FDA regulations to make gluten-free claims went into effect in August 2014. Our gluten and allergen expert, Diane Moyer, MS, RD, has summarized rules for making gluten-free claims.

Criteria for Gluten-Free Claims

For a food to be labeled “gluten-free” it must meet the following criteria:

1. The food must be inherently gluten-free, such as unaltered fruits, vegetables, dairy, and meat.
2. The food must be free of the gluten-containing grains defined as wheat, barley, rye, spelt, and crossbreeds of those grains (Kamut, triticale, etc.).
3. If gluten is present in the food due to cross-contact from the manufacturing process, the food must contain less than 20ppm (parts per million) of gluten.
4. The food may not contain any ingredient derived from a gluten-containing grain, even if the food tests to less than 20ppm. (See number 5 for an exception to this rule.) 
5. The food may contain a gluten-containing grain that has been processed to remove the gluten AND the final product contains less than 20ppm. Gluten-free wheat starch is one ingredient that would be OK to include under this section if the end product contains less than 20ppm of gluten. However, this could lead to the confusing situation of food being labeled “gluten-free,” and, at the same time, stating “contains wheat,” which is required under the food allergen labeling law.

Acceptable Terms for Gluten-Free Claims

Using the term “gluten-free” on a label is voluntary by food manufacturers. Foods without this label will not necessarily be any less safe. The terms “no gluten,” “free of gluten,” or “without gluten” are identical to “gluten-free” and subject to the same regulations. On the other hand, statements such as “made with no gluten-containing ingredients” will continue to be allowed, but unless the food also states “gluten-free,” it cannot be assumed the food meets all the above criteria.

Testing for Gluten

Food manufacturers are not required to test their products for gluten. However, they are expected to use quality control measures to ensure that gluten-free guidelines are met. Food manufacturers might contract with a third party or a national gluten-free certifying organization to test their products. Ingredient suppliers would be subject to the same scrutiny. Ultimately food manufacturers are responsible for ensuring claims used on their labels are truthful and compliant with the regulations.

Oats and Gluten-Free Claims

Oats are not considered a gluten-containing grain under FDA regulations, even though a minority of people with Celiac Disease and gluten-related disorders react to oats. However, most oats have cross-contact with wheat and barley from the fields and mills, so including them would make it difficult to reach the 20ppm goal. There are certified gluten-free oats that have been grown and milled separately from other grains.

Restaurants Making Gluten-Free Claims

Although the FDA does not address restaurants in the regulations, they are expected to follow the same guidelines if using a gluten-free claim. In restaurants that prepare gluten-containing foods, especially if any baking is done on the premises, there is a high likelihood of cross-contact of other foods. Therefore, it might be advisable, for liability purposes, for restaurants to use alternative wording to “gluten-free” in identifying these options on the menu.

More Information on Gluten-Free Claims

Gluten-Free Labeling of Foods

Questions and Answers on the Gluten-Free Food Labeling Final Rule