No longer do people with celiac disease have to wonder whether the foods they eat contain harmful amounts of gluten despite bearing a "gluten-free" label, as the Food and Drug Administration (FDA) has announced a formal rule for what defines a food as "gluten-free."

The FDA's recent classification will bring confidence to as many as three million people in the United States who suffer from celiac disease, an immune reaction to eating gluten that can cause a handful of ailments and illnesses. Under the new ruling, foods that bear a "gluten-free" label must meet specific standards set by the FDA.

Making It Official

The regulation was published August 1, and manufacturers have one year from publication to have their labels approved. Under the new guidelines, foods need to have fewer than 20 ppm (parts per million) of gluten in order to be called "gluten-free," according to a statement released by the FDA.

This is the lowest level that science can reasonably detect with existing capabilities.

"This standard 'gluten-free' definition will eliminate uncertainty about how food producers label their products," said Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine, "and will assure people with celiac disease that foods labeled 'gluten-free' meet a clear standard established and enforced by FDA."

Additionally, foods that do not contain even trace amounts of gluten can meet the criteria. According to the FDA's statement, foods can also be labeled "gluten-free" if they do not contain any of the following:

1. An ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains

2. An ingredient derived from these grains and that has not been processed to remove gluten

3. 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

For these reasons, bottled water, fruits and vegetables, and eggs can bear "gluten-free" labels if their manufacturer so chooses.

The Benefit For Celiac Patients

Before publication, no official regulation controlled labeling procedures. An estimated five percent of foods bearing the label contained levels of gluten over 20 ppm. These uncertainties made life with celiac disease much harder, as eating gluten-free foods often came with the risk of improper labeling, according to Andrea Levario, executive director of the American Celiac Disease Alliance (ACDA).

"This is a tool that has been desperately needed," Levario said. "It keeps food safe for this population, gives them the tools they need to manage their health, and obviously has long-term benefits for them."

The FDA adds that people with celiac disease can often tolerate minimal amounts of gluten; however, the issue of transparency has long plagued the food industry when it comes to consumer awareness. The new regulation has echoes of many GMO crops, whose labels seldom provide enough information, many advocates have argued. Gluten-free regulation helps concretize the once ambiguous labeling standards, others add.

"Without proper food labeling regulation, celiac patients cannot know what the words 'gluten free' mean when they see them on a food label," said Allessio Fasano, M.D., director of the Center for Celiac Research at MassGeneral Hospital for Children and member of the ACDA.

Gluten, Defined

Gluten comprises the set of proteins found naturally in wheat, rye, barley, and crossbreeds of these grains. People with celiac disease experience adverse reactions to gluten because the disease attacks the lining of the small intestine, preventing any nutrients from being absorbed. As a result, people with celiac disease often see delayed growth or nutrient deficiencies.

Over time, these can develop into more serious conditions, such as anemia (a deficiency of red blood cells), osteoporosis, diabetes, autoimmune thyroid disease, and intestinal cancers.

According to the FDA, manufacturers whose food meets the regulation can also label their products as "free of gluten," "without gluten," and "no gluten." If shown to be invalid via the guidelines, making such claims can lead to regulatory action from the FDA.

Overall, however, experts agree the new regulation can only move the food industry, as well as sufferers of celiac disease, further toward progress.

"This is a huge victory for people with celiac disease," said Levario. "In fact, that's the understatement of the year."