켐론FDA코리아

The Food and Drug Administration (FDA) has issued a final rule that defines what characteristics a food has to have to bear a label that proclaims it \"gluten- free.\"

This rule has been eagerly awaited by advocates for people with celiac disease, who face potentially life-threatening illnesses if they eat the gluten found in breads, cakes, cereals, pastas and many other foods.

As one of the criteria for using the claim \"gluten-free,\" FDA is setting a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. 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 standard \'gluten-free\' definition will eliminate uncertainty about how food producers label their products and will assure people with celiac disease that foods labeled \'gluten-free\' meet a clear standard established and enforced by FDA,\" says Michael R. Taylor, J.D., deputy FDA commissioner for foods and veterinary medicine.

What Is Gluten?

Gluten means the proteins that occur naturally in wheat, rye, barley, and crossbreeds of these grains.

As many as 3 million people in the United States have celiac disease. It occurs when the body\'s natural defense system reacts to gluten by attacking the lining of the small intestine. Without a healthy intestinal lining, the body cannot absorb the nutrients it needs. Delayed growth and nutrient deficiencies can result and may lead to conditions such as anemia (a lower than normal number of red blood cells) and osteoporosis, a disease in which bones become fragile and more likely to break. Other serious health problems may include diabetes, autoimmune thyroid disease and intestinal cancers.

Before the rule there were no federal standards or definitions for the food industry to use in labeling products \"gluten-free.\" An estimated 5 percent of foods currently labeled \"gluten-free\" contain 20 ppm or more of gluten.

How Does FDA Define \'Gluten-Free\'?

In addition to limiting the unavoidable presence of gluten to less than 20 ppm, FDA will allow manufacturers to label a food \"gluten-free\" if the food does 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

Under the new 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 would be considered misbranded and subject to regulatory action by FDA.