Proposed “Gluten-Free” Guidelines: Tell the FDA What YOU Think

This is it, gluten-free people! This is not a drill. The day has arrived for our formerly mute gluten-free selves to speak up and be heard by the Food and Drug Administration about what WE think the label “gluten-free” should mean.

Yesterday (Aug 2, 2011) there was supposed to be a big announcement by the FDA regarding Gluten-Free Labeling Laws (supposedly regarding the enactment of a guideline wherein US foods could only be legally labeled as “gluten-free” if the amount of gluten was less than 20 ppm [parts per million]). But instead of making a finite “here are the new gluten-free rules” announcement, the FDA simply re-opened “the public comment period on its proposed gluten-free labeling rule published on Jan. 23, 2007. What?! We’ve been waiting almost five years for a ruling and *now* they’re getting around to asking us what we think? How long can it take the government to understand what we Celiacs already know: NO amount of gluten, no matter how hard it is to detect with testing, is acceptable for the sensitive Celiac or severely gluten-intolerant person. So the less the allowed amount, the better.

But okay. If they want to know what we, the gluten-free public, think before finalizing their ruling, let’s tell them!! The FDA is inviting “people from local governments, CONSUMERS, the state, and the food industry to offer suggestions and comments about the gluten-free labeling docket number FDA-2005-N-0404″ (FDA Press Release). Here’s a PDF you can read of the official FDA Announcement (it basically just details what gluten and Celiac Disease are, reviews the 2007 proposal, saying that proposal is still valid and talks about reopening the comments).

What’s an acceptable level of gluten? 20 PPM?

So how much gluten is too much? Personally, I say ANY is too much. I say that in order to be allowed to have the term “gluten-free” then it should be truly gluten-free or as close to gluten free as possible. But I understand that this may be unrealistic, that it’s not possible to test for 0 PPM. But why does it have to be as high as 20 PPM? The FDA has deemed that other allergens must have less than 20 PPM. Like eggs, which the FDA ruled must be less than 10 PPM to be safe for the egg allergic. So if something said “egg-free” and the FDA had implemented a 20 ppm rule instead of the current 10 PPM rule, do you think that the severely reactive person with an egg allergy would have a reaction? It would seem the answer would be yes, since the FDA implemented 10 PPM for eggs instead of say, 23 (for peanut) and 30 (for milk proteins). (Stats from FDA website).

So why is it that “gluten-free” should have to be as high as 20 PPM? There are ways to test down to THREE PPM, but it’s more expensive and having it that low would make it much more difficult for manufacturers to pass. Could it be because the health ramifications of gluten aren’t as immediately life-threatening as other allergies? Just because we don’t immediately go into anaphylactic shock due to gluten ingestion doesn’t mean that we don’t suffer. Repeated exposure to the tiniest amount of gluten can increase our risk of certain cancers by up to SIXTY TIMES more than a “normal” person. When just a tiny piece of gluten from simple cross-contamination can have system-wide health ramifications for up to three months (which I learned from Dr. Stefano Guandalini at last months GIG Conference), shouldn’t the FDA consider gluten just as seriously as it does other major allergens? Shouldn’t they want to take advantage of the latest technology and have the lowest PPM possible.

How low can current tests go?

Why can’t the FDA follow what either the GIG (Gluten Intolerance Group) and the Celiac Sprue Association (CSA) have already implemented? The GIG has a Gluten Free Certification Organization  which will only allow less than 10 PPM of gluten. And the CSA has a limit of less than only FIVE PPM to allow manufacturers to display the CSA Recognition Seal. There are tests (like the RIDASCREEN, Ingensa and Neogen tests) that can test much lower than 20 PPM. The FDA itself has documented that there are currently at least EIGHT tests for gluten that can test under 10 PPM and actually three tests that go as low as THREE PPM (Source: the FDA’s document “Approaches to Establish Thresholds for Major Food Allergens and for Gluten in Food” Appendix 4: Evaluation of Gluten Testing Methods). So why should we settle for 20 when we could go as low as 3?!

Okay. So I’m ranting. Sorry. But as I sit here still swollen from a gluten contamination five days ago from a Van’s Waffle that was labeled as GLUTEN-FREE, I’m more than a little upset about labeling laws that would allow ANY gluten. I mean, gluten-free should be just that: completely FREE from GLUTEN. Or at least a little as can possibly be tested for. But since “the proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008” which “has been adopted in regulations by the 27 countries” in Europe, I guess we should be happy to have at least the same as the Europeans. But can’t we do better, people? Can’t the FDA step up and instead of just being late to the gluten-free party like they are, come out with guns blazing and go for at least 10 PPM? When this proposal came out in 2007, perhaps it wasn’t possible. But it’s totally possible with today’s technology. Perhaps it’s more expensive, but it’s possible. And heck, we’re already paying so much more than necessary for the “gluten-free” on our labels already…. Let’s make those manufacturers EARN that 3-4 times price that they charge over “regular” foods!!

<Stepping down from soap box> Phew.

It’s taken nearly five years to just get to this point. And the FDA says that they’re close but before making their final ruling, they want to know what we think. So let’s all get together and tell the FDA our very real, very significant stories about what gluten does to us. Commenting was opened today, Aug 3rd, at noon and will run for 60 days (until Sunday October 2, 2011). You don’t have to say a lot – just a few words if you want. We just need to let them know how many of us are out here and how vocal we can be! If we all comment and express our concern about the state of Gluten-Free in the USA, they’ll see how many of us are out here and realize that we need to enact change and regulate the currently promiscuous use of “gluten-free” NOW.

And hey! Once you’ve submitted your Comment to the FDA, why don’t you copy and paste it into my “Leave a Reply” section below? That way we can all share. :)

So what are you waiting for?! Go write to them- Oh, wait. A link would help, huh?! :) Here it is:

If you would like to submit a comment on the FDA’S proposed Gluten-Free Guidelines, go to this page on the FDA website and click on the big blue “Submit a Comment” button. I’m going to go start my draft right now.

How about you? What do you think about the FDA and current gluten-free guidelines?

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3 Responses to “Proposed “Gluten-Free” Guidelines: Tell the FDA What YOU Think”

  1. katieb 10/12/2011 at 4:20 PM #

    This has been MY soapbox since about 2007 when we started getting really sick on our ‘gluten free’ diet. Much to my horror/surprise—I find there IS gluten in labeled ‘GF’ foods. My entire family of 4 was getting regular doses of gluten—-that landed me in bed terribly sick for 6 weeks and my kids very ill. It is now 2011, and nothing has changed and I personally think never will, especially with Dr. Fasano supporting the 20ppm so that food manufacturers are not too inconvenienced! My husband and I, in fact, are now grain free and embarking on the Specific Carbohydrate Diet because our bodies have been so depleted and our guts certainly have not healed due to ALL of this misinformation since we went GF in 2005. We also are obviously part of the percentage of Celiac’s for which the Standard Gluten Free Diet chock full of replacement grains and packaged foods is not the cure for our symptoms. I wish more people would pay attention to this dangerous precedent the FDA is going to set and speak up!

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  1. What Do FDA New Gluten-Free Labeling Laws Mean? : || : - 08/03/2013

    […] So why 20? Why must we settle for “kinda sick” when we eat 20ppm foods when we could go as low as 3?!  (see more in my article “What’s an Acceptable Level of Gluten” here). […]

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  2. FDA knows that 20 PPM isn’t enough : || : Gluten-Free Gluten - 08/06/2011

    […] basically, if you’re a highly sensitive Celiac, the FDA’s proposed rule for less than 20 PPM is a FAR cry from what they know is safe: 0.01 PPM!!!!!! They’re pretty much saying that in […]

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