A Conversation with Carol D'Lima and Alessio Fasano
People with celiac disease, an inflammatory disorder of the small intestine, could get very sick if they eat gluten, a mixture of proteins that occur naturally in grains and are found in many foods, including breads, cakes, cereals and pastas. To give these consumers confidence that foods voluntarily labeled “gluten-free” meet a standard established and enforced by the FDA, the agency issued a rule in 2013 that defines the characteristics a food has to have to bear such a claim.
This was an action long sought by advocates for people with celiac disease, who said that without a standardized definition, these consumers were forced to gamble with their health, never being sure that a food labeled “gluten-free” was really one their body would tolerate. Manufacturers had until August 5, 2014 to bring their labels into compliance with the requirement that a food labeled “gluten-free” must either be inherently gluten-free or does not contain an ingredient that is:
- a gluten-containing grain (e.g., spelt wheat);
- derived from a gluten-containing grain that has not been processed to remove gluten (e.g., wheat flour); or
- derived from a gluten-containing grain that has been processed to remove gluten (e.g., wheat starch), if the use of that ingredient results in the presence of 20 parts per million (ppm) or more gluten in the food.
- Also, any unavoidable presence of gluten in the food must be less than 20 ppm.
Three years later, what impact has defining the term “gluten-free” had on people living with celiac disease? Carol D’Lima, Ph.D., a food technologist in FDA’s Office of Nutrition and Food Labeling, and Alessio Fasano, M.D., chief of Pediatric Gastroenterology and Nutrition and director of the Center for Celiac Research and Treatment at Massachusetts General Hospital in Boston, talk about the real-world impact of this labeling standard.
Q: Can you provide some background on how this rule came about? It was a long time in the making. What were some of the challenges in those early days?
D’Lima: It really began with celiac disease patient groups calling for action. The Food Allergen Labeling and Consumer Protection Act of 2004 directed the Secretary of Health and Human Services to issue a rule to define the term “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.” These issues were ultimately resolved with the help of working groups, scientific research, and consultations with experts.
Fasano: 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. The community always showed up big time to give their opinion. Their ultimate issue was simply quality of life, the ability to go into a store and get foods they know are gluten-free. When the FDA rule became final, the news spread like wildfire. The industry knew this was coming, was involved in the discussions all along the way, and was prepared for it. This is a classic example of how it sometimes takes a village to make things happen.
Q: Before the gluten-free labeling rule, how difficult was it to determine whether a food is gluten-free?
Fasano: It was pretty much impossible, actually. 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. Compared to other markets, like Europe, we were really lagging behind. 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.”
Q: When you interact with stakeholders, what feedback have you received?
D’Lima: Consumers feel much more confident in the products they buy these days. And manufacturers are producing more gluten-free food products than ever before, now that they have clear guidelines that level the playing field for companies producing gluten-free food products.
Q: After the rule went into effect, did the FDA do anything to ensure that products with gluten-free labels were in fact gluten-free?
D’Lima: Yes. Earlier this year we released the results of a sampling assignment in which 702 samples from more than 250 products labeled “gluten-free” were analyzed. Only one of those products did not comply with our labeling requirements. That product was recalled and subsequent sampling did not find any products that violated the regulation. We were very encouraged by these findings.
Q: How much of a difference does it make to have a standard definition of what is called “gluten-free?”
Fasano: It’s been a game changer. At the beginning, many of us were worried about whether the promise of this new standard would truly be realized. But the food industry took this seriously and did an exceptional job with the new labels, aided by the fact that the FDA spelled out exactly what was required.
Q: Is the labeling helpful for people other than those with celiac disease?
D’Lima: The primary intention of the rule was to help people suffering from celiac disease, but the label can also benefit people who have a gluten sensitivity or intolerance. Finally, it’s also helpful to caregivers and food preparers. It helps a lot of people make informed decisions about what they’re eating.
Q: Have you heard from people that they have an easier time finding gluten-free products?
Fasano: Yes, my patients tell me it’s a breeze now. I wish I could talk now to that mother I mentioned earlier. If you go to the grocery store, you can see for yourself that there are aisles of gluten-free products.
Q: Would you recommend that people still carefully read the ingredients on food labels?
D’Lima: Definitely. While they can be confident about the “gluten-free” claim, I would always encourage consumers to read the information about ingredients and nutrition content. There is so much important information you can get from a food label.
Q: Is the agency’s focus now shifting more to the dangers of cross contact?
D’Lima: Cross contact generally refers to the unavoidable presence of gluten when a gluten-free food comes in contact with a gluten-containing food or ingredient. This may happen during processing due to poor manufacturing practices, such as sharing production equipment without properly cleaning between uses. Cross contact has always been important and is addressed in the gluten-free final rule. The rule limits gluten due to cross contact to less than 20 ppm in a food labeled as gluten-free.
Fasano: Cross contamination can also be an issue when a person with celiac disease eats outside the home. The people you’re visiting may not have a clear idea of the precautions that must be taken to keep ingredients with gluten out of a dish or to keep food contact surfaces free of foods that have gluten. For people with celiac disease, it’s a mental exercise all the time and when they’re going to someone’s home, they have to discuss what’s needed.
Q: Going forward, will the FDA continue to monitor products labeled gluten-free?
D’Lima: Yes 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.
Q: There have been news stories recently about complaints that some products still exceed the allowed level of gluten. Does the FDA follow up on stories like that? In general, are there next steps?
D’Lima: That’s something we strive to do, but in order to effectively follow up, we really need specific information about possible violations. 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. This information assists the FDA district offices in collecting samples at the food facility, and we take it from there.
Our primary goal is making sure that consumers get safe products and that whatever information is put on the label is correct.
Q: Dr. Fasano, as a pediatric gastroenterologist, how would you describe the impact of this rule on children?
Fasano: Kids have different kinds of challenges and lifestyle needs. And if you have kids, you know that they don’t like to look different from other kids. So now it’s possible to meet their dietary needs without calling a lot of attention to that. The abundance of accurately labeled, gluten-free products means that it’s not such a big deal for kids with celiac disease to go to camp or even just a sleepover at a friend’s house. Imagine what it was like for parents to have to send their kids to a sleepover with a cooler full of special foods. For people with celiac disease, knowledge about what foods contain gluten is as important as insulin is to diabetics. Even socializing and going on vacation were once challenging. Nowadays it’s much easier to enjoy your life.