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.
U.S. Senators Ron Wyden (D-OR) and Patrick Leahy (D-VT) sent their letter to FDA Commissioner Dr. Margaret Hamburg asking for an explanation for the delay.
They wrote: “We ask that you provide us with an update on when FDA will promulgate a final rule, why FDA has taken so long to issue this rule, and if there are any legal or regulatory hurdles that have prevented the timely implementation of this legislation.”
Greater awareness of celiac disease – an autoimmune disorder with symptoms triggered by consumption of gluten, a protein found in wheat, rye, barley and spelt – has led to more people being diagnosed, and the only treatment currently available is complete avoidance of gluten.
The introduction of FALCPA labeling regulations mandating the labeling of gluten aimed to make this easier for those with gluten sensitivity, but research has suggested that consumers are confused by the wide variety of advisory labels as organizations have developed their own standards.
“The regulatory uncertainty surrounding FDA’s inaction has led to a proliferation of ‘gluten free’ standards and labels provided by 3rd party groups. This creates confusion for consumers, and hesitancy amongst producers on what their requirements will be.” Senators Wyden and Leahy wrote.
Most recently, Quality Assurance International (QAI) and the healthcare nonprofit National Foundation for Celiac Awareness (NFCA) created a “Certified Gluten-Free” label with a tolerable upper threshold of 10ppm. The organizations released the certification scheme last month, and claim that it is independent and science-based, verified through inspections and product testing.
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 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 country suffer from celiac disease, yet only around 40,000 to 60,000 Americans have been diagnosed.