FDA Seeks YOUR input on Gluten Free Labeling Standards beginning August 3
FDA NEWS RELEASEFor Immediate Release: Aug. 2, 2011
Media Inquiries: Siobhan DeLancey, 202-510-4177, siobhan.delancey@fda.hhs.gov
Trade Inquiries: Stephen King, 240-402-1407, stephen.king@fda.hhs.gov
Consumer Inquiries: 888-INFO-FDA
FDA reopens comment period on proposed ‘gluten-free’ food labeling rule
Rule would help by creating a uniform and enforceable definition
To submit your comments electronically to the docket go to www.regulations.gov
1. Choose “Submit a Comment” from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”
To submit your comments to the docket by mail, use the following address:
The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852 Include docket number FDA-2005-N-0404 on each page of your written comments.
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852 Include docket number FDA-2005-N-0404 on each page of your written comments.
The U.S. Food and Drug Administration today reopened the comment period for its 2007 proposal on labeling foods as “gluten-free.” The agency is also making available a safety assessment of exposure to gluten for people with celiac disease (CD) and invites comment on these additional data.
One of the criteria proposed is that foods bearing the claim cannot contain 20 parts per million (ppm) or more gluten. The agency based the proposal, in part, on the available methods for gluten detection. The validated methods could not reliably detect the amount of gluten in a food when the level was less than 20 ppm. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries.
People who have celiac disease cannot tolerate gluten, a protein in wheat, rye, and barley. Celiac disease damages the small intestine and interferes with absorption of nutrients from food. About 1 percent of the United States population is estimated to have the disease.
“Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance,” said Michael Taylor, deputy commissioner for foods. “We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”
The proposed rule conforms to the standard set by the Codex Alimentarius Commission in 2008, which requires that foods labeled as “gluten-free” not contain more than 20 ppm gluten. This standard has been adopted in regulations by the 27 countries composing the Commission of European Communities.
The FDA encourages members of the food industry, state and local governments, consumers, and other interested parties to offer comments and suggestions about gluten-free labeling in docket number FDA-2005-N-0404 at www.regulations.gov. The docket will officially open for comments after noon on Aug 3, 2011 and will remain open for 60 days.
To submit your comments electronically to the docket go to www.regulations.gov
1. Choose “Submit a Comment” from the top task bar
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”
2. Enter the docket number FDA-2005-N-0404 in the “Keyword” space
3. Select “Search”
To submit your comments to the docket by mail, use the following address:
The Division of Dockets Management
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
HFA-305
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852
Include docket number FDA-2005-N-0404 on each page of your written comments.
For more information:
Federal Register Notice (scroll to FDA–temporary link will update when document publishes on Aug. 3):
Gluten-Free Portal (scroll to Gluten-Free):
FDA’s Proposed Rule on the Gluten-Free Labeling of Foods: http://www.fda.gov/Food/LabelingNutrition/FoodAllergensLabeling/GuidanceComplianceRegulatoryInformation/ucm077926.htm
Questions and Answers on the Gluten-Free Labeling Proposed Rule:
Consumer Update on the Gluten-Free Labeling Proposed Rule:
Celiacs represent 1 person out of every 130. Those persons, with the Allergy, are a much higher percentage. Add to that, the persons with sensitivities to gluten. 5 yrs ago this was 5%, of the population, Today, this is 18%, of the population. Labels are vital, but factories must employ good cross contamination practices.
The long term solution, is to reverse engineer, the wheat seeds. All purpose flour now has 90% more gluten in it, than it did, 30 years ago…
The problem is that manufacturers are going “gluten free” and using products that are derived from CORN instead of from WHEAT, BARLEY, and RYE. As a result, those who suffer from Celiac Disease AND also suffer from Corn allergy are having an even harder time finding products that are safe to consume. Since the FDA does not recognize CORN as one of it’s “BIG 8″ allergens, manufacturers are NOT REQUIRED to list ingredients derived from CORN on product labeling by its common name, CORN. This is simply a travesty for the millions of CORN allergen sufferers in the United States and the world. We need the FDA to include CORN into its recognized allergens group for product labeling so that those who suffer from CORN allergy will be able to easily identify contaminated products and avoid them.
I’m really tired of the whole “trial and error” thing just because an ingredient that’s listed may or may not have gluten in it. At the very least, labels should be clearer on whether or not the ambiguous ingredients are something I should be avoiding or not. The same goes for soy. Approximately 1/8 of those sensitive to gluten are also sensitive to soy. Again, this is an ingredient that is sometimes ambiguous. I shouldn’t have to eat something new and hope it doesn’t send me to the hospital. No one should.
I would really like it if the FDA would list corn as an allergy. I found out a year ago that I was very allergic to corn. It is really hard trying to find out if the maltodestrine or the modified food starch that is listed on a product is from corn, potato or tapioca when most of the companies themselves are not sure which they use at the time when I call or email. In the end I end up not buying any product I am not sure of because of the risk.