Update: FDA aims to publish final rule by Q3 2012; seeks public comments for next 60 days.
Update: During a teleconference about this announcement, the FDA said they are committed to moving quickly and project that a final rule will be published in the 3rd quarter of 2012, provided no other issues arise. The FDA also said they will likely outline a compliance program when they publish the final rule on gluten-free food labeling.
A recording of the teleconference is available through Sept. 2, 2011. See details on accessing the recorded teleconference.
The U.S. Food and Drug Administration (FDA) 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 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, according to an FDA press release. The threshold of less than 20 ppm also is similar to “gluten-free” labeling standards used by many other countries, the release also noted.
“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 from FDA: