FDA update: Gluten-free rule now in effect

In All, Food Products, General by Keri Szejda


Some ingredients, though safe for most people, can have devastating effects on certain individuals. Such is the case with gluten and people who have celiac disease or non-celiac gluten sensitivity.

Gluten is a protein naturally found in a number of grains including wheat, rye, and barley. It gives dough an elastic feel, contributing to the texture of bread, pasta and pizza dough that many of us prefer. It’s also an ingredient in an unimaginably long list of food products. Consider just a few examples of gluten-containing foods: bread, of course, but also soy sauce, vegetarian meat-substitutes, salad dressings, and beer.

For people who need to avoid gluten, a trip to the grocery store can be burdensome, confusing, and require a lot of time reading ingredient lists and trying to uncover gluten-containing ingredients. (Malt vinegar? Wheat starch? Soy sauce? Oats that are cross-contaminated? Dextrin sourced from wheat?… You get the picture).

For people who suffer from the autoimmune disorder called celiac disease, eating gluten triggers an immune response in their small intestine. Untreated, the condition causes inflammation, damages the villi (hair-like that line the small intestine), and can prevent nutrients from being absorbed, leading to a range of health complications. Celiac disease is estimated to effect about 1% of the US population. There is also a related condition called non-celiac gluten sensitivity, though there is greater ambiguity underlying the current scientific understanding of the condition. It is estimated that up to 6% of the US population may be affected by non-celiac gluten sensitivity.

What we do know is that for people diagnosed with celiac disease, gluten is a significant problem. Eliminating gluten from the diet is the only known treatment. And this is (much) easier said than done. So it’s really important for people with celiac disease to be confident that the gluten-free labeled products are indeed gluten-free.

The popularity of the gluten-free movement has meant that there are now many more food options for people who need, or actively choose, to avoid gluten. But until recently, there hasn’t been a specific meaning behind the gluten-free label.

Gluten free label now carries a specific meaning

A gluten-free label now carries a specific meaning: no more than 20 parts per million of gluten.

What does the gluten-free label mean?

In August 2016, a federal Food and Drug Administration (FDA) regulation went into effect that covers the specific requirements for gluten-free labeling in the United States. Specifically, if a product is labeled gluten-free the product can contain no more than 20 parts per million (ppm) of gluten – regardless of how that gluten got there (naturally occurring, added, cross contaminated, or otherwise).

This label helps to eliminate some of the burden and confusion associated with shopping for gluten-free food, reducing the need for an extensive ingredient search into whether a product possibly contains gluten. Some foods that are naturally free of gluten, such as oats, can suffer from cross-contamination of wheat either in the field or during processing. So the label offers an additional level of confidence beyond a full inspection of an ingredient list.

Gluten-free is not a required label, but rather it is a permitted label. Foods such as apples and milk, that are naturally free of gluten, aren’t required to be labeled gluten-free. But many companies are taking advantage of the gluten-free consumer market, and choosing to label many products that are naturally gluten-free (like tomatoes, bottled water, and cheese).

Why not just require the label to mean that there is absolutely no gluten in the product (0 ppm)? It’s a case of detection. The FDA reports that there are no valid methods for reliably detecting gluten in amounts lower than 20 parts per million. And thankfully current research suggests that most individuals with celiac disease can tolerate gluten in such small amounts.

There are some exceptions to the final FDA rule. The rule does not cover meat, poultry, and eggs (these are regulated by the United States Department of Agriculture), and most alcoholic beverages (these are regulated by the Alcohol and Tobacco Tax and Trade Bureau). The rule applies strictly to packaged foods. Though it is not part of the final rule, the FDA expects (encourages?) similar compliance with foods served in restaurants.

The gluten-free label adds a measure of confidence for people seeking to completely eliminate gluten from their diet. The label carries real meaning and can help people with celiac disease control their health. For more information on the labeling requirement, the FDA offers a Q & A page.