President’s Budget Highlights Gluten Free Labeling Proposal

Last August, FDA officials announced their intent to finalize the gluten-free labeling standard by late summer or early fall 2012.  That timeframe became a bit more real on February 13th when the President outlined the Administration’s budget and government’s spending priorities for the upcoming fiscal year.  The multi-thousand page budget is dry reading, particularly when trying to make sense of such large dollar figures.  Imagine skimming through the pages and running across the words ‘gluten-free,’ ‘labeling,’ and ‘celiac disease!’  Eight years after the Food Allergen Labeling and Consumer Protection Act (FALCPA) was signed into law, a national standard is within reach.

Department of Health and Human Services Fiscal Year 2013
Food and Drug Administration
Justification of Estimates forAppropriations Committees
Page 138

Gluten Allergy Labeling: For individuals with celiac disease, the only way to prevent harmful health effects is to adhere to a life-long diet free of gluten. In 2011, CFSAN conducted the following actions involving accurate gluten labeling of food products:

• Conducted and peer-reviewed a safety assessment of gluten exposure in
individuals with celiac disease, to provide further data on a possible alternative
approach to identifying a specific gluten threshold level as one of the criteria to
define “gluten-free.” FDA had previously issued a proposed rule in 2007 on
gluten-free food labeling that used an analytical methods-based approach to
propose less than 20 parts per million gluten as one of the criteria to define the
term “gluten-free.”

• Published a Federal Register notice in August 2011, reopening the comment
period on the Agency’s proposed rule on “gluten-free” food labeling. This notice
announced the availability of the Agency’s safety assessment on gluten
exposure in individuals with celiac disease and solicits public comment on the
safety assessment and a number of issues related to defining the term “glutenfree”
in a final rule. After FDA reviews and considers the comments, the Agency
intends to issue, by the end of fiscal year 2012, a final rule that defines
“glutenfree” for labeling food products, including dietary supplements.

(emphasis added)

While individuals with celiac disease in the U.S. await the completion of a national standard, countries in Europe, having already agreed on the 20ppm standard, are now moving toward a universal labeling symbol for gluten-free products.