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FDA’s sluggish process is failing to protect celiacs

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There comes a moment in every child’s life when they begin to discover that, although their parents may seem to have all the answers, adults in general do not really have everything figured out. Some kids learn that lesson much sooner than others.

For 11-year old Jax Bari, that moment unfortunately arrived far too soon in his life. Jax suffers from Celiac Disease, a life-threatening and life-debilitating food allergy and auto-immune disease that affects 3.3 million Americans. Celiac is triggered by eating gluten, a protein found in wheat, barley, rye and most oats.

When people with Celiac ingest gluten – even just a crumb –  it can make them very sick and interfere with basic life activities:  eating, sleeping, thinking, learning and working. Celiac makes it difficult for them to safely eat out at most restaurants and participate in social activities involving food because of the high risk of accidental gluten ingestion with cross-contamination. Celiac also can prevent them from making certain career choices and serving in the military. 

In the long-term, gluten ingestion for Celiacs can increase the risk of anemia, cancer, heart disease, immunological scarring, intestinal damage, malnutrition and developing other auto-immune diseases. Unlike other food allergies, there is no ‘rescue’ medication available in the event of accidental ingestion. Until there is any type of treatment other than a strict gluten-free diet, Jax will be dealing with this for the rest of his life because this is an allergy that can’t be outgrown. 

There’s something that can be done now that would be extremely helpful to those suffering from Celiac. Since 2006, only wheat has been required to be labeled in the U.S., but not barley, eye and oats. Through a Citizen Petition submitted to the Food and Drug Administration (FDA) in September 2023 by Celiac Journey, which was founded by the Bari family, Jax is pushing the agency to issue a rulemaking now to require the labeling of gluten as a major food allergen on all packaged foods in the U.S. This can be accomplished using the FDA’s existing statutory authority granted under the Food Allergen Labeling and Consumer Protection Act of 2004. 

However, what may seem like such a simple and straightforward solution, especially to children, isn’t at all. Because Consumer Reports supports his Citizen Petition, I attended a meeting with Jax and FDA Deputy Commissioner Jim Jones, and heard Jax passionately make his common-sense case to senior FDA leadership by sharing his lived experience and the science to support his petition from the World Health Organization and the Food and Agriculture Organization of the U.N. Trying to explain how the regulatory rulemaking process works to an 11-year old is almost a futile exercise given its glacial pace and the lack of logic that tends to permeate it.

At the meeting, Jax wore his favorite football player’s jersey – Travis Kelce, #87 – because that’s what 11 year olds like to wear, but also to symbolize the 87 other countries around the world that consider gluten a priority allergen and require that gluten be declared on all food labels. The need for this petition to be granted is significant.

At the HHS Food is Medicine Summit in January, FDA Commissioner Califf responded to Jax’s public plea for help in front of 400 people that “there are people on all sides of” requiring the labeling of Gluten. It’s also difficult to explain to Jax how institutional culture at the FDA can work against you, and how things like comment periods, proposed rules, final rules, and a recalcitrant bureaucracy can allow this process to get extended for many years. It’s also difficult to explain that there would be opposition to this proposal, which makes Jax wonder:  Who is really against helping people – including about 750,000 like Jax — from becoming sick? 

Unfortunately, that’s what Jax is discovering in his journey. He is learning that the velocity with which our nation’s food policies rush to defend industry profits at the expense of public health can be astonishing sometimes. Receiving this kind of food safety education at such a young age can facilitate the maturation process far sooner than it should. But it also somehow energizes Jax to use his voice to speak truth to power.

Jax’s Citizen Petition represents a perfect opportunity for the FDA’s Human Foods Program under Deputy Commissioner Jones to lead by example and break away from the Reagan-Udall Foundation’s finding that the FDA’s “culture creates an environment where decision-making is unacceptably slow” and from an external perspective appears “sluggish and non-responsive to public health concerns.”

The FDA needs to restore Jax’s faith in adults and in the food regulatory system. It’s an easy solution, and the FDA should act quickly to help Celiac sufferers who shouldn’t have to wait several years for an uncertain rulemaking process to play out. This presents an opportunity for the agency to stand up and declare:  Yes, Jax, there is an FDA, and the ‘F’ is no longer silent.

About the author: Brian Ronholm is Director of Food Policy for Consumer Reports. He previously served as Deputy Under Secretary for Food Safety at the U.S. Department of Agriculture (USDA) and, prior to that, served in the office of Rep. Rosa DeLauro of Connecticut. 


Source: https://www.foodsafetynews.com/2024/09/fdas-sluggish-process-is-failing-to-protect-celiacs/


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