What is Gluten?
How Does FDA Define
Reprinted from FDA.gov
People with celiac disease can now have confidence in the
meaning of a "gluten-free" label on foods.
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." The rule also holds
foods labeled "without gluten," "free of gluten," and "no
gluten" to the same standard.
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 level is consistent with those set by other
countries and international bodies that set food safety
"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.
Andrea Levario, executive director of the American Celiac
Disease Alliance, notes that there is no cure for celiac
disease and the only way to manage the disease is dietaryŚnot
eating gluten. Without a legal definition of "gluten-free,"
these consumers could never really be sure if their body would
tolerate a food with that label, she adds.
"This is a tool that has been desperately needed," Levario
says. "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."
"Without proper food labeling regulation, celiac patients
cannot know what the words 'gluten free' mean when they see
them on a food label," says Allessio Fasano, M.D., director of
the Center for Celiac Research at MassGeneral Hospital for
Children, visiting professor of pediatrics at Harvard Medical
School and member of the American Celiac Disease Alliance.
What Is Gluten?
Gluten means the proteins
that occur naturally in wheat, rye, barley, and crossbreeds of
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
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:
- an ingredient that is any
type of wheat, rye, barley, or crossbreeds of these grains
- an ingredient derived from
these grains and that has not been processed to remove
- 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
Foods such as bottled spring
water, fruits and vegetables, and eggs can also be labeled
"gluten-free" if they inherently don't have any gluten.
The regulation will be published Aug. 5, 2014 in the Federal
Register, and manufacturers have one year from the publication
date to bring their labels into compliance. Taylor says he
believes many foods labeled "gluten free" may be able to meet
the new federal definition already. However, he adds, "We
encourage the food industry to come into compliance with the
rule as soon as possible."
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.
Those who need to know with certainty that a food is
gluten-free are heralding the arrival of this definition.
"This is a huge victory for people with celiac disease," says
Levario. "In fact, that's the understatement of the year."
Says Taylor, "FDA's 'gluten-free' definition will help people
make food choices with confidence."