FDA Reopens Comment Period on Proposed ‘Gluten-Free’ Food Labeling

 

On Tuesday, August 02, 2011 the United States Food and Drug Administration held a conference call to discuss re-opening the comment period for Gluten Free Labeling.  The Press Release announcing the call was not posted until August 2nd, the day of the call.  I know that many of you were unable participate due to the late notice, however, the call was recorded, and will be available for your listening pleasure until September 2, 2011.  The replay of the call can be heard by dialing (866) 415-8391.

The U.S. Food and Drug Administration has stated that their goal for labeling gluten free foods is to: Eliminate uncertainty about how food producers may label their products, and to assure consumers who must avoid gluten that foods labeled “gluten-free” meet a clear standard established and enforced by FDA.
The FDA is seeking comments from the public, so this is your opportunity to have your voices heard.   The agency is particularly interested in the health effects of gluten including cross contamination in people with celiac disease or those who are gluten sensitive.  The comment period will officially open after noon on Aug. 3, 2011, and will remain open for 60 days (October 2, 2011).
To submit comments electronically, go to www.regulations.gov and choose:
“Submit a Comment” from the top task bar.
Enter the docket number FDA-2005-N-0404 in the “Keyword” space
Select “Search”
Post your comment.

The 2004 Food Allergen Labeling and Consumer Protection Act mandated that the Food and Drug Administration designate a federal standard for the term “gluten free” by 2008.  Obviously that deadline has come and gone and little progress has been made.  Under pressure from Advocacy Groups, Senators and Congressmen, the FDA has re-opened the comment period.  If comments are not received they will proceed with the definition that was published on January 23, 2007 (This proposed ruling can be viewed in PDF format on www.regulations.gov).  The following details the FDA proposed definition which would allow manufacturers to label a food “gluten-free” if the food does not contain any of the following:

  1. an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
  2. an ingredient derived from these grains and that has not been processed to remove gluten
  3. an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
  4. 20 ppm or more gluten

Highlights of the Conference Call

The public participants taking part in the call included an eclectic mix of Doctors, Researchers, Manufacturers, Celiac Disease Advocates, Writers/Bloggers, and Consumers.  I will highlight what I deemed to be some of the most important comments from the call.
1.               Dr. Alessio Fasano from the University of Maryland, Center for Celiac Research stated that 20 ppm does not correlate to an actual measurement of Milligrams in a product.  20ppm is simply a threshold measurement.
2.               Dr. Guandalini of The University of Chicago Celiac Disease Center Research Program stated that the threshold of 20ppm should be accepted for U.S. standards as it is in other parts of the World.
3.               Carolyn Lynch McKinley with the Celiac Sprue Association asked if the FDA had reviewed the effects of ingesting more than 20ppm of gluten per day.  The response from Rhonda Kane, a Consumer Safety Officer with the FDA was that the FDA is still looking for more information from Researchers and Doctors on threshold levels.
4.               The question was raised about what testing substrates would be used for the detection of gluten in manufacturing facilities.  The response was the R5 ELISA (Mendez Method) and the Morinaga Wheat Protein ELISA Test (which is used by the Government of Japan).
5.               Alicia Woodward from Living Without Magazine asked the FDA if the planned to label products such as Alcoholic Beverages and Cosmetics.  The answer from the FDA was no.  The FDA will only be labeling food that is for human consumption.
6.               Gwen Smith from Allergic Living asked if Oats would be included in the list of Gluten Containing Grains.  The FDA responded that Oats would not be considered gluten containing. 
7.               The FDA was asked when the Gluten Free Labeling would be approved the response was possibly the 3rd Quarter of 2012.
8.               There were many questions about enforcement of the labeling standards but the FDA responded by saying a “compliance program” would be established.
9.               When asked about a standardized Gluten Free Symbol that would be used on packaging the FDA said that was not currently in the plan.
I will be submitting my comments not only to the United States Food and Drug Administration, but to the United States Committee on Agriculture, Nutrition and Forestry as they oversee the FDA.  I personally am not comfortable with the definition published by the FDA in 2007.  I hope that each of you will submit your comments so that your voices can also be heard and your concerns addressed by the committee.
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