• August 2, 2011

The U.S. Food and Drug Administration has 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 inviting comment on these additional data.

One criterion 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 less-than-20 ppm threshold is also consistent with the standard set by the Codex Alimentarius Commission in 2008, which has been adopted in regulations by the 27 countries composing the Commission of European Communities.

"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 [who cannot tolerate gluten] 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 agency is encouraging representatives 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

Comments can be electronically submitted to the docket at www.regulations.gov.