Gluten Free
the term ``gluten-free'' for voluntary use in the labeling of foods, to
mean that the food does not contain any of the following: An ingredient
that is any species of the grains wheat, rye, barley, or a crossbred
hybrid of these grains (all noted grains are collectively referred to
as ``prohibited grains''); an ingredient that is derived from a
prohibited grain and that has not been processed to remove gluten
(e.g., wheat flour); an ingredient that is derived from a prohibited
grain and that has been processed to remove gluten (e.g., wheat
starch), if the use of that ingredient results in the presence of 20
parts per million (ppm) or more gluten in the food; or 20 ppm or more
gluten. A food that bears the claim ``gluten-free'' or similar claim in
its labeling and fails to meet the conditions specified in the proposed
definition of ``gluten-free'' would be deemed misbranded. FDA also is
proposing to deem misbranded a food bearing a gluten-free claim in its
labeling if the food is inherently free of gluten and if the claim does
not refer to all foods of that same type (e.g., ``milk, a gluten-free
food'' or ``all milk is gluten-free'').
In addition, a food made from oats that bears a gluten-free claim in its labeling would be deemed
misbranded if the claim suggests that all such foods are gluten-free or
if 20 ppm or more gluten is present in the food.
Establishing a definition of the term ``gluten-free'' and uniform conditions for its
use in the labeling of foods is needed to ensure that individuals with
celiac disease are not misled and are provided with truthful and
accurate information with respect to foods so labeled. This proposed
action is in response to the Food Allergen Labeling and Consumer
Protection Act of 2004 (FALCPA).



















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