Whew! “Gluten-Free” Claim Threshold Remains 20 ppm

By Ricardo Carvajal –

FDA published a final rule implementing the directive in the Food Allergen Labeling and Consumer Protection Act ("FALCPA") to define the term “gluten-free” (and other terms that FDA regards as equivalent, namely “no gluten,” “free of gluten,” and “without gluten”).  The threshold for use of the claim will be 20 ppm – the same as was specified in the proposed rule.  There was some uncertainty as to whether the threshold would remain unchanged, given that FDA’s safety assessment estimated a level of concern for individuals with celiac disease of less than 20 ppm.  FDA explained its decision in part as follows:

In sum, defining the term "gluten-free" for use in the voluntary labeling of food involves the consideration of multiple factors, including currently available analytical methods and the needs of individuals with celiac disease, as well as factors such as ease of compliance and enforcement, stakeholder concerns, economics, trade issues, and legal authorities. An important consideration is that, as the comments suggest, lowering the gluten level below 20 ppm will make it far more difficult for manufacturers to make food products that could be labeled as "gluten-free," thereby reducing food choices for individuals with celiac disease. While the safety assessment results suggest that there may be some individuals with celiac disease who are highly sensitive to gluten exposure even at very low levels, the safety assessment, by its nature, may lead to a conservative, highly uncertain estimation of risk for these individuals. Given the various factors we have to consider and the data available to us, we decline to revise the rule to adopt a safety assessment-based approach at this time.

As did the proposed rule, the final rule keeps oats off the list of “prohibited grains” – referred to in the final rule as “gluten-containing grains” – so that the presence of oats will not in and of itself disqualify a food from being eligible for a “gluten-free” claim.  However, FDA encourages manufacturers “to indicate in their labeling that an oat-derived ingredient is present” if the food uses an oat-derived ingredient and the word “oat” does not appear in the ingredient list (FDA gives the example of beta glucans). 

The final rule continues to exclude from eligibility finished foods that have been processed to reduce gluten below the threshold.  FDA plans to issue a proposed rule addressing foods that “are, or contain ingredients that are, fermented or hydrolyzed.”  In the interim, FDA intends to exercise limited enforcement discretion with respect to FDA-regulated beers 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.”

The final rule includes some significant modifications.  For example, foods that inherently do not contain gluten may use the "gluten-free" claim without a qualifying statement indicating that the food does not ordinarily contain gluten, provided that the food contains less than 20 ppm gluten.  As an additional example, a food will be deemed misbranded if bears a gluten-free claim and also includes the term "wheat" in the ingredient list or in a separate "contains wheat" statement as required under FDCA § 403(w), unless the word "wheat" is linked by an asterisk to a disclaimer “in close proximity to the ingredient statement” that states: "The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods."

Finally, State or local requirements are preempted “to the extent that they are different from” the rule’s requirements, or to the extent that they obstruct the purpose of achieving national uniformity with respect to the use of those terms.  However, other State or local requirements would be permissible (e.g., “a State would not be preempted from requiring a statement about the health effects of gluten consumption on persons with celiac disease or information about how the food was processed”).

The compliance date for the final rule is August 5, 2014.