Gluten refers to specific proteins (e.g. glutelins and prolamins) that are naturally found in gluten-containing grains. For some, especially those with celiac disease, these proteins can cause serious health effects. The Food and Drug Administration (FDA) published the final rule for voluntarily labeling foods as gluten-free in 2013, and compliance to this rule has been required since August 5, 2014. The FDA defines gluten-free as a food that is naturally gluten free; or does not contain an ingredient that is: “1) a gluten-containing grain (e.g., spelt wheat); 2) derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or 3) derived from a gluten-containing grain 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”. Additionally, any gluten in the food that cannot be avoided during processing must be less than 20 ppm.
The gluten-free labeling rule is voluntary for all packaged foods that are regulated by the FDA. The rule does not include foods regulated by the USDA, such as meat, poultry and some egg products; and foods and beverages regulated by the Alcohol and Tobacco Tax and Trade Bureau, which includes alcoholic beverages and products that contain more than 7% or more alcohol by volume.
Gluten-free labeling is not required on gluten-free products. The rule is voluntary; therefore it is the manufacturer’s decision whether to label their products that are gluten-free. The rule does apply to all FDA regulated and labeled foods no matter if they are produced domestically in the United States or imported from another country.
How to Ensure Foods are Gluten Free
Manufacturers need to have a practice in place to ensure that all gluten-free labeled products meet the regulations of the rule. Methods to ensure these products contain less than 20 ppm of gluten include:
- Performing a gluten test at the manufacturing facility of either starting ingredients or the finished product.
- Enlisting a third-party laboratory to conduct gluten testing.
- Requesting certificates of gluten analysis from the suppliers of the ingredients used in the product.
- Participating in a gluten-free certification program.
The FDA is responsible for monitoring all food products that are labeled as gluten-free to ensure they are in compliance with the rule. Methods of monitoring include sampling of the product, inspections of the manufacturing facility, reviews of the food label, following up on any consumer or industry complaints that are reported, and gluten testing.
This rule defines the claim “gluten-free”. Other terms that can be used in place of “gluten-free” include “no gluten”, “free of gluten”, or “without gluten” as long as these terms meet all of the FDA’s requirements for “gluten-free” claims. Because the FDA does not specifically define these terms in the rule, they discourage their use. Other terms that the FDA discourages the use of include “low gluten” and “very low gluten”. Any foods with these claims will be evaluated to determine if the claim is truthful and not misleading to the consumer.
Foods that are naturally gluten-free, such as bottled water or fruits and vegetables, can be labeled as gluten-free. Non-gluten containing grains such as rice, buckwheat and oats, can be labeled as gluten-free as long as any potential cross contact with gluten containing products results in the gluten-free grain having less than 20 ppm gluten.
The FDA does not have a required gluten-free logo or symbol. The manufacturer may place the gluten-free claim anywhere on a food label as long as it does not interfere with the information that is mandatory on the label.
Gluten testing can be performed at Clemson University through the Food2Market program. Please visit the program’s website for more information on product testing at www.clemson.edu/extension/food2market. Please notify Food2Market staff before sending in products for gluten testing so that testing supplies can be ordered in advance of your samples arriving.