FDA Reopens Comment Period on Gluten Labeling

WASHINGTON -- A final decision on the FDA's proposed regulation governing the labeling of foods as gluten-free will await more comments, the agency announced.

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 of gluten, the FDA said Tuesday in a press release.

The agency is also asking for comments on a safety assessment of exposure to gluten for people with celiac disease -- an estimated 1% of the population.

The 20-ppm standard is based in part on the current methods for gluten detection -- validated methods cannot reliably detect lower amounts.

The standard has already been adopted in regulations by the 27-nation 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," Michael Taylor, deputy commissioner for foods, said in the release.

"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 comment docket on this rule opened at noon on Wednesday and will remain open for 60 days.

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