FDA Proposes Rule to Define "Gluten-Free" for Voluntary Labeling Purposes
The Food and Drug Administration (FDA) has issued a proposed rule that would add a new section 101.91 to 21 CFR in order to define the term "gluten-free" for voluntary use in the labeling of foods. FDA has also issued a "Questions and Answers" document on the proposed rule.
Sign up for a free preview to unlock the rest of this article
Export Compliance Daily combines U.S. export control news, foreign border import regulation and policy developments into a single daily information service that reliably informs its trade professional readers about important current issues affecting their operations.
According to FDA, this proposed rule is in response to the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). Written or electronic comments on the proposed rule are due by April 23, 2007.
Proposed Definition of Claim "Gluten-Free"
Under the proposed rule, the claim "gluten free" (or a similar claim such as "free of gluten", "without gluten", or "no gluten") would mean that the food bearing the claim does not contain any of the following:
an ingredient that is any species of the grains wheat, rye, 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
- ppm or more gluten.
Food with "Gluten-Free" Claim that Fails to Meet Definition Would be Misbranded
FDA is proposing that a food that bears a "gluten-free" or similar claim in its labeling and fails to meet the conditions in the proposed definition would be deemed misbranded.
Food Bearing "Gluten-Free" Claim that is Inherently Free of Gluten (Except Oats)
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, unless the claim refers to all foods of that same type (e.g., "milk, a gluten-free food" or "all milk is gluten-free") and the food does not contain 20 ppm or more gluten.
For oats, the FDA is proposing that a food made from oats that bears a gluten-free (or similar) 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.
(The proposed rule would also define the term 'gluten' to mean the proteins that naturally occur in a prohibited grain and that may cause adverse health effects in persons with celiac disease (e.g. prolamins and glutelins).
According to FDA, 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.
- written or electronic comments due by April 23, 2007
FDA contact: Rhonda Kane (301) 436-2371
FDA proposed rule, D/N 2005N-0279, FR Pub 01/23/07, available at http://a257.g.akamaitech.net/7/257/2422/01jan20071800/edocket.access.gpo.gov/2007/pdf/E7-843.pdf
FDA Q&A (dated 01/23/07) available at http://www.cfsan.fda.gov/dms/glutqa.html