FDA announces standards for “Gluten-Free” labeling

Last week, the Food and Drug Administration announced new standards for “Gluten Free” labeling that apply to certain foods and dietary supplements.  Thirty percent of American adults claim to cut down on or avoid gluten, according to research by the NPD group.

Under the new regulations, in order to be labeled “gluten-free,” “no gluten,” “free of gluten,” or “without gluten,” a food product must contain less than 20 parts per million of gluten.  The FDA estimated that before the labeling regulations took affect, 5 percent of foods bearing “gluten-free” labels contained more than 20 parts per million of gluten.  The FDA will allow foods to be labeled “gluten-free” when the food is inherently gluten-free, or it contains no gluten-containing grain, ingredient derived from a gluten-containing grain from which the gluten has not been removed, or ingredient derived from a gluten-containing grain from which the gluten has been removed if the gluten content remains above 20 parts per million.

The rule applies to foods and dietary supplements that are regulated by the FDA but does not apply to products regulated by the USDA, such as meat and eggs, and products regulated by the Alcohol and Tobacco Tax and Trade Bureau, such as alcoholic beverages.  The FDA does not require manufacturers to test for gluten content before making “gluten-free” claims, but any “gluten-free” product found to contain more than 20 ppm of gluten will be deemed “misbranded.”

The information provided in this blog post is generic and based on the general definitions and provisions of FDA regulations as well as other FDA publications.  This blog post and the information it contains should not be interpreted as legal advice for any specific situation.  Individuals with specific questions about their business are encouraged to consult an attorney.

photo by Emily Carlin