Breaking Bread News: FDA Sets Gluten-Free Labeling Standard at Last!

After years of waiting, a standard for labeling foods gluten-free has finally been set by the Food and Drug Administration (FDA). Gluten, a substance found in wheat, barley, and rye, as well as in the foods made from these grains, causes autoimmune reactions in at least three million Americans, posing a threat to their health.

A Long-Awaited Regulation

It all began in 2004 when Congress initially passed a law mandating a standard for gluten-free food labeling. The pressure on the FDA to establish a standard has recently grown, with the gluten-free foods market now valued at over $4 billion a year.

With the newly established rule, the FDA sets a limit of 20 parts per million of gluten for foods labeled gluten-free. Many European countries have already adopted this restriction, and it was widely anticipated that the FDA would follow suit.

Dr. Alessio Fasano, director of the Center for Celiac Research at Massachusetts General Hospital in Boston, rightfully considers this rule a “big deal.” This regulation allows those with celiac disease, an autoimmune condition sensitive to gluten, peace of mind knowing that products labeled gluten-free are safe for them to eat.

As Dr. Fasano explains, “A gluten-free diet for people with celiac disease is like insulin for diabetics.” The implementation of this rule means that the FDA can now seize mislabeled gluten-free food and, if necessary, enforce product recalls.

Why is Gluten Harmful to Some People?

For people with celiac disease, consuming gluten can lead to a range of health issues^[1^]. When they eat foods containing gluten, their body mounts an immune response, damaging the small intestine’s lining. This attack reduces the intestine’s ability to absorb nutrients, potentially leading to malnutrition and various related health complications.

That’s why this FDA regulation is so critical, as it aims to help prevent accidental gluten exposure to people who need a strict gluten-free diet. Although this diet was initially a necessity for people with celiac disease, it has gained traction for its perceived health benefits for a broader population^[2^]. However, it’s essential to note that adhering to a gluten-free diet when not medically required may not always confer additional health benefits and can limit one’s nutrient intake.

The Role of Gluten-Free Labeling in Everyday Life

While 1% of Americans have celiac disease, experts estimate that an additional 6% of the population may have non-celiac gluten sensitivity (NCGS)^[3^]. People with NCGS experience symptoms after consuming gluten but do not have the same intestinal damage observed in those with celiac disease. Although the exact causes of NCGS are still uncertain, the FDA’s gluten-free labeling rules benefit this part of the population as well.

With the growing interest in gluten-free diets for various health reasons, clear and consistent labeling has become increasingly important. Avoiding gluten can be a challenge, as it is present in many foods and can sometimes remain invisible. The strict labeling guidelines mandated by the FDA will make it easier for people with celiac disease or gluten sensitivity to choose appropriate products confidently.

Knowing the exact contents of a product is also crucial for parents and caregivers who need to watch out for potential allergens in children’s diets. This regulation will give them an invaluable resource to make the healthiest food choices for their family members with gluten intolerance or sensitivity.

Labeling Guidelines

To comply with the FDA’s regulation, a food must meet the following requirements to be labeled gluten-free^[4^]:

  • It must inherently be gluten-free (like a raw fruit or vegetable)
  • Any unavoidable gluten presence must be less than 20 parts per million due to cross-contact
  • It must not contain an ingredient derived from a gluten-containing grain (unless the gluten has been removed to an extent that results in fewer than 20 parts per million)
  • It must not contain an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (like modified wheat starch)

These guidelines will ensure that people with celiac disease and gluten sensitivity have access to accurate information about the foods they consume. When consumers select products that are labeled gluten-free, they can trust the accuracy of the claim.


The FDA’s long-awaited standard for labeling foods gluten-free is a huge leap forward for people with celiac disease and gluten sensitivity. Now, consumers can trust that a product labeled gluten-free complies with strict guidelines and contains less than 20 parts per million of gluten.

Accurate and reliable gluten-free food labeling is essential not only for those with diagnosed celiac disease or gluten sensitivity but also for parents and caregivers purchasing on behalf of others. By offering clear and consistent information on food packaging, the gluten-free community can make informed, safe decisions about the foods they consume, ultimately leading to improved health and well-being.