The FDA Gets Serious About Gluten-Free Labeling Laws

Photo by Charles Votaw (c.votaw@verizon.net)

Nearly three years past the 2008 deadline, the FDA is finally getting serious about defining what “gluten-free” means on food labels. Today, without a standard by the FDA, there is no legal requirement that needs to be met for a manufacturer to label food “gluten-free.” This has led to confusion for consumers and considerable angst for the 1 in 133 of them that suffer from celiac disease.

Gluten is found in wheat, rye, barley, and hybrids of these grains. Those who suffer from celiac disease, an autoimmune disorder, cannot absorb the gluten found in these grains, resulting in damage to the intestines.

With 10000 signatures on a petition that accompanied the building of the world’s largest gluten-free cake at a recent gluten-free labeling summit in Washington, the voices are now loud enough for Congress to take action. On August 3rd, the FDA re-opened the comment period for a proposed gluten-free labeling law.

Andrea Levario, the Executive Director of the American Celiac Disease Alliance (ACDA) spoke to Jules Dowler Shepard, one of the leaders of the 1 in 133 movement, in a web interview on August 4th. Levario noted that there was complexity in implementing gluten-free labeling laws – an acceptable threshold of gluten needed to be determined – making it trickier than the labeling of food allergens. A safety assessment needed to be completed.

That safety assessment has concluded that, based on the scientific evidence available today, 20 parts per million (ppm) of gluten is a safe level for those with celiac disease, supporting the proposed law.

Key points of the proposed legislation (re: Docket ID: FDA-2005-N-0404) include:

• A product may be labeled “gluten-free” only if it is at or below the defined threshold of 20 ppm, a number that is generally accepted by experts as safe for those with celiac disease.
• Products that are inherently free of gluten (e.g. non-grain products) will be in violation of the law if they are labeled “gluten-free."
• The labeling will be voluntary. The lack of a statement on gluten will not mean that there is no gluten in the product.

Levario hopes to see the standard out by the third quarter of 2012. It is expected that there will be a lag time set for products to conform. The comment period is open until October 3rd.

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