FDA Reopens Comment Period on Proposed Gluten-free Food Labeling Rule
In 1994 I was diagnosed with celiac disease, which led me to create Celiac.com in 1995. I created this site for a single purpose: To help as many people as possible with celiac disease get diagnosed so they can begin to live happy, healthy gluten-free lives. Celiac.com was the first site on the Internet dedicated solely to celiac disease, and since then it has become an invaluable resource to people worldwide who seek information about celiac disease and the gluten-free diet.
In 1998 I created The Gluten-Free Mall, Your Special Diet Superstore! which was also another Internet first—it was the first gluten-free food site to offer a shopping cart-style interface, and the ability for people to order gluten-free products manufactured by many different companies at a single Web site.
I am also co-author of the book Cereal Killers, and founder and publisher of Journal of Gluten Sensitivity.
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”
To submit your comments to the docket by mail, use the following address:
The Division of Dockets Management
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:
- Questions and Answers on the Gluten-Free Labeling Proposed Rule:
- Consumer Update on the Gluten-Free Labeling Proposed Rule:
As always, Celiac.com welcomes your comments (see below).