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FDA’s Definition for “Gluten-Free” Labeling

FDA’s Definition for “Gluten-Free” Labeling

The Food and Drug Administration is the US agency responsible for defining “Gluten-Free” and for mandating gluten-free food labeling requirements. Gluten is a protein naturally found in grains such as wheat, rye and barley.

Nearly 3 million Americans have celiac disease, an autoimmune disease that damages the lining of the small intestine. When someone with celiac disease eats a gluten containing food, the body’s immune system overreacts to the proteins in gluten.

This causes an inflammatory response which damages the lining of the small intestine and impairs the ability to properly absorb nutrients from food. When unchecked, this can lead to very serious health issues long-term.

Many more people have a sensitivity to gluten (not the same as celiac disease) and experience GI discomfort like bloating or diarrhea when eating foods with gluten.

How Does FDA Define Gluten-Free? (from FDA.gov)

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA allows manufacturers to label a food “gluten-free” if the food does not contain any of the following:

  • an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains,
  • an ingredient derived from these grains and that has not been processed to remove gluten, or
  • an ingredient derived from these grains that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten

Foods that are inherently gluten-free, for example bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” provided any gluten that came in contact with the food is less than 20 ppm.

A food label that bears the claim “gluten-free,” as well as the claims “free of gluten,” “without gluten,” and “no gluten,” but fails to meet the FDA requirements for use of these terms is considered misbranded and subject to regulatory action by FDA.

There are no valid tests to detect gluten in foods that are hydrolyzed and fermented, like cheese and yogurt. So if they display a gluten-free claim, manufacturers must keep certain records to show that the foods meet “gluten-free” standards.

If you have any doubts about a product’s ingredients and whether or not the product is gluten-free, the FDA recommends that you should contact the manufacturer or check its website for more information.


“Not so obvious” ingredients that contain gluten:

  • Bulgur (form of wheat)
  • Couscous (made from wheat)
  • Farina (made from wheat)
  • Hordeum vulgare (barley)
  • Malt (made from barley)
  • Secale cereale (rye)
  • Seitan (made from wheat gluten)
  • Splelt or Triticum spelta
  • Triticum vulgare (wheat)
  • Triticale (wheat and rye cross)
  • Wheat or barley grass (will be cross contaminated)
  • Wheat germ oil or extract (will be cross contaminated)
  • Wheat protein or hydrolyzed wheat protein
  • Wheat starch or hydrolyzed wheat starch
  • Wheat flour or bread flour or bleached flour

Sometimes ingredient listings are more vague. Some ingredients can come from a variety of grains and the manufacturer may not specify which one they are using.

These are ingredients that may contain gluten:

  • Artificial flavor or artificial flavoring (can come from barley)
  • Dextrin and Maltodextrin (may be made from wheat)
  • Hydrolyzed plant protein (HPP) or Hydrolyzed vegetable protein (HVP) or Vegetable protein (can come from wheat, corn or soy)
  • Modified starch or modified food starch or vegetable starch (can come from wheat)
  • Natural flavor or natural flavoring (can come from barley)
  • Seasonings or flavorings

Ingredients are confusing and they don’t tell you everything. Even if the ingredients seem OK, gluten-free foods can be cross-contaminated with gluten-containing foods at the manufacturing plant and contain trace or more amounts of gluten, enough to cause a reaction in some people.

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