FDA knows that 20 PPM isn’t enough

I was just doing a little “fun light reading” (lol) on the latest gluten articles on the FDA website and saw this lovely tidbit. Question 11 in the Q  ‘n’ A about the proposed gluten guidelines reads:

11. What were the findings of the safety assessment?
Based on the data and other variables included in the analysis, the safety assessment resulted in an estimate that a level of 0.01 ppm gluten in food would be protective of even the most highly sensitive individuals with CD. This estimation of risk to individuals with CD associated with very low levels of gluten exposure may be conservative and highly uncertain.

So 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 their research they’ve found that if you’re highly sensitive to gluten, it only take two tenths of one part per million (0.02) of gluten to have adverse health ramifications.

So I’ll have to ask again… why is the FDA sticking with a 20 PPM when there are tests that can go down to 3PPM? Check out more thoughts on about how much is too much (20 PPM? 10? 5?!) here.

We need to let the FDA know that since far less than one part per million can trigger ill health in a sensitive Celiac, we want the gluten-free guidelines be as low as we can possibly test with current technology: less than 3-5 PPM, not the proposed 20 PPM. The technology is available to detect that low (see my post on that here). So leave my site and go submit your comment on the FDA’S proposed Gluten-Free Guidelines now. Go to this page on the FDA website and click on the big blue “Submit a Comment” button. You don’t have to write much, just let them know that we want, no, we NEED less than 20 ppm. The more of us you Comment, the more they have to listen!!

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3 Responses to “FDA knows that 20 PPM isn’t enough”

  1. Si 10/20/2011 at 12:37 PM #

    Well despite a very careful avoidance and food label reading, I have been triggered by Lucazade and Swedish Glace icecream, I discover that even though labelled as “gluten free” I am always ill if I ingest them. The label gives no warning whatsoever that the glucose syrup comes from wheat, so you can’t avoid it until it makes you ill. You only know after it makes you ill, and ring them. I assume all batches of the glucose they use have levels are below the 20ppm level required, although due to the concentration of glucose in the lucazade, I wonder if the amount being ingested is more of an issue. i.e. “parts per amount consumed” is a better guide.

    It doesn’t label “glucose (from wheat)” because the law is set for the majority not the minority, and therefore because they don’t have to state where it is from, they don’t. They test at 20ppm or less and get the certificate for that product. Once they have got their certificate being less than 20ppm, who is checking the next batches are the same? No one unless you report a suspected false claim to trading standards it seems. The assumption again is that processing removes the gluten, which if you are a biological test system sensitive at this level I me, it is clear the assumption is wrong!

    Not so long ago 200ppm was the level set. Research looks for physical damage to vili that is observable or detectable using currently available methods. I understand damage to vili occurs around 50ppm for most. Research that is sighted in the counter argument, doesn’t always look at an antibody reaction, or more subtle elements of the autoimmune response necessarily.
    So at the moment we seem to be at the point of looking for a building that has already burnt down, (destroyed vili), to define that the level is “correct”. So long as “the majority” of people are OK with 20ppm that is how they set it. And that level was set as a compromise between the current science and the commercial bodies it affects.


    Cross contamination would result in a lot of currently “gluten free” (at 20ppm) foods loosing the gluten free status, so the anti campaign had stiff opposition from industry. So is money in part setting the level?

    The Coeliac society only goes by current scientific understanding, so don’t expect any assistance pushing the boundaries of improvement there!


    They don’t want people who don’t need to avoid food around the 20ppm level to “avoid it unnecessarily if they don’t have to”, thereby further restricting their diet, and “not everyone understands the labels as well as others.”

    Qu. Do you set the height of a door for the average person, so half the people bang their heads, or as far as practicable set it for the tallest?

    This is the same as setting the level at 20ppm, it just that they have currently got the level too high for you and me.


    Because using the building analogy, a fireman who suspects houses is on fire by looking for cold ashes, has already missed the fire. I considered destroyed vili to be way too late to see if I am affected!

    Should the 20ppm be reduced IMO? Yes. However, whilst science (and courage) catch up, an interim step would be to legal require ingredients derived from wheat, barley, etc to be clearly stated, in brackets within the ingredients list. They don’t do it currently for fear of losing sales.
    You may chose to eat foods labelled in such a way if you know you don’t react, so long as it is labelled gluten free, if you know 20ppm is fine for you. If you know you usually react to a “20ppm gluten free” product containing wheat derived ingredients, you would have the right and ability not to eat something you then knew will affect your health.

    Do I have the right to avoid eating something that I know will adversely affect my health? Not currently is seems, because I am not given the information that gives me that freedom of choice.

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

    […] based on the fact that 20 ppm is the most reliable industry standard for testing (you can see my diatribe on 20 ppm being too high here). But by the FDA’s own findings, 20 ppm is too high for people that are “highly […]

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  2. Rice Dream Gluten Free? Hum…. : || : Gluten-Free Gluten - 09/25/2011

    […] So I searched and crawled and emailed the manufacturer (several times) … And found out that while there are no gluten ingredients IN Rice Dream rice milk, they actually use a barely enzyme to manufacture Rice Dream Rice Milk. The manufacturer, Hain Celestial, says that the enzyme is subsequently removed in the manufacturing process and discarded after it’s use. They state that this renders the remaining product Gluten Free. But perhaps this is why I react as though I’m ingesting gluten: perhaps there are trace amounts of gluten left in Rice Dream Rice Milk! Hain states that they test all products labeled as “gluten-free” to ensure they contain less than 10 parts per million, which is below the international standards of 20 parts per million. Which is great, but what if I react to less than 10 PPM? But that’s a subject of another post…. […]

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