In 2013 the Food and Drug Administration (FDA) established a rule requiring gluten-free food manufacturers to follow guidelines for the labeling of gluten-free products, making life for people with celiac disease a little easier. August 2014 was the deadline for manufacturers to bring the products into compliance with the characteristics of “gluten-free” food set out by the FDA, which includes having a level of less than 20 parts per million (ppm) or .002 percent gluten content.
In October 2017, the FDA published A Conversation with Carol D’Lima and Alessio Fasano on the impact of the voluntary gluten-free labeling standard since 2014. Carol D’Lima, PhD, is a food technologist in the FDA’s Office of Nutrition and Food Labeling, and Alessio Fasano, MD, is chief of Pediatric Gastroenterology and Nutrition and director of the Center for Celiac Research and Treatment at Massachusetts General Hospital. (Excerpts from the article are included below with kind permission from the FDA Health Communications office.)
Collective Effort by Celiac Groups
Dr. D’Lima noted that the push for gluten-free labeling began much earlier, with a provision of the Food Allergen Labeling and Consumer Protection Act of 2004, calling for the creation of the definition of gluten-free on food labels. “FDA reviewed the available science, including analytical methods, and used additional input from the food industry and celiac disease organizations to determine appropriate gluten tolerance levels and the best approach to defining the term ‘gluten-free,’” said Dr. D’Lima.
Dr. Fasano’s celiac center was instrumental in the sustained push to keep the resolution of the gluten-free definition on the FDA’s agenda, helping to coordinate the effort from celiac groups and individuals. Fasano traveled to Capitol Hill several times to provide expert testimony before the U. S Senate Committee on Health, Education, Labor, and Pensions, chaired by Sen. Ted Kennedy (D-Mass), until his death in 2009. Dr. Fasano writes in his book, Gluten Freedom, “Without his (Kennedy’s) visionary commitment, celiac disease today would still be without proper recognition in the legislation regulating appropriate thresholds of gluten intake.”
Dr. Fasano emphasized the importance of the celiac community in getting the gluten-free labeling rule established in 2013. “The celiac community is very tight, and they followed this process every step of the way over the course of 10 years of meetings and public forums,” said Dr. Fasano. “This is a classic example of how it sometimes takes a village to make things happen.”
World’s Tallest Gluten-Free Cake
Another vital player in that tight-knit village effort was Jules Shepard, gluten-free flour manufacturer, safe food activist, author and blogger. She recalls the controversy over the standard for testing when some proponents were pushing for 0 ppm as a standard. “We needed a standard for testing, and a 0 ppm isn’t practical,” recalls Ms. Shepard. To support the effort, she led a drive for 10,000 petition signatures supporting the 20 ppm standard backed by Dr. Fasano and other international experts.
“To move that through the FDA, we had to get their attention somehow,” says Ms. Shepard. She worked with others to hold The Gluten-Free Food Labeling Summit in May 2011, which featured an 11-foot, one-ton gluten-free cake to draw attention to the issue. The cake and the efforts of the group were featured in The Washington Post, USA Today and Forbes. Michael Taylor, former FDA Deputy Commissioner for Foods and Veterinary Medicine, attended the summit and consequently expedited the agency’s efforts, offering a draft gluten-free food labeling rule within three months of the summit.
“Consumers feel much more confident in the products they buy these days.”
Before the establishment of the gluten-free labeling rule, the lack of certainty about food ingredients was “the most stressful and worrisome issue that people with celiac disease were facing,” said Dr. Fasano. The FDA analyzed 702 samples from 250 products labeled “gluten-free” earlier this year; only one failed to comply with FDA requirements.
Dr. D’Lima noted that “Consumers feel much more confident in the products they buy these days.” But Dr. D’Lima, Dr. Fasano and Ms. Shepard all urge consumers to keep reading labels and remain vigilant against cross-contact, the accidental contamination of gluten-free food with gluten.
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