Over the past several years, consumers have no doubt seen an increase in “gluten-free” representations on food labels and restaurant menus. But what does “gluten-free” really mean and why is it important? After years of research and public comment, the U.S. Food and Drug Administration will finally weigh in on the issue. Its proposed “gluten-free” label requirements are currently under review by the White House, with final action expected later this month.

Gluten, a naturally occurring protein in wheat, rye, and barley (and some crossbred hybrids of these grains) can wreak havoc on the digestive systems of those who suffer from celiac disease (CD) and other gluten sensitivities or allergies. When they ingest gluten-containing products, an abnormal immune response is triggered, causing production of antibodies that attack the lining of the small intestine. This can lead to various symptoms, including abdominal pain, bloating, vomiting, and general intestinal discomfort. Failure to adhere to a strict gluten-free diet may increase the risk of related conditions, such as autoimmune disorders, liver disease, and infertility.

The FDA’s proposed rule sets a 20-parts-per-million threshold for labeling products “gluten free.” Under the rule, foods claiming to be gluten-free must contain 20 parts per million or less of gluten. The agency based its proposal, in part, on currently available methods for detecting gluten, which are unreliable below this level. In addition, the 20-parts-per-million threshold is consistent with the standard set by the Codex Alimentarius Commission, which has been adopted as the controlling standard by many countries throughout the European Union.

The proposed rule, which has been the subject of much debate and comment, may be a welcome development for both consumers and food producers alike, who, in the absence of any FDA regulation or guidance, have been left uncertain as to what properly (and safely) qualifies as “gluten-free.” Check back with us for more up-to-date developments on implementation and enforcement as the FDA’s new “gluten-free” regulations take effect.