Defining “Gluten-Free”: What’s the Deal at FDA?

February 15, 2011 at 1:08 pm 4 comments

When I think back over the past 6 years in the celiac community, there are highs and lows.

The highs: We have seen great improvement in the variety and availability of gluten-free foods.  We can walk into our local supermarket and readily purchase gluten-free foods.  Gluten-free has been named the 8th largest food trend for 2011, an increase from its No. 9 position in 2010.

Now for the lows: The Food & Drug Administration (FDA) has not established a standard to define the term “gluten-free,” so there’s always that bit of doubt about the safety of our food. But, let’s not get discouraged.

Let’s review a little history of allergy and food labeling. In 2002, the Food Standards Australia/New Zealand announced that “all food labels will show the declarations of the presence of potential allergens in foods, such as gluten, peanuts and other nuts, seafood, milk, wheat, eggs and soybeans. In addition, all foods containing genetically modified materials must be labeled as such.”

French Meadow Gluten-Free Products

Clear gluten-free labeling can help us feel confident about the foods we choose.

In 2005, the European Union required manufacturers to identify 12 common food allergens including: celery, dairy, eggs, fish, gluten, mustard, peanuts, sesame seeds, shellfish, soy, tree nuts and wheat, and their derivatives.

On Jan. 1, 2006, the U.S. Food Allergen Labeling and Consumer Protection Act (FALCPA) went into effect. As a result, the presence of eight allergens including dairy, eggs, fish, peanuts, shellfish, soy, tree nuts and wheat are now declared on ingredient lists.

Since the inception of FALCPA, the FDA has been developing a definition for the term “gluten-free,” as there is currently no approved legislation for U.S. food manufacturers or consumers.  Once approved, labeling regulations will help U.S. consumers maintain a gluten-free diet by clearly designating which items are safe to eat, without confusion over potential cross-contamination. “As ordered by the FALCPA, a final rule on this definition was to be enacted by August 2008.”

So how’s the progress going?

On Jan. 23, 2007, the FDA published a proposed rule about defining the term “gluten-free.” The proposed rule included a 90-day public comment period, which ended on April 23, 2007. In addition to public comments, the proposed rule called for a safety assessment related to gluten exposure in individuals with celiac disease, which would help guide the development of a definition for “gluten-free.”

Fast forward to today. It’s more than 4 years later and here we sit, still waiting for the final word. The celiac and gluten-free community is frustrated, and rightly so. What is the hold up?   By establishing a U.S. definition for “gluten-free” and uniform conditions for the labeling of foods, the FDA will help ensure that persons purchasing U.S. products have accurate information. Shouldn’t this be a priority?

Fast & Fresh Gluten-Free Mix

What do you think should define "gluten-free"?

Bingo. In the midst of the blizzard that struck Philly a few weeks ago, I received a phone call from Rhonda Kane, MS, RD, Consumer Safety Officer at the FDA. I asked her for the scoop.  Rhonda assured me that the FDA has been working diligently on a safety assessment related to gluten exposure and celiac disease. Once the report is finalized, FDA plans to share the safety assessment with the public and reopen a comment period so individuals can help decide how this assessment will be used in defining “gluten-free.”

So, that’s where we stand.

The public comment period has yet to be reopened, but I’d like to hear some opinions now. Keeping our families safe is top of mind for all celiac sufferers nationwide and worldwide, so let’s make this an ongoing discussion. What do you think should be included in the definition of “gluten-free”?



Entry filed under: Alice. Tags: , , , , , , .

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4 Comments Add your own

  • 1. Glutenista Gluten-Free  |  February 15, 2011 at 1:28 pm

    THANK YOU Alice & the NFCA for continuing to advocate for all of us who must live gluten-free! We cannot tell you how many times we’ve been frustrated by gluten-free labeling (our fave example: a gluten-free label & symbol with “may contain wheat” right under it). Ideally gluten-free labeling would require testing to a certain PPM to ensure safety, but at this point we’ll take any improvement to current regulations 🙂 Please let us know if we can help in any way!

    xoxo, Glutenista… making gluten-free fabulous!

    • 2. K Leach  |  February 15, 2011 at 3:10 pm

      Ah yes…my fave is when a product says “gluten-free” on the front but when you read the fine print on the back of the product it says, “manufactured on the same equipment as wheat”. Are you kidding me? UGH! I know I speak for the entire Celiac community when I say I’m tired of companies jumping on the gluten-free “diet” bandwagon just to make a buck.

  • 3. Food_Paul  |  February 15, 2011 at 2:14 pm

    Hi Alice

    Seems like we are still having the same conversation now we had over brunch before the AFA 2010 event. I think this process is taking way too long and looking at the time line of the events you presented, the FDA should have had this matter all tied up already.

    With the recent amount of legitimate exposure Celiac disease and gluten intolerance has finally gotten (from bloggers such as myself and incredible organizations such as the NFCA as well as in mainstream media), and the amount of product out there that actually is gluten free, tested by the manufactures and labeled safely and visibly for us as consumers, you would think the FDA would sit up and take notice. Maybe even say “gee whiz, the general public and some manufactures think this is important, we should really get a move on here and place labeling standards on food products.”

    I am vested in this for the safety of my family. I think shopping for products should not be the ordeal it is, making us detectives of sorts reading labels a good amount of the time. And proper labeling is not just helping us as the consumer in the stores, it will also help restaurants who say they can cater to you by preparing your food gluten free. However, as talented as they are as cooks, not everyone understands the nature of the beast (gluten) and what names it may hide under. This of course leads to the grief of getting accidentally glutend at a restaurant and the inevitable feeling of uncertainty the next time you want to go out and enjoy yourself.

    Bottom line…move faster FDA !

    Paul Biscione
    Author: loving Food Again
    Writer: Food Living and Everything Else

  • 4. K Leach  |  February 15, 2011 at 3:03 pm

    Obviously it would be extremely helpful if the FDA is ingredient SPECIFIC when publishing their definition of “gluten-free” since there is such a risk for grey area. Possiblly something along the lines of a label stating–DOES NOT CONTAIN: gluten (wheat, barley, rye or cross-contaminated oats) or any derivative or contamination from the listed glutenous sources.


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