On August 5, 2013, the U.S. Food and Drug Administration (FDA) issued its much anticipated and long-awaited Final Rule on the “Gluten-Free Labeling of Foods”—more than six years after the Agency published its Proposed Rule in January 2007. The final rule was issued under the authority of the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) and defines the term “gluten-free” for voluntary use in the labeling of foods, setting forth conditions on the use of the term. The final rule seeks to answer many of the lingering questions from both food manufacturers and those consumers who suffer from celiac disease, by establishing a standardized federal definition of the term “gluten-free” across the food industry. Although the final rule becomes effective on September 4, 2013, companies will have one year to comply with the regulation until August 5, 2014.

Under newly added 21 C.F.R. §101.91(a)(3), the labeling claim “gluten-free” means that any food bearing the claim in its labeling:

  • does not contain an ingredient that is a gluten-containing grain (e.g. wheat, rye, barley or any of their crossbred hybrids);
  • does not contain an ingredient derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour);
  •   does not contain an ingredient derived from a gluten-containing grain that has been processed to remove gluten if use of that ingredient results in the presence of > 20 ppm of gluten in the food.
  • does not contain 20 ppm or more gluten.

The final rule allows voluntary “gluten-free” claims—including “no gluten,” “free of gluten” or “without gluten” claims—on any food that meets the aforementioned requirements. Any food bearing a gluten-free claim that does not meet these requirements will be deemed misbranded.

The 20 ppm threshold remained unchanged from the original proposed rule and is consistent with other FDA-regulated labeling claims (e.g., “fat-free” or “sugar-free”) that allows for the presence of small specified amounts of the nutrient. More notable are the proposals from the 2007 proposed rule that were left out of the final rule. Specifically, the final rule permits gluten-free claims without any qualifying language for any foods that are inherently gluten-free as long as any unavoidable presence of gluten falls below the 20 ppm threshold. In the 2007 proposed rule, FDA proposed to deem misbranded any food bearing a gluten-free claim if the food is inherently free of gluten and the claim does not refer to all foods of the same type (e.g., “milk, a gluten-free food” or “all milk is gluten-free”), but citing the confusion that might ensue, FDA excluded this provision.

Additionally, FDA determined that other qualifying language in conjunction with a gluten-free claim was unnecessary, including any potential clarification that a food bearing a gluten-free claim may potentially contain small traces of gluten (but always less than 20 ppm). This is significant because manufacturers no longer need to worry about gluten cross-contact, as long as the unavoidable presence of gluten due to cross-contact situations or migration from packing/processing materials does not exceed the 20 ppm threshold.

The final rule provided for only one scenario where manufacturers would be required to include specific clarifying language. 21 C.F.R. §101.3(b)(3) states that any food that lists “wheat” in the ingredient list or includes a “contains wheat” statement (as required under FALCPA) and also bears a gluten-free claim will be misbranded unless the word “wheat” or the “contains wheat” statement are immediately followed by an asterisk that directs the consumer to the following disclaimer: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”

Very few of the other proposals in the 2007 proposed rule were included in the final rule. For example, FDA declined to define the terms “low-gluten,” “very-low gluten” or other tiered labeling claims because the Agency determined that there was no scientific basis for these claims. Additionally, the final rule specified no technical requirements for gluten-free labeling statements, including size, conspicuousness or placement of the statement. FDA also explicitly declined to establish the use of any universal symbol, logo or standardized print format to identify a gluten-free food.

According to the final rule, preemption may arise if a state or local requirement is found to obstruct the federal purpose of the rule, but state or local requirements are only preempted to the extent that they are different from the rule’s requirements. In order to ensure that consumers—particularly those that suffer from celiac disease—have confidence to identify and purchase gluten-free products, state requirements could not change the 20 ppm threshold or otherwise establish different requirements related to the use of the terms “gluten-free,” “no gluten,” “free of gluten” or “without gluten.” However, this does not mean that additional state or local labeling requirements or warning statements would be preempted. For example, a state could require a statement about the health effects of gluten consumption on persons with celiac disease or information regarding processing methods.

Preemption has proven to be a thorny issue in the past for other similar labeling claims. There exist other FDA regulations that allow manufacturers to round down nutrient values to zero, despite the presence of small amounts of the nutrient (e.g., if a serving contains less than 0.5 g of trans fat, the content, when declared, can be expressed as zero). This has prompted several state law suits that argue labeling claims such as “0 g Trans Fat” are inherently misleading to consumers when, in fact, the product contains some trans fat. Similar issues may also arise around “gluten-free” labeling claims, where products do, in fact, contain small traces of gluten (but less than 20 ppm). Although the final rule establishes a federal limit of 20 ppm, there are no assurances that all gluten-related state claims will be preempted by this new federal law.

Although the final rule will be effective in one month, as noted above manufacturers will have one year to comply with the rule, until August 5, 2014.