FDA Issues Guidance on Gluten–Free Labeling Requirements

As American consumers become increasingly more heath conscious, many more of them now read the labels on food packages to determine the overall fat content, percent of calories from carbohydrates, the presence of trans fats, and generally to ascertain the ingredients in prepared foods. One of the growing concerns is the presence of gluten in many prepared foods. Gluten is a protein found in wheat, barley, and rye. Gluten also shows up in many whole grain foods related to wheat, including bulgur, farro, kamut, spelt, and triticale (a hybrid of wheat and rye). Many people have been advised by their doctor or nutritionist to avoid gluten as much as possible, as it can cause, among other things, allergic reactions and gastric distress. Recognizing that Americans needed to be able to discern the gluten content in prepared foods, over a year ago the Food and Drug Administration (FDA) published a final rule establishing a regulatory definition of the term “gluten-free” for voluntary use in the labeling of foods. The intent of the final rule is to provide a uniform definition of the term “gluten-free” so that consumers, especially those who have celiac disease and must follow a strict gluten-free diet, will be better able to make informed purchasing decisions when they see the phrase “gluten-free” on the labeling of food.          

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

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

•  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 (such as wheat flour) that has not been processed to remove gluten; or

•  An ingredient that is made from a gluten-containing grain that has been processed to remove gluten, if the use of that ingredient results in 20 parts per million (ppm) or more of gluten in the finished food. 

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

Unlike many other regulations, there are no rules regarding the color, type size, or placement of the “gluten- free” claim on the product’s packaging. 

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 is likely a good idea to do so. Failing to ensure that the food item bearing the voluntary “gluten-free” label 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, such as:

•  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.

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. However, it will undoubtedly find its way into use as a standard in the industry, including in the growing area of food-labeling litigation. Producers and retailers of food products will be wise to become familiar with the regulations, as it may be easier to prove mislabeling claims against them in light of the new guidance if a food product contains more gluten than is allowed. Conversely, producers and retailers may be able to defend themselves more readily against such claims if their food products comply with the FDA’s recently released guidance.

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