The Food and Drug Administration’s (FDA’s) proposed regulation defining the term “gluten-free” for food-labeling purposes has at last reached the White House for final approval. Approval by the White House Office of Information and Regulatory Affairs (OIRA) would conclude a regulatory process that began in 2005 in an effort to protect consumers who suffer health-threatening reactions to gluten, a protein in grains and found in such everyday foods such as bread and pasta.

Though harmless to most individuals, gluten -- a protein found in wheat, rye, and barley -- causes intestinal damage to people with celiac disease (CD). The National Institutes of Health estimates that CD affects as much as 1 percent of the U.S. population. For individuals with the disease, gluten consumption can cause abdominal pain, bloating, and vomiting and can lead to serious health problems such as anemia, osteoporosis, diabetes, and intestinal cancer. The only treatment for CD is strict adherence to a gluten-free diet, and the absence of labeling regulations has caused confusion for consumers seeking to purchase gluten-free foods, and uncertainty for food manufacturers seeking to provide gluten-free labeled products.

Under the agency’s proposed regulation, a food may be labeled “gluten-free” if it contains less than 20 parts per million (ppm) gluten.  The < 20 ppm standard is based in part on the lowest level at which currently available test methods can reliably detect gluten (although FDA has indicated in a Q&A document that it would be open to reconsidering the threshold if more sensitive methods become available). It is also consistent with the 20 ppm standard adopted by the European Union.

FDA first proposed its definition in January 2007. After years passed without any further rulemaking, and in the face of mounting criticism including by two US senators,FDA re-opened the proposed rule to public comment in August 2011. Simultaneously, the agency invited comment on its study of the adverse health effects of gluten exposure to individuals with CD, which found that a 0.01 ppm threshold would be protective of even the most highly sensitive individuals. As explained in the proposed regulation, FDA concluded that the study should not be used to define “gluten-free” because “the estimation of risk to individuals with celiac disease associated with very low levels of gluten exposure may be conservative and highly uncertain.”  FDA expressed concern that a threshold lower than < 20 ppm could cause food manufacturers either to label fewer foods as gluten-free or raise the price of foods so labeled, thereby making it harder for people with CD to adhere to a gluten-free diet.

The proposal received thousands of comments, including those in support of the < 20 ppm standard, some that urged a lower threshold, and others that weighed in on the test methods that FDA proposes to use to assess compliance for foods bearing “gluten-free” labels. 

The proposed rule is now with OIRA for final approval before it can be enacted.  The rule has been deemed “economically significant,” meaning that it is expected to have annual impact on the economy of $100 million or more.  While this designation may prioritize review of the rule, it may also invite greater scrutiny.