This level is the lowest that can be reliably detected in foods using scientifically validated analytical methods. The rule specifies, among other criteria, that any foods that carry the label “gluten-free,” “no gluten,” “free of gluten,” or “without gluten” must contain less than 20 parts per million (ppm) of gluten. Accordingly, manufacturers that label their foods as free of gluten are responsible for using the claim in an accurate and not misleading manner, and for complying with all requirements established by the regulation and enforced by FDA. While “gluten-free” is a voluntary claim that manufacturers may choose to use in the labeling of their foods, FDA’s gluten-free food labeling rule specifies what the claim actually means on a food label. But, for the estimated 3 million Americans suffering from celiac disease, consuming gluten causes damage to the lining of the small intestine which prevents absorption of vital nutrients causing deficiencies that can lead to serious conditions, including anemia, osteoporosis, diabetes, thyroid disease, and intestinal cancers.

Gluten is the substance that gives breads and other grain products their shape, strength, and texture.

Foods that typically contain gluten include breads, cakes, cereals, pastas, and many other grain-based foods. Gluten occurs naturally in wheat, rye, barley, and crossbreeds of these grains. The gluten-free labeling regulation gives consumers a standardized tool for managing their health and dietary intake - especially those with celiac disease, an auto-immune reaction to eating gluten, a protein found in wheat, barley and rye. Food and Drug Administration (FDA) has required that claims on food labels that a food contains no gluten meet a clear standard that assures consumers that “gluten-free” claims on food products will be truthful and consistent.

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