The FDA last month released a regulation defining the term “gluten-free” for voluntary food labeling. The regulation sets a standard of no more than 20 parts per million of gluten for a product to be labeled as gluten-free, among other requirements.
The standard “is consistent with that set by other countries and international bodies that set food safety standards,” says Shelly Burgess, an FDA press officer. The 20 parts per million threshold follows the guidelines set by the 185-member-country Codex Alimentarius Commission and the European Commission “concerning the composition and labeling of foodstuffs suitable for people intolerant to gluten,” she says in an email.
Some consumers with celiac disease and other gluten sensitivities have objected to the standard, saying they experience reactions at exposure levels lower than 20 parts per million of gluten. However, support organizations for people with gluten intolerances, including the Celiac Disease Foundation and the Gluten Intolerance Group, have supported the FDA’s labeling rule.
“I do feel confident that it’s a safe standard,” Cynthia Kupper, RD, executive director of the Gluten Intolerance Group of North America, says in an interview. “The research shows that people have cellular changes or reactions that would be conducive to celiac disease at levels as low as 50 ppm, so the regulation is set to be so low that hopefully consumers would never reach that level.”
Some consumers have objected to the standard because they believe they are reacting to lower levels of gluten content, but this has not been borne out scientifically, Kupper says. “It can’t be proven that consumers are reacting to these foods [with gluten levels lower than 20 ppm], or that they are reacting to the gluten and not to something else in the foods,” says Kupper. “So it is hard to set a standard that’s even stricter if we can’t prove that it’s a problem.”
Marilyn Geller, chief executive officer of the Celiac Disease Foundation, said in a statement that the group’s medical advisory board agrees with the FDA’s assessment “that less than 20 ppm is the threshold level of gluten that is tolerated by those with celiac disease.”
“I recognize that there are individuals who do not support the new standard,” Geller’s statement continues. “I believe, however, that the FDA rule is a significant victory for our celiac and gluten-sensitive community…We should be delighted that the vast majority of consumers can finally be assured that food products labeled gluten-free are safe for consumption.”