The Food and Drug Administration (FDA) has reopened comments on its proposed thresholds for gluten traces in products labeled as gluten free – four years after it originally proposed the guidelines.
Defining a tolerable threshold level for gluten presence in gluten-free foods was included as part of the Food Allergen Labeling and Consumer Protection Act (FALCPA) of 2004. In 2007, the FDA proposed that gluten should be labeled at anything over 20mg per kg (20ppm); foods labeled gluten-free containing more than this amount would be considered misbranded. Many companies are already voluntarily using this standard, but the rule has yet to be finalized.
Deputy commissioner for foods Michael Taylor said: “Before finalizing our gluten-free definition, we want up-to-date input from affected consumers, the food industry, and others to help assure that the label strikes the right balance. We must take into account the need to protect individuals with celiac disease from adverse health consequences while ensuring that food manufacturers can meet the needs of consumers by producing a wide variety of gluten-free foods.”
In a conference call on Tuesday, celiac expert Dr. Alessio Fasano of the Center for Celiac Research at University of Maryland said he considered that the 20ppm threshold would be a safe level for those with celiac disease. The FDA also said that it would make available the scientific research indicating the safety of the 20ppm threshold on its website.
The proposed rule is also in line with international regulation on labeling thresholds for gluten in gluten-free foods. In Europe, the Codex Commission approved 20ppm as an accepted threshold for gluten in gluten-free products in 2008, in the first update to guidelines since 1983. The limit was hugely cut from 200ppm to 20ppm – and it also claims this level is considered to pose no risk to celiac sufferers. It said that the reason for the change is that low levels are more easily attainable than 25 years ago due to technological advances allowing for more accurate detection of minute gluten traces.
The US government estimates that around one in 133 people in the United States suffers from celiac disease, an autoimmune disorder with symptoms triggered by consumption of gluten, the protein found in wheat, rye, barley and spelt – yet only around 40,000 to 60,000 Americans have been diagnosed.
The move to reopen the proposal for comments comes just weeks after two US Senators, Ron Wyden (D-OR) and Patrick Leahy (D-VT), sent a letter to FDA commissioner Margaret Hamburg urging prompt action on gluten-free labeling laws and an explanation for the delay.
Comments and suggestions about gluten-free labeling can be made online at www.regulations.gov , citing docket number FDA-2005-N-0404.