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G-Free Labeling Part II Sept Newsletter

Posted Sep 07 2011 8:39pm

Gluten Free Labeling

The FDA is finally moving on regulating the claim “gluten-free” on packages, which is fantastic news!  Lots of people have put in countless hours to make this happen.  We’ve got 1 month left to comment—until October 3rd—and YOUR comment is vital to getting the law YOU want.

During the Aug 2nd teleconference, we heard that the comment period was re-opened and we might have a law by late 2012.  Several prominent researchers, including Dr. Alesso Fasano and Dr.Stefano Guandalini , spoke in favor of the new proposed legislation. “This is a standard that has been in use in Europe for almost two decades, & the science supports the U.S. adopting it as well,” commented Dr. Fasano.  I posted highlights of the teleconference , but upon reading the 90+ page safety assessment , I had a lot of questions! http://1.usa.gov/r4NDLA

The safety assessment suggests that for the most sensitive Celiac, ONE ppm would be the safest standard, as opposed to the proposed 20 ppm. “In sum, these findings indicate that less than 1 ppm level of gluten in foods is the level of exposure for individuals with CD on a GFD that protects the most sensitive individuals with CD and thus protects the greatest number of individuals with CD from experiencing detrimental health effects from long term exposure.”

Or, in plain English, to err on the side of caution and protect every single Celiac, we’d be looking at 1 ppm or less.  ACDA put out a statement from Dr. Guandalini explaining the gap here http://1in133.org/proposal/resources/assessment/   The explanation was that the 1 ppm adds in a wide—possibly more than 10-fold—margin of error.  Dr. Alessio Fasano also has a nice article, “In defense of 20 PPM” on his website. http://bit.ly/mQLHXy

I think instinctively we all want the standard to be at zero, but first, we can’t get below what machines can detect (general consensus is around 3-5 ppm) and we can’t buy what’s not available on the market. According to the Federal Register:Currently, analytical methods that can reliably and consistently detect gluten at levels lower than 20 ppm do not appear to be available. It may be difficult or infeasible for food manufacturers to meet a lower gluten threshold level or that meeting a lower level could increase their food product costs… fewer and/or more expensive GF-labeled foods would be available to individuals with CD, placing them at higher risk of developing serious health complications from CD…Dr. Guandalini echoed this concern, and implied that our choices were 20 ppm, or “unthinkably low level of gluten, which would evidently result in a dramatic reduction – and perhaps even a disappearance – of available GF products”. 

That doesn’t quite add up.  There are several programs out there which will certify foods at 5 and 10 ppm, such as CSA , GIG and NFCA , so it appears we have the technology.  Also, by every account, the GF marketplace is booming.   Tricia Thompson , trailblazing RD of Gluten Free Watchdog states: “Based on testing done by Gluten Free Watchdog ( www.glutenfreewatchdog.org ), the majority of food is testing below 5 ppm gluten and most of the products testing this low do not carry any specialty certification.”

In other words, it seems like the technology exists and the gluten-free market can handle lower than 20 ppm.  So I really don’t agree that it’s 20 ppm or the risk of not having GF products.

Another, unaddressed reason for concern is the study used to determine 20ppm is based on a total of THIRTEEN people with Celiac disease for 3 months, coupled with the fact that the 20ppm is the standard for Europe.  Extensive studies determining a safe level haven’t been done to date. http://bit.ly/r8kxJY   However, I don’t believe we need to, or should wait around for that to happen for FDA to take action!

Also, while the statements from doctors are very important and useful, in my humble opinion the FDA should be explaining more clearly why they decided not to use their own report to develop the recommendations, and they should be disseminating that info.  This explanation should be made along with the FDA documents, so everyone can easily access it.  I’m a dietitian, but not trained in reading studies on levels of concern and how that translates into real life, and neither is the general public.  I hope they choose to make their decision-making transparent.  There is no proof that 20 ppm is problematic, and there is no proof that 10 (or 5) ppm is safe. However, I hope we can shoot for the most conservative level that still leaves us with enough gluten-free products.  If we can do it, I personally believe we should.

So my comments to the FDA:

  1. Thank you for this movement toward legislation!  We are looking forward to an enforceable, meaningful label of gluten-free products.
  2. A 20 ppm law would protect most people with CD. If that’s the lowest amount possible, I’m all for it. Yet it seems like the technology to measure 10 ppm is available, and that would be my strong preference.
  3. Please incorporate newer research, such as the studies that came out on gluten-free grains and flours and cross contamination .
  4. Please, take this opportunity to define the “made in a factory” statements.
  5. Look closely at the issue of considering oats gluten-free, since there is still a good deal of controversy on the issue.
  6. Please do NOT have the designation “low gluten”, which may confuse people.
  7. It would be fantastic to have gluten labeled on medications, (this is not under the FDA, and they were pretty clear it’s not on the table at this point)

Resources around the web:

How does this change your view of the proposed gluten-free labeling laws?  The FDA says they want to hear from us. Let’s grant their wish. http://1.usa.gov/rd84Ay

Agree?  Disagree? What’s on your wish list?  Whatever your view, I hope everyone who has a vested interest in this legislation takes the time to write into the FDA.

A very big thank you to the FDA for hosting this discussion and taking this next step, and to 1 in 133 , American Celiac Disease Alliance , University of Maryland Center for Celiac Research and many, many others for getting this legislation moving again.  Without them, this discussion wouldn’t be happening.

And, DC Celiacs will have a special guest, Suzanne M. Wolcoff, of the FDA at the quarterly meeting on Sept 10th.  Next Meeting Date: Saturday, September 10, 2011, 2:00–4:00 pm

Meeting Topic: FDA Proposed Regulations for Gluten Free Labeling
Speaker: Suzanne M. Wolcoff, M.S., R.D.
Food Labeling and Standards Staff
Food and Drug Administration

Location: Rockville Library
21 Maryland Avenue, Rockville, MD 20850
www.montgomerycountymd.gov/apps/libraries/branchinfo/ro.asp

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CSA Chapter 100 will have its meeting Sunday, Sept 11th from 3-5. RSVP required!  For more info, contact

CSA/USA Chapter #100 571-289-5675

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Children’s National Medical Center is having a wonderful event, Bite Back at Celiac with a live auction on Saturday, September 24, 2011 to benefit their Celiac Disease program.

Saturday, September 24, 2011
Bethesda North Marriott Hotel & Conference Center
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Tues, September 27 (7:00 – 8:30PM) – What and How to Eat: Exploring Healthier Choices – PART 1 of 6 classes -I will be holding a 6 part program at the Kaplan Center that uses interactive exercises to help participants formulate their own “nutritional wisdom.” The goal will be to discover new ways to eat well (think healthy and delicious). Discussions will include changing the way we eat, which in turn, influences the portion sizes we select and the overall quantity of food we consume. The program is spaced over 12 weeks this fall, beginning on Tuesday, Sept. 27, and ending on Tuesday, Dec. 6. Don’t miss out! You can reserve your seat in this program by calling 703-532-4892 or click here to send us and email expressing your interest in learning more about the program. Please contact us as soon as possible because we are space-limited to 12 participants. Course fee is $195.00/person.

Harris Whole Health offers individual sessions, family sessions and group classes to help people eat healthier and feel better! Whether you are dealing with Celiac Disease, food allergies, picky eaters, children on the Autistic spectrum, chronic illness, or if you just want to feel and look better, Cheryl can help you achieve your goals. For an appointment with Cheryl Harris, Registered Dietitian and Nutritionist, please click here or call 571-271-8742.

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