Will The FDA Finally Implement Standardized Gluten-Free Labeling?

The Food Allergen Labeling and Consumer Protection Act of 2004 mandated that the presence of any of the “eight major allergenic foods” be clearly identified on a label.  This included wheat, milk, soybeans, peanuts, tree nuts, eggs, fish, and crustacean shellfish.  Additionally, the law required the Food and Drug Administration (FDA) to finalize standards for "gluten-free" labeling by August, 2008.  Unfortunately, the regulations have still not been finalized; more than three years later, we are still waiting for FDA to fulfill that mandate and establish the "gluten-free" standard.

But hope was restored on August 2, 2011, when the FDA announced it was reopening the Gluten-Free Labeling proposal for an additional 60 day comment period.  Advocacy organizations such as 1in133.org (so named to represent that an estimated 1 out of every 133 Americans suffers from the disease) implored celiacs to add their names to the petition and share their comments on the proposed gluten-free labeling standard.  At the close of the comment period yesterday, the American Celiac Disease Alliance (ACDA) submitted its comments to the FDA in the form of a nine page document.

Principal among the comments is the ACDA's concurrence with the FDA's proposal that a product may be labeled “gluten-free” if it does not contain 20 parts-per-millon or more of gluten.  Although in theory celiacs must follow a 100% gluten-free diet, which may lead some to believe that a 0 ppm standard is necessary, research has demonstrated that a 20 ppm standard is safe for the majority of individuals with celiac disease.  The proposed rule is very important as there is currently no agreed upon industry standard as to the "acceptable" amount of gluten in a producted deemed gluten-free.

I also believe the inclusion of the following comment (if implemented) represents a great leap forward:

"The ACDA strongly urges the FDA to bar the use of qualifying claims for inherently gluten-free foods and require all products labeled ‘gluten-free’ to be in compliance with the <20ppm standard, and follow the same labeling protocols. Although this position differs from existing policy for the labeling of inherently ‘free’ foods, it is warranted to help maximize the safety of celiac consumers."

Currently, if a product is not labelled "gluten-free", a celiac must analyze the ingredients before making a judgment call as to its safety.  But even products that some would deem "obviously" gluten-free (i.e. oats & other grains as detailed in ACDA comments) can present risks.  Requiring the same labeling standards for these products would make the celiac experience at the grocery store much less taxing.

Now that the FDA has received our comments, we celiacs continue our wait.  Perhaps we should not be overly encouraged, as the organization has already dragged its feet on this issue for a displeasing amount of time.  But sooner or later, the FDA will implement standardized gluten-free labeling, and celiacs everywhere will rejoice in knowing that our interests are finally being recognized.  As always, hope is a good thing.