The FDA Defines “Gluten-Free” for Food Labels

On August 2, 2013, the FDA published its new regulation defining the term “gluten-free” for food labeling. The wait for this regulation has been a full decade in the making. About ten years ago, the Food Allergen Labeling and Consumer Protection Act (FALCPA) made it a requirement for foods containing the top eight food allergens to be labeled as such.

A second part of the requirement by FALCPA required the FDA to define the regulations for the label “gluten-free”. This second requirement is what took so very long to finalize. After much investigation and two public comment periods, the FDA published its regulation, following in a manner consistent with countries around the world.

The European Union and Canada already have such a regulation courtesy of the World Health Organization that set the Codex Alimentarius labeling guidelines. The FDA’s definition of “gluten-free” is exactly the same as that recommended by the World Health Organization – a threshold of 20 ppm (parts per million) or less of gluten.

When Do Labels Need to Comply with the New Regulation?

Just because it’s finally official, doesn’t mean that all food so labeled is suddenly correct according to this regulation. Manufacturers are being asked to adjust their labels to the new regulation requirements as soon as possible, but factually they have a full year to get their labels into compliance. The “gluten-free” definition will also hold true for those products that use similar terms on their labels such as “no gluten”, “free of gluten” and “without gluten” – they must all meet the new standard.

For those with celiac disease and gluten sensitivity, such labels are, obviously extremely important. And for most, adequate. Unfortunately, some individuals are more sensitive and find themselves reacting to products that fall within the 20 ppm or less threshold.

The gluten-free food industry is a fast-growing one, doubling yearly since 2011. The Nutrition Business Journal estimates revenue at over eight billion dollars by 2015! With the FDA regulation officially published, it is thought that more new products will be added to this robust marketplace.

Why Can’t “Gluten-Free” Mean Zero Gluten?

If you’re wondering why 20 ppm is the law instead of 10 or 5 or zero, you’re not alone. That is why much of the discussion occurred over the last decade. While zero would definitely be ideal, 20 ppm was picked because the equipment measuring the presence of gluten is only sensitive to 20 and, research has seen that for many (and it is thought, for most) suffering from celiac disease, a reaction tends not to occur as long as the food is within the threshold of 20 ppm or less.

Here at Root Cause Medical Clinic, our clinical nutrition department definitely meets patients who react to foods with this level of gluten and for them, eating can be a large challenge. Often, fortunately, we find that improving their immune system and healing their leaky gut through addressing the secondary effects of gluten, makes a big difference in their ability to tolerate these trace amounts.