Nearly a year ago on August 5, 2013, we reported on the blog that the Food and Drug Administration (FDA) had published a final rule establishing a regulatory definition of the term “gluten-free” for voluntary use in the labeling of foods. The final rule is intended to provide a uniform definition of the term “gluten-free” so that consumers, particularly those who have celiac disease, will know what it means when they see it on the labeling of food.

The rule became binding and effective on September 4, 2013, but August 5, 2014 is the date when FDA-regulated foods labeled “gluten-free” must comply with all requirements established by the final rule. In preparation of the upcoming compliance date, FDA prepared a Small Entity Compliance Guide which restates in plain language the requirements concerning use of the term “gluten-free” in the labeling of foods.

Specifically, the guidance states that any label claiming that a food is “gluten-free” must not contain any of the following ingredients:

  • An ingredient that is a gluten-containing grain (such as wheat, rye, or barley or any of their crossbreeds); or
  • An ingredient that is made from a gluten-containing grain and that has not been processed to remove gluten. For example, “wheat flour” is an ingredient made from wheat that has not been processed to remove the naturally occurring gluten in wheat. Therefore, wheat flour cannot be used as an ingredient to make a food labeled “gluten-free;” or
  • An ingredient that is made from a gluten-containing grain and that has been processed to remove gluten, if the use of that ingredient contains 20 parts per million (ppm) or more gluten.

The claim can also appear on the labels of foods that inherently do not contain gluten, such as fresh vegetables or juices.

Another important bit of information is that, unlike other required label components, there are no requirements for color, type size or placement of the “gluten- free” claim.

Although the rule does not expressly require manufacturers to test for the presence of gluten in the raw ingredients or finished foods labeled “gluten-free,” it might be wise to do so. Failing to ensure that the food item bearing a “gluten-free” claim meets the requirements of the rule could cause the product to be deemed misbranded and thus subject to FDA regulatory action. In its guidance, the agency encourages companies to use effective measures to ensure that any foods labeled as “gluten-free” comply with the requirements including:

  • testing the ingredients to determine their gluten content;
  • requesting certificates of gluten analysis from ingredient suppliers; or
  • participating in a third-party gluten-free certification program.

However, as with all agency guidance, FDA’s compliance guidance for gluten-free labeling does not establish legally enforceable responsibilities. Instead, this guidance describes the agency’s current thinking on a topic and should be viewed only as a recommendation. If you have any questions about gluten-free labeling or other food label claims, contact Stoel Rives label compliance experts Claire Mitchell and Anne Glazer.