Dear Mrs. Koller-Kass:
Thank you for getting in touch with me about the Food Allergen Labeling and Consumer Protection Act
 (FALCPA) and the implementation of the “gluten-free” labeling rules.  I have received letters from a number
 of Ohioans with celiac disease who are concerned about “gluten-free” labeling and I understand the difficulty
 faced by individuals with food allergies and food intolerances.  
As you mentioned, in an effort to assist persons with celiac disease avoid sources of gluten, the FALCPA
directed the Food and Drug Administration (FDA) to develop and implement rules for the labeling of
gluten-free food.  After receiving your letter, I contacted the FDA and asked for an update on their efforts to
 implement labeling regulations for gluten-free foods.
In 2007, FDA published a proposed rule (72 Federal Register 2817) on “gluten-free” labeling.  In the rule,
 FDA proposed that foods labeled “gluten-free” cannot contain any of the grains wheat, rye, barley, or their
crossbred hybrids (e.g., triticale), or 20 parts per million or more gluten.  In the proposed rule, FDA committed
 to conducting a safety assessment on gluten exposure in individuals with celiac disease, in order gain more
knowledge about how to define the term “gluten-free.”  FDA informs me that they have completed the safety
 assessment, which also underwent an expert peer review.  FDA is now in the process of reviewing the
 comments of the peer reviewers so that they can make whatever changes are warranted in the safety
 assessment before its availability for public comment (which will be announced by a notice in the Federal
 Register).  FDA could not give me a date certain of when the safety assessment will be available for public
 comment, but they say it will be in the near future.  In developing the final rule on “gluten-free” food labeling,
 FDA will consider comments received on the proposed rule and on the notice about the safety assessment,
 as well as the findings of the safety assessment.
An estimated 3 million Americans living with celiac disease depend on the availability of gluten-free foods to
combat their disease.  I believe it is imperative to make sure foods containing allergens are clearly labeled and
that FDA act quickly to help bring clarity to “gluten-free” labeling.  I will stay in touch with FDA about
“gluten-free” labeling and if you would like to read some frequently asked questions about this issue, please visit
Thank you again for bringing this important issue to my attention.
                         Sherrod Brown
                         United States Senator
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