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

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.”

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?

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”?

-Alice