FDA Defines Details on Gluten-Free Labeling

FDA is proposing to define the term gluten-free for voluntary use in the labeling of foods, to mean that the food does not contain any of the following: an ingredient that is any species of the grains wheat, rye or barley, or a crossbred hybrid of these grains (all noted grains are collectively referred to as prohibited grains); an ingredient that is derived from a prohibited grain and that has not been processed to remove gluten (e.g., wheat flour); an ingredient that is derived from a prohibited grain and that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food; or 20 ppm or more gluten. A food that bears the claim gluten-free or similar claim in its labeling and fails to meet the conditions specified in the proposed definition of gluten-free would be deemed misbranded.

FDA also is proposing to deem misbranded a food bearing a gluten-free claim in its labeling if the food is inherently free of gluten and if the claim does not refer to all foods of that same type (e.g., milk, a gluten-free food or all milk is gluten-free). In addition, a food made from oats that bears a gluten-free claim in its labeling would be deemed misbranded if the claim suggests that all such foods are gluten-free or if 20 ppm or more gluten is present in the food.

FDA notes that establishing a definition of the term gluten-free and uniform conditions for its use in the labeling of foods is needed to ensure that individuals with celiac disease are not misled and are provided with truthful and accurate information with respect to foods so labeled. This proposed action is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA).

Interested parties can submit written or electronic comments now through April 23, 2007, either electronically via the Federal eRulemaking Portal at http://www.regulations.gov or the agency website at http://www.fda.gov/dockets/ecomments, faxed to 301/827-6870, or sent to Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. To ensure timely processing of comments, FDA is no longer accepting comments submitted to the agency by e-mail. FDA encourages people interested in submitting comments electronically to use the Federal eRulemaking Portal or the agency website. For access to the docket to read background documents or comments received, go to http://www.fda.gov/ohrms/dockets/default.htm and insert the docket number (fr23ja07-10) into the Search box and follow the prompts and/or visit the Division of Dockets Management, 5630 Fishers Lane, Room 1061, Rockville, MD 20852. For more information, contact: Rhonda R. Kane, Center for Food Safety and Applied Nutrition (HFS-820), Food and Drug Administration, 5100 Paint Branch Pkwy., College Park, MD; 301/436-2371; fax: 301/436-2636; e-mail: [email protected].

To read the Jan. 23 Federal Register entry on this subject, see http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/E7-843.htm.