Treatment Guide

FDA Gluten Free Labeling Update

Cheryl Harris Gluten Free Works

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!

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 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.

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 (, 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. 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.

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.

Author Information: Cheryl Harris, MPH, RD, LD, Alexandria, VA, USA.
Cheryl Harris, MPH, RD, LD, Registered Dietitian and Nutritionist.  Her passion is teaching people to live and love a gluten-free diet in the Northern Virginia area. For more, or follow on Twitter @cherylharrisrd

About Cheryl Harris, MPH, RD, LD

Cheryl Harris, MPH, RD, LD, Registered Dietitian and Nutritionist. Her passion is teaching people to live and love a gluten-free diet in the Northern Virginia area. For more, see or follow on Twitter @cherylharrisrd


  1. 20ppm is too high for me – I go for zero if at all possible, even avoiding the ‘made in a factory that also handles wheat’. And yes, plase have it on medications – so many have wheat or derivatives and lactose in them and it is very arduous checking with manufacturers who don’t always reply.

  2. I don’t agree it should be 20ppm. If most good GF products are already being made and consumed safely around 3-5 ppm, then the labeling should require that, less than 6ppm. (Just like Estrella Daura GF beer from Spain.)
    I also don’t think our FDA should look to European standards, since the wheat over there (at least in places where wheat originated) is not the bastard, convoluted, modified grain that it has become over here.
    I also think that something needs to be done about restaurants and farmers market vendors advertising GF food. They need to be regulated! We need to know they have had GREAT training or similar. There needs to be a sticker or certification they can display.

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