<<Disclaimer: Verify this information before applying it to your situation.>>

The FDA has distributed the following information regarding its new GF 
labeling proposal:
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:

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

Currently, there is no Federal regulation that defines the term 
 "gluten-free" used in the labeling of foods.  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.

The proposed rule has a 90-day public comment period.  Interested persons 
can submit comments electronically or in writing as per instructions 
provided in Docket No. 2005N-0279, available via the following web-link: 
http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-843.htm

A document titled "Questions and Answers on the Gluten-Free Labeling 
Proposed Rule has been prepared by FDA and is available at the following 
web-link:  http://www.cfsan.fda.gov/~dms/glutqa.html


Andrea Levario, J.D.
Executive Director
American Celiac Disease Alliance
4331 E. Baseline Road
Ste B105 - # 216
Gilbert, AZ   85234-2961
(703) 622-3331
[log in to unmask]
www.AmericanCeliac.org

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