USA Gluten-Free Food Ingredients Labels Law 2013 Updates

New USA Gluten-Free Label Rules for 2013 / 2014 —Clear Definition of "Gluten-Free" at 20PPM MAX

When do these new Gluten-Free Labeling Standards Take Effect?

I placed this paragraph before all others because it is very important to make sure you realize that these regulations and standards are NOT immediate — we have just a short one-year wait (unless something changes yet).

We have all been waiting anxiously (many years for many of us) for such standards to come about. And, finally, we have the ruling that becomes effective on September 4, 2013 (although, NOTE: the all-important [gluten-free products labeling] compliance date of this final rule is August 5, 2014).

Finally, Standards for Gluten-Free Products / Ingredients Labels!

This topic of United States gluten-free labeling laws has gotten quite a bit of attention lately now that the US Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA) published their final ruling on the matter in the very detailed 26-page PDF document: 47154 Federal Register/ Vol. 78, No. 150 / Monday, August 5, 2013 / Rules and Regulations — section 21 CFR Part 101 [Docket No. FDA–2005–N–0404] RIN 0910–AG84 Food Labeling; Gluten-Free Labeling of Foods.

I have included the quoted summary-text of the ruling (see below).  But, feel free to read that ruling in its entirety if you have time... it is interesting, and seems to really make a good attempt at preventing GF product manufacturers from "gaming the system" by playing with label wording and so forth; such attempts will lead to a product being deemed "misbranded", and presumably enforcement action will ensue quickly to minimize our risk of exposure to gluten.

What Counts as Truly "Gluten-Free" under new Standards?

Thankfully, the HHS / FDA ruling has made this about as simple as possible for everyone with Celiac Disease.  In short, a product labeled as "gluten-free" MUST test at less than 20 parts-per-million (20ppm / 20 ppm)!  That is really about it.  And, this of course means that, in practice, there can be essentially zero traces of grains like wheat, rye, barley and hybridized / derivative / related grains like spelt, kamut, triticale, and so forth in your foods, or that 20ppm would be exceeded for sure.

20 ppm means that you cannot have over 20milligrams of gluten per kilogram of food. Keep in mind that a milligram is 1/1000th (a thousandth!) of a gram, and a gram is approximately what a small paper-clip weighs —  so this is saying that a full kilogram of food (2.2 pounds of food) cannot contain more than 1/50th-of-a-small-paperclip's weight in gluten within in!  That is a rather small amount (chop a small paperclip into 50 pieces to see) across a rather large pile of food (eating a kilogram of food at once is quite a bit, unless it is nearly all liquid).

What About "Gluten-Free" Oats?

The HHS / FDA made gluten-free oats an acceptable gluten-free product label using the same standards: i.e., oats labeled as "gluten-free" MUST test at less than 20 ppm gluten in order to be considered gluten-free.  Again, simple.  You don't have to eat the GF oats if you still feel unsafe doing so, but at least you will know how much gluten is in such "gluten-free" oats if you choose to consume them  — the same percentage of gluten as any other "gluten-free" labeled diet products.

The Ruling: HHS / FDA Summary Text

Quoted from that PDF:

SUMMARY: The Food and Drug Administration (FDA or we) is issuing a final rule to define the term ‘‘gluten- free’’ for voluntary use in the labeling of foods. The final rule defines the term ‘‘gluten-free’’ to mean that the food bearing the claim does not contain an ingredient that is a gluten-containing grain (e.g., spelt wheat); an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or an ingredient that is derived from a gluten- containing grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food (i.e., 20 milligrams (mg) or more gluten per kilogram (kg) of food); or inherently does not contain gluten; and that any unavoidable presence of gluten in the food is below 20 ppm gluten (i.e., below 20 mg gluten per kg of food). A food that bears the claim ‘‘no gluten,’’ ‘‘free of gluten,’’ or ‘‘without gluten’’ in its labeling and fails to meet the requirements for a ‘‘gluten-free’’ claim will be deemed to be misbranded. In addition, a food whose labeling includes the term ‘‘wheat’’ in the ingredient list or in a separate ‘‘Contains wheat’’ statement as required by a section of the Federal Food, Drug, and Cosmetic Act (the FD&C Act) and also bears the claim ‘‘gluten-free’’ will be deemed to be misbranded unless its labeling also bears additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a ‘‘gluten-free’’ claim. Establishing a definition of the term ‘‘gluten-free’’ and uniform conditions for its use in food labeling will help ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. We are issuing the final rule under the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). 

DATES: Effective date: The final rule becomes effective on September 4, 2013. Compliance date: The compliance date of this final rule is August 5, 2014. See section II.B.4 (comment 35 and response 35) for an additional explanation of the compliance date and implementation of this final rule.

Continue to read this Gluten-Free Blog for all sorts of gluten-free recipes, product-reviews, and related information. In addition, visit my Gluten-Free Recipes Site where many of the recipes I have featured on this blog are available.

Celiac Disease & Cancer Risk (Lymphoma) : New Study Confirms Increased Risk

Lymphoma Risk Elevated in Persons with Celiac Disease

Latest Scientific Study Confirms Elevated Risk

I was just reading newly released study findings about Celiac Disease and an associated risk of Lymphoma (a type of blood cancer) and lymphoproliferative malignancy.  Headlines like this are always concerning for those of us facing a lifetime with Celiac Disease and this one definitely gave me further incentive to do everything in my power to maintain a 100% gluten-free diet.  In summary, as quoted from the article:

"Patients with celiac disease have an elevated risk for lymphoproliferative malignancies, particularly if they have persistent villous atrophy, a population-based cohort study found."

Well, that sure does not sound very cool!  And, it is a bit frightening to see the words lymphoma / cancer associated with Celiac Disease.  I have seen other associations in the past, but this latest study really made clear the raw risk "multiplier" that we CD persons face vs. the "average population" or whatever.

You have Celiac Disease. Should you be concerned?

A key phrase to pay special attention to in that quote is: "...particularly if they have persistent villous atrophy".  Persistent villous atrophy is the state your intestinal villi are much more likely to be in if you do not adhere to a permanent strict 100% gluten-free diet.

Say no more: I will do everything possible to avoid getting gluten in my diet. Heck, I was already "paranoid" (by some accounts), and now I am probably going to be ever more extreme in my caution.  As best as is possible and within my control, it seems foolish for me not to try to maintain 100%-GF status when there are substantial consequences for not doing so.

The numbers (from the study) now:  basically, your risk of lymphoma (as a person with Celiac Disease) is going to be a full FIFTY PERCENT HIGHER (+50%) than the celiac-disease cohort mean-value IF you present with persistent villous atrophy over a long period (in this study, 9 years was the period discussed in the following quote), as would be much more likely if you do not remain 100% "clean" (i.e., strict gluten-free diet):

"During a median follow-up time of 9 years after the second biopsy, 53 patients (0.7%) were diagnosed with a lymphoproliferative malignancy. The incidence in the overall group was 67.9 per 100,000 patient-years. 

In contrast, the incidence in those with ongoing villous atrophy was 102.4 per 100,000, the researchers reported."

I arrived at the "FIFTY PERCENT" figure through simply math (102 / 68 = 1.5, or, 50% greater).  I consider that a substantial and noteworthy increase in risk.

But, the study did not even stop there, as they went on to assign "hazard ratios" to more detailed sub-groups within the study population, and at specific times within the study (e.g., 12 months after second biopsy still showing atrophy).  Basically, the hazard-ratio is the increased likelihood, expressed as a multiplier, of something happening that you don't want to happen.  Some very specific hazard-ratios went rather high (up to NINE+ TIMES the baseline rate), as stated in these quotes:

"Among these patients with persistent villous atrophy, the higher risk was most prominent during the first 12 months after the follow-up biopsy, with a hazard ratio of 3.67 (95% CI 0.80-16.86), decreasing to 1.99 (95% CI 0.79-4.97) after 5 years.

[...]

An additional factor that was associated with greater risk was biopsy evidence of total or subtotal villous atrophy (HR 3.96, 95% CI 1.65-9.50), which was particularly pronounced in patients with T-cell lymphoma, who had nine times the risk (HR 9.23, 95% CI 1.66-51.34)."

And, basically the takeaway I am getting from all this is that, yes, if you have CD and present with persistent villous atrophy, you should be somewhat concerned.  First of all, you have to consider whether you are doing everything in your power to maintain a truly "clean" diet (gluten-free diet), since that is first and foremost the best thing you can do to minimize the villi issues.

Hopefully we can all manage to minimize mucosal damage (and especially persistent damage) to our intestinal villi through a strict gluten-free diet!  Yes, some of us will face a very difficult  time recovering from exposure to gluten (especially since it is so darn difficult to avoid the occasional accidental cross-contamination and so forth), but we must do our utmost to TRY to maintain our strict diets.

Luckily, the Federal USA government is stepping into the scene with regards to gluten-free labeling laws and all (was big news this past week -- which I plan to summarize and blog about soon), as this should help make it easier for us to know (with a higher degree of certainty) what is truly "gluten free" on the store shelves.  But, even with that, there is a lot of vigilance and diligence required on our part to stay GF all the time.

Continue to read this Gluten-Free Blog for all sorts of gluten-free recipes, product-reviews, and related information. In addition, visit my Gluten-Free Recipes Site where many of the recipes I have featured on this blog are available.

Affordable, Quick Celiac Disease Test and Monitoring Method

New Test for Celiac Disease: Faster, Cheaper

"Lab-on-a-Chip" Blood-Analysis Technology Shows Promise

Imagine having an accurate, quick, cost-effective diagnosis and monitoring solution for celiac disease and gluten-sensitivity available. All of you that have endured the current costly and invasive methods of testing for Celiac Disease — like an upper-GI / duodenal endoscopy and biopsy (been there, done that, hated it) — will certainly appreciate how much better testing could be if a simple drop of blood could be analyzed to determine if you have Celiac Disease or are being exposed to, and are reacting adversely to, gluten. The thought of being able to simply place a drop of blood on a sensor, either at a doctor's office or perhaps even at home, sure sounds like a fantastic alternative to me!

A promising new technique for analysis and detection of Celiac Disease got my attention when I just read about it. If things progress as expected, we could see a test within the next couple years that is no worse than pricking your finger and placing a drop of blood on a sensor (sort of like what people monitoring their blood sugar for diabetes do regularly). Words alone can hardly express how much better this sounds than endoscopes and biopsies!

The new "CD-MEDICS" (Celiac Disease Management Monitoring and Diagnosis using Biosensors and an Integrated Chip System) project being undertaken by a consortium of 20 partners with substantial funding from the European Commission has created a system using a combination of technologies from microfluidics, nanotechnology and genetic testing to produce what is in effect a "lab on a chip" technology that will offer a quick, low-cost and highly accurate test for Celiac disease.

Imagine having INSTANT ACCURATE RESULTS Available!

This new CD-MEDICS approach offers the incredible advantage of instant diagnosis. A disposable lab-on-a-chip (the whole "chip" looking about like a credit-card in size), upon which a drop of blood has been applied, is placed into a biomedical interface instrument and analysis of the blood sample is carried out in a matter of minutes. Results can then be immediately output to the hospital information system and added to the patient's electronic health record — can you imagine?

Let's contrast this with the current incredibly slow, potentially invasive, costly, and often incorrect or overlooked diagnosis of Celiac Disease... as the article I read states:

The condition [Celiac Disease] is thought to affect one in a hundred genetically predisposed individuals, but many sufferers may be unaware of the causes of their health problems: the average delay from onset of symptoms to diagnosis is almost 12 years. And, if they seek medical attention, there is a high risk of misdiagnosis: for every case of Celiac disease that is correctly identified it is thought that there are seven more that are undiagnosed or misdiagnosed [i.e., ONLY ONE IN EIGHT cases are diagnosed properly now!].

You may be wondering how this new approach can replace other tests and be accurate. Well, it combines DNA testing along with testing for gluten-antibodies in your blood:

'For the first time, we have two microsystems of completely different functionalities -- one for DNA typing and the other for the detection of antibodies -- and we have designed these microsystems to have a common interface with the instrument so that only one instrument with one slot is required for both microsystems,' Prof O'Sullivan says. 'For diagnosing Celiac patients two tests are necessary as DNA testing -- specifically for variants of the HLA gene associated with the disease -- or testing for gluten antibodies alone can return false positives. Testing for both means the results are much more accurate.'

Perhaps even more interesting is how this approach can be used to test for gluten-free diet compliance and exposure to gluten:

Follow up tests to monitor the patient's response to treatment can be carried out in the same way using only the microsystem to detect gluten antibodies.

How much will it cost? When will it be available?

Current DNA testing is expensive, and invasive testing is ridiculously cost-prohibitive. That is where this new testing method really shows promise. How about $25! Yes, only twenty-five bucks — if we (here in the USA) can ultimately get the test for the 20-Euro price equivalent that is projected for European markets. Of course we are the only major developed country without any universal national healthcare program, so it will not surprise me if that $25 turns into $100++ here! But, I guess we will have to wait and find out.

Perhaps I can make a new business of purchasing a testing device (expected to cost around $8,000 USD) and a bunch of these "labs-on-a-chip" and specialize in just giving people Celiac Disease testing and gluten-free-diet compliance monitoring? It sure would be nice if something like that was available to drive down cost and make this available to a wide range of people. I'd be a my own first customer; I am curious to see how my diet-compliance is, especially in case I am accidentally being exposed to gluten somewhere I do not know about.

This system and process is currently being tested in Slovenia and is expected to be widely available in the next 2 or 3 years if all goes well. For validation, testing of a few hundred patients is underway and involves comparing the results of Celiac tests using this new system with those from analyzed tissue biopsy samples (i.e., results from traditional invasive approach). If you want to read the entire article that I did, see this link.

Continue to read this Gluten-Free Blog for all sorts of gluten-free recipes, product-reviews, and related information. In addition, visit my Gluten-Free Recipes Site where many of the recipes I have featured on this blog are available

Controlling Blood-Sugar / Diabetes

Exercise and Blood Sugar Impact

I was just reading the results of a new 6-month study showing the impact of exercise on blood-glucose levels, and in particular how the combination of weightlifting (i.e., resistance training) and aerobic exercise yield a rather impressive reduction in Glycosolated Hemoglobin (aka HbA1c) readings. Given recent news of near-epidemic proportions of Americans that have, or will develop, type 2 diabetes (non insulin-dependent diabetes) in their lifetimes (nearly one in three persons!), it sure seems like there needs to be an overall wakeup call issued to stress the importance of exercise and how it can prevent this insidious condition.

For those of you new to HbA1c plasma-glucose-concentration test readings, they are represented as a percentage — and in healthy persons with normal blood-sugar, the reading will be roughly between 4% and 5.9%, and readings above 6.5% (or 7% depending on source) are considered indicative of Type 2 diabetes. And, "controls" in a study are like placebos — in this study they represent sedentary individuals.

With that in mind, here are some of the details (quite impressive for just 6-months of exercise) which include:

• A 0.51 percentage point HbA1c reduction in the aerobic exercise group versus controls
• A 0.38 percentage point HbA1c reduction in the resistance training [with weights] group compared with controls
• An additional 0.46 percentage point HbA1c reduction in the combined exercise group compared with aerobic training alone
• An additional 0.59 percentage point HbA1c reduction in the combined exercise group compared with resistance training alone
• I.e., patients who did both aerobic and resistance regimens more than doubled the benefit with a drop in HbA1c of 0.9 percentage points!

So, what does .9% change in your HbA1c percentage value mean? Well, let's say you currently have a glycated hemoglobin (HbA1c) of 6.0 currently (i.e., essentially "pre-diabetic" status), which equates to an average blood-sugar of 120mg/dL, and you were able to drop to a 5.0% reading, you would now have an average blood-sugar of around 80 — meaning, a 1% drop in average blood-glucose from exercise could move you from being on the fringe of diabetes to being squarely within normal / healthy numbers.

Start Exercising Now and Reduce your Blood Sugar Levels

It's time to make exercise a part of your life if it isn't already. If you are living on a gluten-free diet already, you have demonstrated your ability to adhere to a lifestyle change that takes work and perseverance. You obviously have the resolve to take up and maintain a healthy exercise program — in fact, this should be rather easy compared to completely removing gluten from your diet! This study achieved its results through 45-minute/day exercise, with aerobic activity performed 3 times per week and weights/resistance-training another 3 days (for the combined maximum benefit to reduced blood sugar levels). It sounds like a lot, but it sure sounds better than a future filled with the risks and complications associated with high blood sugar (including heart disease, hypertension, vision loss, kidney damage, depression, and much more).

This study on exercise and blood-sugar control is particular to persons with Type 2 diabetes. When talking about Type 1 diabetes (insulin dependent), the exercise portion of the equation gets more difficult, as it can cause substantial swings in blood sugar that can be difficult to manage. Although Type 2 diabetes is no more prevalent among persons with Celiac Disease than the normal population, Type 1 diabetes risk is strongly correlated with Coeliac / Celiac Disease (aka Gluten Allergy, Gluten enteropathy, gluten-intolerance, etc) among adolescents — the risk is extremely high in fact, and another study [which was on Medscape at the time of this writing but whose link was no longer valid] concluded that: Celiac Disease Triples the risk of Type 1 diabetes in children.

This new exercise study is fantastic information, and further validates how important an exercise regimen is to controlling blood-sugar and avoiding Type II diabetes (not to mention the other health benefits). And, whether you have Type 2 diabetes, pre-diabetes, or have normal blood sugar readings, everyone should consider some sort of exercise to make sure they don't allow their blood sugar to increase further over time. I do as I say, and I regularly exercise in an attempt to ensure optimal long-term health — now with even more scientific reinforcement of my actions. I'm hoping others can benefit from this as well.

Continue to read this Gluten-Free Blog for all sorts of gluten-free recipes, product-reviews, and related information. In addition, visit my Gluten-Free Recipes Site where many of the recipes I have featured on this blog are available.