well. Its not gluten free if it had the possibility of cross contamintion to be a factor. Then, it wouldnt be a guessing game or shopping with your cell phone game(calling mfg’s)…it would be a no brainer, if it doesnt state gluten free then dont purchase it. It should state GLUTEN FREE very clearly so it will be easy to spot. Why should people with celiac have to work so hard for their groceries? Why should you have to do detective work just to shop for your food? I feel if you are mfg food products it should have to be tested regardless so that each and every item will be clearly and truthfuly stated . Donna

  7. I agree very much with Donna Curtis. We should not have to be detectives. It takes a lot of time to contact each manufacture of food products. We recently missed with a product that had no ingredients containing gluten listed but it did have gluten when we contacted the company.

  8. So the FDA is finally adding gluten and not just wheat–yippee!!! Maybe my congresspeople have listened afterall. Being a diagnosed Celiac with episodes of Psychosis which I am been recently told is a result of my Celiac Disease, I want the labels that say Gluten-free to mean absolutely no gluten. This less than 20 whatnot doesnt seem to apply to extreme cases like myself. So if it has any Gluten at all–label it, not to mention govern it and regulate it properly from the farm to the supermarket to the restaurants. Thank you for this update. Sounds like another letter writing campaign is on the horizon.

  9. Please, please submit these very valid concerns to FDA. They are currently taking comments until October 4th when a ruling will be determined. E-Comments
    You can submit your comments through the FDA Website at regulations.gov The document ID is FDA-2005-N-0404

  10. I believe every product should be marked “Gluten Free” or “Not Gluten Free”. I believe that a product packaging for rice, that maybe naturally gluten free, should state if the product is produced and packaged in a Gluten Free environment. Even if a product is labeled Gluten Free, it should state “less than 20ppm” or “more than 20ppm” for those that are more sensitive. I believe that all modified food starches should be ID’d on the label for its source, such as corn or wheat. A statement should be made on labels that appear gluten free, but all the ingredients are not guaranteed produced in a gluten free environment. It could read, “Ingredients are not verifyed Gluten Free by the manufacturer.” All labels should have a telephone number consumers may call to verify allergens, NOT just an address. Makeups, such as, lipsticks should be clearly labeled “Gluten Free” or “Not Gluten Free”. NO LOW GF labels should be on products. This is like telling a person there is only a small amount of poison in the food. This would be dangerous to Celiacs who may not have strong symptoms.

  11. I think it would be nice if a product tht says its “gluten free” ,yet contain up to 20ppm of gluten they should put how many ppm’s u would consume per serving. Tht way if any celiacs eat two diffrnt products claimng to be gluten free in a day they can still stay under the 20ppm required to be safe. I can’t handle the 20ppm myself, 0 ppm is what I need, been sick for to long

  12. If a product has ANY gluten in it, it is NOT gluten free. A speck makes my wife ill, therefore, this labeling will lead to more illness since someone will think a product is safe, when, for them and many others, it is not. Gluten free, should actually mean gluten free.

  13. The use of descriptions such as “processed in facility” and “shared equipment” is very useful to me, because it means i can’t buy it. Maybe some people can but I can’t. I appreciate that this is on the label, but I always wonder if every manufacturer is required to use this terminology (I have seen many, many products with oats and just assume they are made on shared equipment, whether they state this or not). When i see “tested for gluten” I heave a sigh of relief. So common language such as “shared facility” “shared equipment” “allergens–wheat” is good enough for me, but only if everyone is REQUIRED to list this. (The allergens information should also include barley and rye, not just wheat….)..

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