When may a label say “gluten free”? Get ready to comply with FDA’s final rule

FranCast Series


It is estimated that between 1.5 and 3 million people in America suffer from celiac disease, a chronic autoimmune disorder in which consuming gluten damages the lining of the small intestine, preventing absorption of nutrients. Celiac disease is incurable, but following a strict gluten-free diet can help manage symptoms and promote healing.  


In recent years, the number of food product labels containing the claim “gluten-free” has increased dramatically as manufacturers seek to target this market as well as the demands of health-conscious consumers.   However, while the Food and Drug Administration has had the authority to regulate these claims since 2004, manufacturers have been operating for many years without any uniform set of rules.


The FDA has now issued a long-awaited final rule which provides guidance for food manufacturers on use of the terms “gluten-free,” “no gluten,” “free of gluten” and “without gluten” in the labeling of foods.  The rule was issued under the  Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA), which  directed Secretary of Health and Human Services to define and permit use of the term “gluten-free” in food labeling.  The FDA initially published a proposed rule in 2007 and reopened the comment period in 2011.


When may a label say “gluten free”?


The final rule, issued August 5, 2013,  permits a “gluten-free” claim if any of the following criteria are met:

  • the food does not contain any gluten-containing grains, such as wheat, rye and barley
  • the food contains a gluten-containing grain that has been processed such that the presence of gluten in the food is less than 20 ppm  or
  • the food inherently does not contain gluten and any unavoidable presence of gluten in the food is below 20 ppm.  


In addition, if a food’s label includes the term “wheat” in the ingredient list or in a separate “contains wheat” statement and is also labeled “gluten-free,” then it must contain the following disclosure noted by an asterisk and in close proximity to the ingredient list or “contains wheat” statement:  “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”


Any food which bears a gluten-free claim will be considered misbranded if it does not meet the FDA requirements.  Additionally, although the FDA rule also does not define “low gluten” or “very low gluten,” the FDA discourages the use of statements about gluten levels other than “gluten-free” or the equivalent.   While the rule does not require any specific certification that foods comply with the gluten-free definition or that manufacturers use a particular test or methodology when complying with these requirements,  the rule indicates that the FDA will use a “scientifically valid method” to reliably detect the presence of 20 ppm of gluten in food.    Therefore, manufacturers will want to make sure they have adequate testing and quality control procedures in place to substantiate their claims.


When does the rule not apply?


It should be noted that the rule only applies when a manufacturer actually makes a gluten-free claim.   Nothing in the rule actually requires such a claim to be made or that a manufacturer disclose the exact amount of gluten contained in a food.


The final rule applies to all FDA-regulated foods, but excludes foods whose labeling is regulated by the US Department of Agriculture and the Alcohol and Tobacco Tax and Trade Bureau, such as most meats, poultry, certain egg products and most alcoholic beverages.  However, certain FDA-regulated beers which bear the claim “gluten-free” and are made from a non-gluten-containing grain or  made from a gluten-containing grain where the beer has been subject to processing to remove the gluten will be subject to the final rule.


Manufacturers have until 8/5/2014 to comply


The final rule represents a compromise among three factors: identifying a level of gluten that is safe for most individuals with celiac disease; creating consumer labeling that is clear and understandable; and avoiding burdens on food manufacturers which could increase the price of gluten-free foods or discourage manufacturers from marketing foods with a “gluten-free” label entirely.


The final rule became effective on September 4, 2013.  However, manufacturers will have until August 5, 2014 to comply with the rule.  The federal rule preempts any different or conflicting state law or regulation.


If you have questions about the final gluten-free rule or would like to have labels reviewed for compliance with the final rule, please contact Scott W. Pink.




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