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Researcher says proposed gluten-free standards are sound - Florida Times-Union (blog)


Scott Adams

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Florida Times-Union (blog)

When you're diagnosed with celiac disease, the first thing you're told is that you have to eliminate gluten from your diet. Basically, if you have celiac, the gluten found in wheat, rye and barley is attacking your small intestine and the only ...

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LDJofDenver Apprentice

FDA needs all of our feedback:

ppm is only half the battle

the other is what will the FDA allow folks to print on their labels

(should NOT be allowed to state gluten free on front product label, IMHO, if says 'processed in facility that also processes wheat' UNLESS there is testing)

Was announced past week that the FDA will await more comments before finalizing regs on gluten free food labeling. Send them your comments!

One last chance to let them know your experience and what needs to be done to protect people with Celiac Disease.

I submitted comment that if it were peanuts, 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"! Why should that be different with 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? If they want to advertise gluten free, they should be required to test for it to ensure that it is.

How to contact:

The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.

To submit your comments electronically to the docket go to www.regulations.gov

1. Choose “Submit a Comment” from the top task bar

2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space

3. Select “Search”

To submit your comments to the docket by mail, use the following address:

The Division of Dockets Management

HFA-305

Food and Drug Administration

5630 Fishers Lane, Room 1061

Rockville, MD 20852

Include docket number FDA-2005-N-0404 on each page of your written comments.

Skylark Collaborator

I wrote to tell them that 20 ppm foods make me sick. Hardly anyone on the board can eat Amy's, for a 20 ppm example. I prefer GFCO foods too, and I told the FDA that.

There is another "gotcha" in the FDA proposal. They want to only allow foods that wouldn't normally be gluten-free to be labeled as such. Sort of like how it's illegal to label a banana "fat free" since bananas are always fat free. The problem is that Tricia Thompson's study showed CC over 20 ppm in samples of flours from naturally gluten-free grains like millet and buckwheat. How can we ever buy safe baking supplies if it's illegal to test flours and label them gluten-free?

Takala Enthusiast

20 ppm - the "low gluten" $%^&*(*())@+!!! bull pucky manure.

The Mark Basch, gluten glutton (name of blog) writer at the Jacksonville.com link has not been gluten free that long, (since Dec 2010) and hasn't been writing about it that long, and I don't think he's cooked gluten free that much yet, so we get dismissive, simplistic stuff like this -

Guandalini said that "studies have shown quite conclusively" that all celiacs can safely consume up to 10 mg of gluten per day. That means a celiac would have to ingest more than 1.1 pounds daily of foods that contained the maximum of 20 ppm of gluten to potentially damage the intestine, he said.

He also said while all celiacs can consume 10 mg, the majority can consume up to 50 mg of gluten per day, so the majority could eat up to 5.5 pounds a day of those foods before getting sick.

I do not trust anything coming out of the University of Chicago.

You know, and I know, and most of us who really are celiac or gluten intolerant know, somebody or ourselves that have eaten relatively small quantities of gluten contaminated food, sometimes even labeled to that less than 20ppm, and gotten deathly ill on it.

Just like I would not interview just one person for a point of view on a deep topic regarding food safety for millions of patients, and then say, but sure, it's okay, we can adopt the European standards without researching on whether the Europeans are happy, healthy and well on those standards, because this doctor said so. Author Basch does not even use the word "Codex !"

The FDA News release of 8/2/11 Open Original Shared Link says that they are reopening comments on the 2007 proposal. .

The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as

Takala Enthusiast

Part of the mess:

Open Original Shared Link

FDA proposes in Sec. 101.91(a)(3) to define the claim ``gluten-

free'' to mean that a food bearing the claim in its labeling does not

contain any of the following: (1) An ingredient that is a prohibited

grain; (2) an ingredient that is derived from a prohibited grain and

that has not been processed to remove gluten; (3) an ingredient that is

derived from a prohibited grain and that has been processed to remove

gluten, if the use of that ingredient results in the presence of 20 ppm

or more gluten in the food (i.e., 20 micrograms or more gluten per gram

of food); or (4) 20 ppm or more gluten.

Examples of a prohibited grain include, but are not limited to,

barley, common wheat, durum wheat, einkorn wheat, emmer wheat, kamut,

rye, spelt wheat, and triticale. Examples of ingredients that are

derived from a prohibited grain and that have not been processed to

remove gluten include, but are not limited to:

<bullet> Farina, flour made from any of the proposed prohibited

grains, graham, and semolina;

<bullet> Hydrolyzed wheat protein, vital gluten, wheat bran, and

wheat germ; and

<bullet> Barley malt extract or flavoring and malt vinegar.

Because these ingredients are derived from a prohibited grain and

have not been processed to remove gluten, they are presumed to contain

gluten.

Examples of ingredients that are or are sometimes derived from a

prohibited grain and processed to remove gluten include, but are not

limited to:

<bullet> Food starch--modified (modified food starch); and

<bullet> Wheat starch.

Although these ingredients have been processed to remove gluten,

FDA recognizes that there may be different methods of deriving these

ingredients, and that some methods may remove less gluten than others.

Therefore, FDA proposes to prohibit a food that contains one of these

ingredients from bearing a gluten-free labeling claim if the use of the

ingredient results in the presence of 20 ppm or more gluten in the

food.

there is more at the link

Takala Enthusiast

And then there is this, from the same page:

Open Original Shared Link

FDA is not proposing to include oats in the definition of a

prohibited grain. As discussed in section I.C.3 of this document, the

unconditional exclusion of oats from the diet of individuals with

celiac disease is not supported by the National Institutes of Health

Conference Development Conference Statement on Celiac Disease (Ref. 1)

or by the American Dietetic Association (Ref. 58). FDA recognizes that

a small percentage of individuals with celiac disease may not be able

to tolerate some of the proteins that naturally occur in oats. However,

it appears that a great majority of individuals with celiac disease can

tolerate a daily intake of a limited amount (e.g., 50 grams) of oats

that are free of gluten from wheat, rye, barley or their crossbred

hybrids. Oats are reported to add variety, taste, satiety, dietary

fiber, and other essential nutrients to the diet of individuals with

celiac disease; thereby making their diet more nutritious and appealing

(Refs. 44, 51, 56, and 71). Inclusion of oats in the diet of

individuals with celiac disease who can tolerate oats may therefore

result in the improved nutritional and health status of those

individuals (Refs. 55 and 71).

According to comments FDA received in response to its August 2005

public meeting on gluten-free labeling, at least two food manufacturers

can produce

[[Page 2802]]

oats that do not contain gluten from wheat, rye, barley, or any of

their cross-bred hybrids. Allowing such oats to bear a gluten-free

labeling claim would make them easier to identify and perhaps would

encourage other manufacturers to produce such oats. Conversely,

including oats in the definition of prohibited grain could eliminate

any incentive for manufacturers to produce oats free of gluten from

other grains because those manufacturers would have no way of

distinguishing their products in the marketplace. FDA requests comments

on whether the agency should include oats in the definition of a

prohibited grain.

Yee gads. How do I tell them let the manufacturers continue to make the gluten free tested and labeled oats for those who want them, but leave the stuff OUT of the regular category of gluten free foods so it is not showing up unannounced in things like gluten free chips, bread, cakes, and bagels ?

If the great majority of celiac people aren't diagnosed yet, how can they keep making this claim that the "gluten free" oats work for the majority ?

Skylark Collaborator

If the great majority of celiac people aren't diagnosed yet, how can they keep making this claim that the "gluten free" oats work for the majority ?

I might start a poll on the board becasue I'm curious. I have the sense that a lot of us do tolerate oats. I certainly do.

The rest of it is maddening. I've already gone and said my piece. I would encourage EVERYONE on the board to write. Read the legislation and make sure you address anything in it that would be a problem for you when you pick up a box of "gluten-free" food under the new regulations.


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    • trents
      @BlessedinBoston, it is possible that in Canada the product in question is formulated differently than in the USA or at least processed in in a facility that precludes cross contamination. I assume from your user name that you are in the USA. And it is also possible that the product meets the FDA requirement of not more than 20ppm of gluten but you are a super sensitive celiac for whom that standard is insufficient. 
    • BlessedinBoston
      No,Lindt is not gluten free no matter what they say on their website. I found out the hard way when I was newly diagnosed in 2000. At that time the Lindt truffles were just becoming popular and were only sold in small specialty shops at the mall. You couldn't buy them in any stores like today and I was obsessed with them 😁. Took me a while to get around to checking them and was heartbroken when I saw they were absolutely not gluten free 😔. Felt the same when I realized Twizzlers weren't either. Took me a while to get my diet on order after being diagnosed. I was diagnosed with small bowel non Hodgkins lymphoma at the same time. So it was a very stressful time to say the least. Hope this helps 😁.
    • knitty kitty
      @Jmartes71, I understand your frustration and anger.  I've been in a similar situation where no doctor took me seriously, accused me of making things up, and eventually sent me home to suffer alone.   My doctors did not recognize nutritional deficiencies.  Doctors are trained in medical learning institutions that are funded by pharmaceutical companies.  They are taught which medications cover up which symptoms.  Doctors are required to take twenty  hours of nutritional education in seven years of medical training.  (They can earn nine hours in Nutrition by taking a three day weekend seminar.)  They are taught nutritional deficiencies are passe' and don't happen in our well fed Western society any more.  In Celiac Disease, the autoimmune response and inflammation affects the absorption of ALL the essential vitamins and minerals.  Correcting nutritional deficiencies caused by malabsorption is essential!  I begged my doctor to check my Vitamin D level, which he did only after making sure my insurance would cover it.  When my Vitamin D came back extremely low, my doctor was very surprised, but refused to test for further nutritional deficiencies because he "couldn't make money prescribing vitamins.". I believe it was beyond his knowledge, so he blamed me for making stuff up, and stormed out of the exam room.  I had studied Nutrition before earning a degree in Microbiology.  I switched because I was curious what vitamins from our food were doing in our bodies.  Vitamins are substances that our bodies cannot manufacture, so we must ingest them every day.  Without them, our bodies cannot manufacture life sustaining enzymes and we sicken and die.   At home alone, I could feel myself dying.  It's an unnerving feeling, to say the least, and, so, with nothing left to lose, I relied in my education in nutrition.  My symptoms of Thiamine deficiency were the worst, so I began taking high dose Thiamine.  I had health improvement within an hour.  It was magical.  I continued taking high dose thiamine with a B Complex, magnesium. and other essential nutrients.  The health improvements continued for months.  High doses of thiamine are required to correct a thiamine deficiency because thiamine affects every cell and mitochondria in our bodies.    A twenty percent increase in dietary thiamine causes an eighty percent increase in brain function.  The cerebellum of the brain is most affected.  The cerebellum controls things we don't have to consciously have to think about, like digestion, balance, breathing, blood pressure, heart rate, hormone regulation, and many more.  Thiamine is absorbed from the digestive tract and sent to the most important organs like the brain and the heart.  This leaves the digestive tract depleted of Thiamine and symptoms of Gastrointestinal Beriberi, a thiamine deficiency localized in the digestive system, begin to appear.  Symptoms of Gastrointestinal Beriberi include anxiety, depression, chronic fatigue, headaches, Gerd, acid reflux, gas, slow stomach emptying, gastroparesis, bloating, diarrhea and/or constipation, incontinence, abdominal pain, IBS,  SIBO, POTS, high blood pressure, heart rate changes like tachycardia, difficulty swallowing, Barrett's Esophagus, peripheral neuropathy, and more. Doctors are only taught about thiamine deficiency in alcoholism and look for the classic triad of symptoms (changes in gait, mental function, and nystagmus) but fail to realize that gastrointestinal symptoms can precede these symptoms by months.  All three classic triad of symptoms only appear in fifteen percent of patients, with most patients being diagnosed with thiamine deficiency post mortem.  I had all three but swore I didn't drink, so I was dismissed as "crazy" and sent home to die basically.   Yes, I understand how frustrating no answers from doctors can be.  I took OTC Thiamine Hydrochloride, and later thiamine in the forms TTFD (tetrahydrofurfuryl disulfide) and Benfotiamine to correct my thiamine deficiency.  I also took magnesium, needed by thiamine to make those life sustaining enzymes.  Thiamine interacts with each of the other B vitamins, so the other B vitamins must be supplemented as well.  Thiamine is safe and nontoxic even in high doses.   A doctor can administer high dose thiamine by IV along with the other B vitamins.  Again, Thiamine is safe and nontoxic even in high doses.  Thiamine should be given if only to rule Gastrointestinal Beriberi out as a cause of your symptoms.  If no improvement, no harm is done. Share the following link with your doctors.  Section Three is especially informative.  They need to be expand their knowledge about Thiamine and nutrition in Celiac Disease.  Ask for an Erythrocyte Transketolace Activity test for thiamine deficiency.  This test is more reliable than a blood test. Thiamine, gastrointestinal beriberi and acetylcholine signaling.  https://pmc.ncbi.nlm.nih.gov/articles/PMC12014454/ Best wishes!
    • Jmartes71
      I have been diagnosed with celiac in 1994, in remission not eating wheat and other foods not to consume  my household eats wheat.I have diagnosed sibo, hernia ibs, high blood pressure, menopause, chronic fatigue just to name a few oh yes and Barrett's esophagus which i forgot, I currently have bumps in back of my throat, one Dr stated we all have bumps in the back of our throat.Im in pain.Standford specialist really dismissed me and now im really in limbo and trying to get properly cared for.I found a new gi and new pcp but its still a mess and medical is making it look like im a disability chaser when Im actively not well I look and feel horrible and its adding anxiety and depression more so.Im angery my condition is affecting me and its being down played 
    • marion wheaton
      Wondering if anyone knows whether Lindt chocolate balls are gluten free. The Lindt Canadian website says yes but the Lindt USA website says no. The information is a bit confusing.
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