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FDA sets ‘gluten-free’ labeling standards

With a final ruling issued by the Food and Drug Administration (FDA), people with celiac disease can now trust “gluten-free” labels on food.

The rule defines what food characteristics are necessary to bear a gluten-free label, also holding foods labeled as “without gluten,” “free of gluten,” and “no gluten” to the same standard. Celiac advocates have long awaited this decree.

Any foods that carry the label “gluten-free” must not exceed a gluten limit of 20 ppm (parts per million), as this is the lowest level that can be consistently detected using valid analytical tools. Most people with celiac can tolerate very small amounts of gluten, and this level is consistent with international food safety standards.

According to FDA deputy commissioner, Michael R. Taylor, having a standard “gluten-free” definition will eliminate uncertainty about food labeling and assure those with celiac disease that foods labeled as such meet a clear, FDA-enforced standard.

There is no cure for celiac disease. As such, the only way to manage the disease is through dietary restriction. Before a legal definition existed, consumers could not have complete confidence in the “gluten-free” food label.

As Andrea Levario, executive director of the American Celiac Disease Alliance, put it, this desperately needed tool will provide this segment of the population with the necessary means to manage their health.

Currently, there are as many as 3 million people living in the United States with celiac disease. Celiac disease occurs when the body reacts to gluten by attacking the lining of the small intestine, preventing absorption of essential nutrients, which can result in delayed growth and nutrient deficiencies. It can also lead to conditions such as anemia, osteoporosis, diabetes, and intestinal cancers.

Previously there were no federal labeling standards for the food industry as far as gluten-free was concerned. It’s been estimated that up to 5 percent of foods currently labeled as “gluten-free” contain at least 20 ppm of gluten.

In addition to the 20 ppm limit, manufacturers will be able to label a food as “gluten-free” if it does not contain any of the following: any type of wheat, rye, barley, or crossbreeds; an ingredient derived from these grains, which has not been processed to remove gluten, or if processing results in concentrations greater than 20 ppm of gluten.

The regulation will be published August 5th. Manufacturers will have one year from this date to bring labels into compliance. Under the new rule, any label that fails to meet requirements will be considered misbranded and subject to regulatory action.