Strong compliance with gluten-free labeling could free FDA to focus more on cross contamination risk

“Cross contact,” which occurs when gluten-containing food comes in content with gluten-free products, “has always been important and is addressed in the gluten-free final rule” that was published in 2013 and went into effect Aug. 5, 2014, Carol D’Lima, a food technologist in FDA’s Office of Nutrition and Food Labeling, said in a question and answer post published on the agency’s website this month. Responding to a question about whether the agency’s focus would now shift to the dangers of cross contact, D’Lima explained that the gluten free final rule limits gluten due to cross contact to less than 20 ppm in a food labeled as gluten free. She added: “We have an ongoing compliance program. Our field staff in FDA district offices conducts inspections that include products labeled as gluten-free. If a label is found to be in violation of our requirements, we would contact the company and give them an opportunity to make the appropriate corrections, at the same time working together to recall any mislabeled products on the market.” So far, she noted, compliance with the rule has been strong with FDA finding only one product labeled as gluten-free that tested positive for the contaminate out of the more than 250 products that the agency sampled. “That product was recalled and subsequent sampling did not find any products that violated the regulation,” she said, adding, “We are very encouraged by these findings.” While touting this early success, D’Lima said FDA is still pursuing reports that some products labeled as gluten-free still exceed the allowed level of the ingredient. “We encourage consumers who have had a bad reaction to a food product to contact the Consumer Complaint Coordinator in their region. The coordinator asks for specific information, such as when the food was eaten, a copy of the product label, where it was purchased, and what the lot number was if available,” she said. “This information assists the FDA district offices in collecting samples at the food facility, and we take it from there.” D’Lima emphasized: “Our primary goal is making sure that consumers get safe products and that whatever information is put on the label is correct.” Creating an even playing field Doing this not only improves the welfare of consumers who are allergic to gluten, but it has helped level the playing field for companies producing gluten-free food products, D’Lima said. “Manufacturers are producing more gluten-free food products than ever before, now that they have clear guidelines,” she said. Alessio Fasano, chief of pediatric gastroenterology and nutrition and director of the Center for Celiac Research and treatment at Massachusetts General Hospital in Boston, agreed that the final rule was a “game changer” for consumer and industry alike. Before the rule, he explained in the FDA post, “some of the labels would spell out that gluten was in there; some would say “contains natural ingredients” and among them could be gluten; others would not address gluten at all. … And this was the most stressful and worrisome issue that people with celiac disease were facing at that time. The lack of certainty about what they were buying created a lot of fear. I remember vividly in the early days we had a mother whose child was diagnosed with the disease. She went to the supermarket and called our dietitian to say, ‘You know, I spent three hours in the supermarket and I only got two things. And I was crying.’” But now, he reports that his patients tell him shopping for gluten-free product is a “breeze,” and ‘"f you go to the grocery store, you can see for yourself that there are aisles of gluten-free products.”

Strong compliance with gluten-free labeling could free FDA to focus more on cross contamination risk

Encouraged by positive early compliance rates with the ‘game-changing’ gluten-free labeling standard that went into effect in mid-2014, FDA could now focus its attention on reducing the risk of cross contact with gluten-containing foods and ingredients, according to the agency.

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