FDA Gluten-Free Food Labeling Soon to Become Reality

The road to proper gluten-free labeling has been long and filled with bureaucratic hurdles, but the light at the end of the tunnel is finally shining through. It has been over 8 years since the FALCPA (Food Allergen Labeling and Consumer Protection Act) labeling standards went into effect. So long ago, that people ask, “what happened to the gluten-free labeling provisions?”

Progress on that front has been slow in coming. And some of you may not know the steps that it has taken to get to this point, so here’s a quick overview of the gluten-free rule making process. First, FALCPA required the Secretary of Health and Human Services (HHS) to develop a standard for gluten-free labeling and set timeframe for that proposal to be made, August 2006. The Secretary delegated that responsibility to the FDA, also known as the nation’s food safety agency.

After the comment period ended in April 2007, the FDA began the time consuming process of reading the views submitted by hundreds of citizens. It also developed, conducted and completed a health hazard assessment concerning gluten. This analysis took longer than the FDA anticipated. In the time between the rule being proposed and the completion of the health assessment, other countries had made strides in adopting their own gluten-free labeling standards. Over the same time period, there was exponential growth in gluten-free manufacturing, so the FDA decided to ask for additional input from the public in August 2011. Asking for public comments again is not common and adds time to the overall process.

As is standard practice, the agency proposing the rule, has to review all those comments and determine whether changes should be made as a result. Comments are a matter of public record and you can read them in your free time. After that review, FDA drafted the final rule. It was then sent to HHS for review. The Secretary approved FDA’s work then forwarded the package to the Office of Management and Budget (OMB). This is the last hurdle in the process that began when FALCPA became law way back in August 2004.

If the FDA made no changes to its proposal, and OMB approves it, then manufacturers will only be permitted to use a “gluten-free” label on foods if the product does not contain any of the following:

1. An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains;

2. An ingredient derived from these grains and that has not been processed to remove gluten;

3. An ingredient derived from these grains and that has been processed to
remove gluten, if it results in the food containing 20 or more parts per
million (ppm) gluten; or,

4. 20 ppm or more gluten.

Does this sound familiar? It should! The same threshold – 20 ppm – is the Codex Alimentarius standard that has been used in the international arena for several years.

This may seem like a drawn out process, but it serves to make sure the end products meets the needs of our community. Once the rule takes effect, it will minimize confusion, prevent misbranding and provide a much needed and anticipated standard for the term “Gluten-Free.”