FDA Standardizes Gluten-Free Labeling

In August 2013, the Food and Drug Administration issued a final rule that defined what characteristics a food has to have to bear a label that proclaims it “gluten-free.” The rule also holds foods labeled “without gluten,” “free of gluten,” and “no gluten” to the same standard. Manufacturers had one year to bring their labels into compliance.

As of August 5, 2014, any product bearing the description “gluten-free” must contain less than 20 parts-per-million (ppm) of gluten.  This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA now 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
  • 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

Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” if they inherently don’t have any gluten.

Under the final rule, 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 requirements of the rule is considered misbranded and subject to regulatory action by FDA.

Incorrectly-marked gluten-free products may still be on the shelves at grocery stores as grocery stores transition to stocking FDA-approved gluten-free foods. If consumers have any doubts about a product’s ingredients and whether or not the product is gluten-free, they should contact the manufacturer or check its website for more information.

The new rules don’t apply to alcoholic beverages or food served at restaurants, but the FDA encourages wide observance of the regulation.

References:

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