"Gluten-Free" Claims – FDA Publishes Final Rule

The Food and Drug Administration (FDA) has published a final rule that defines the term “gluten-free” and deems misbranded any use of such a claim or related claims on foods that do not meet the definition.[1]  The final rule creates new 21 CFR 101.91 in Subpart F—Specific Requirements for Descriptive Claims that are Neither Nutrient Content Claims or Health Claims. 

Definition of a “Gluten-Free” Food

FDA states that the claim “gluten-free” can be used on the labeling of foods that do NOT contain:

• an ingredient that is any species of the grains wheat, rye, barley, or a crossbred hybrid of these grains (all noted grains are collectively referred to as “gluten-containing grains”);
• an ingredient that is derived from a gluten-containing grain and that has not been processed to remove gluten (e.g., wheat flour); or
• an ingredient that is derived from a gluten-containing grain and 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; or
• 20 ppm or more of gluten.

Except for the use of the phrase “gluten-containing grains” in place of “prohibited grains”, this definition is the same as that proposed in 2007.

Under the final rule, any food bearing a “gluten-free” claim that fails to meet the conditions in the definition will be deemed misbranded in violation of the Federal Food, Drug, and Cosmetic Act.  In the final rule, the claims “no gluten,” “free of gluten,” and “without gluten” are considered equivalent to a “gluten-free” claim and are only permitted if they meet the definition above.  Also, states are preempted from defining “gluten-free” or a similar claim that differs from the FDA definition.  Finally, we note that FDA discourages the use of any claim related to gluten content other than “gluten-free”.

Foods Inherently Free of Gluten

The final rule differs from the proposed rule regarding “gluten-free” claims on food inherently free of gluten.  FDA had proposed to deem misbranded a food bearing a “gluten-free” claim if the food is inherently free of gluten but does not refer to all foods of that same type (e.g., “milk, a gluten-free food”).  However, in response to numerous comments from industry, the final rule permits use of a “gluten-free” claim without reference to foods of the same type.  The final rule reflects FDA’s understanding that in many instances, “it would be misleading to suggest that a particular food or food category is always gluten-free,” as certain foods of the same type may be available in variations (e.g., flavored and unflavored) that may contain gluten and “cross-contact with gluten-containing ingredients can and does occur in virtually any facility where gluten-containing ingredients are present.”  

Foods that Declare “Wheat” and are also “Gluten-Free”

The final rule adds a requirement that food whose labeling includes the term “wheat” in the ingredients list or in a separate “Contains wheat” statement and also bears the claim “gluten-free” must also bear additional language clarifying that the wheat has been processed to allow the food to meet FDA requirements for a “gluten-free” claim as follows: 

“The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.” 

The statement should appear in close proximity to the ingredient declaration and be linked to the declaration of “wheat” in the ingredient declaration or “Contains wheat” statement by an asterisk (or other symbol).  

Fermented or Hydrolyzed Foods/Ingredients

FDA intends to issue a proposed rule to address its compliance approach to foods that are, or contain ingredients that are, fermented or hydrolyzed.  The issue is that gluten content of fermented and hydrolyzed foods cannot be reliably measured pursuant to 21 CFR § 101.91(c) because currently available sandwich ELISA-based methods are not effective in detecting and quantifying intact gluten proteins in these foods.  Until FDA establishes provisions specifically for these foods, a “gluten-free” claim will be permitted on such foods, provided the food meets all of the requirements for bearing a “gluten-free” claim.  Until the separate rule on “gluten-free” labeling of hydrolyzed and fermented foods is issued, FDA intends to exercise enforcement discretion with respect to the requirements for “gluten-free” labeling for FDA-regulated beers that currently make a “gluten-free” claim and that are: (1) made from a non-gluten-containing grain or (2) made from a gluten-containing grain, where the beer has been subject to processing that the manufacturer has determined will remove gluten below a 20 ppm threshold. 

Please let us know if you have any questions regarding FDA’s final regulation on “gluten-free” claims.