FDA Proposes to Define the Term "Gluten-Free" for Voluntary Use in Food

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* U.S. Food and Drug Administration *
* Center for Food Safety and Applied Nutrition *

CONSTITUENT UPDATE

Constituent Updates are also available on the web at
http://www.cfsan.fda.gov/~dms/cfsupdat.html.


January 23, 2007


FDA Proposes to Define the Term "Gluten-Free" for Voluntary Use in Food
Labeling

The Food and Drug Administration (FDA) has published a proposed rule in
the Federal Register, Docket No. 2005N-0279, titled "Food-Labeling:
Gluten Free Labeling of Foods." Included in the proposed rule is a
definition established by the FDA for the term "gluten-free" for
voluntary use in the labeling of foods. A definition for the term
"gluten-free" would assist those who have celiac disease (also know as
celiac spue or gluten-sensitive enteropathy) and their caregivers to
more easily identify packaged foods that are safe for persons with
celiac disease to eat. Celiac disease occurs in genetically susceptible
individuals and causes damage to their small intestine when they consume
gluten found in "prohibited grains". Celiac disease has no cure, but
avoiding the consumption of gluten can resolve its symptoms, mitigate
and possibly reverse damage, and reduce associated health risks. This
proposed rule has been prepared in response to the Food Allergen
Labeling and Consumer Protection Act of 2004, Title II of Public Law
108-282, enacted on August 2, 2004, which directs the Secretary of the
Department of Health and Human Services to propose, and later make
final, a rule that defines and permits the use of the food labeling term
"gluten-free".

FDA is proposing to define the food labeling term "gluten-free" to mean
that a food bearing this claim does not contain any of the following:

* an ingredient that is a "prohibited grain", which refers to any
species of wheat (e.g., durum wheat, spelt wheat, or kamut), rye, barley
or their crossbred hybrids;

* an ingredient (e.g., wheat flour) that is derived from a "prohibited
grain" and that has not been processed to remove gluten;

* an ingredient (e.g., wheat starch) that is derived from a "prohibited
grain" that has been processed to remove gluten, if the use of that
ingredient results in the presence of 20 micrograms or more gluten per
gram of food,

* or 20 micrograms or more gluten per gram of food.

A food that bears the claim "gluten-free" or a similar claim (e.g. "free
of gluten", "without gluten", "no gluten") in its labeling and fails to
meet the conditions specified in the proposed definition of
"gluten-free" would be deemed misbranded.

[COLOR="Red"]Currently, there is no Federal regulation that defines the term
"gluten-free" used in the labeling of foods.[/COLOR] Based upon comments FDA
received during its public meeting on "gluten-free" food labeling held
in August 2005 and other information available to the Agency, there is
no universal understanding among U.S. food manufacturers or consumers
about the meaning of a food labeled as "gluten-free." FDA believes that
establishing a definition for the term "gluten-free" and uniform
conditions for its use in the labeling of foods will ensure that persons
with celiac disease are not misled and are provided with truthful and
accurate information.

I'm glad I don't have a gluten intolerance however for those who do, the mislabeling of the term "gluten free" could be a real problem. It's like when companies say "zero carbs" when really there is a trace amount.

[Warrior Woman]

It is crazy. It sucks having celiac. Looking at labels they have to state if there is wheat- but as above, not gluten. Since gluten is used to thicken food, you would have to look at all the ingreidents. It is boggoling, annoying, and painful when I do eat it