Home Food The FDA’s slow process is failing to protect celiac patients

The FDA’s slow process is failing to protect celiac patients

by trpliquidation
0 comment
The FDA's slow process is failing to protect celiac patients

There comes a time in every child’s life when they begin to discover that even though parents seem to have all the answers, adults generally don’t have it all figured out. Some children learn that lesson much earlier than others.

Unfortunately, that moment came far too early in life for 11-year-old Jax Bari. Jax suffers from celiac disease, a life-threatening and life-crippling food allergy and autoimmune disease that affects 3.3 million Americans. Celiac disease is caused by eating gluten, a protein found in wheat, barley, rye and most oats.

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

In the long term, gluten intake for celiac patients can increase the risk of anemia, cancer, heart disease, immunological scarring, intestinal damage, malnutrition and developing other autoimmune diseases. Unlike other food allergies, there are no ‘rescue medications’ available for accidental ingestion. Until there is a treatment other than a strict gluten-free diet, Jax will have to deal with this for the rest of his life because this is an allergy that cannot be outgrown.

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

However, what seems like such a simple and straightforward solution, especially for children, is not at all. Because consumer reports supports Following his citizen petition, I attended a meeting with Jax and FDA Deputy Commissioner Jim Jones and heard Jax passionately defend his common sense case against the FDA’s senior leadership by sharing his experiences and the science that supported his petition of the World Health Organization and the UN Food and Agriculture Organization Trying to explain how the regulatory process works to an 11-year-old is almost a futile exercise given the glacial pace and lack of logic that often pervades it.

During the meeting, Jax wore his favorite football player’s jersey – Travis Kelce, No. 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 requiring gluten listed on all food labels. The need to grant this request 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 of whom “there are people on all sides” demanding gluten labeling. It’s also difficult to explain to Jax how the institutional culture at the FDA can work against you, and how things like comment periods, proposed rules, final rules, and a recalcitrant bureaucracy can prolong this process for years. It’s also hard to explain that there would be opposition to this proposal, which leaves Jax wondering: Who is really against helping people — including about 750,000 like Jax — from getting sick?

Unfortunately, that’s what Jax discovers during his journey. He learns that the speed at which our nation’s food policy rushes to defend industrial profits at the expense of public health can sometimes be astonishing. Receiving this type of food safety education at such a young age can facilitate the maturation process much earlier 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 the leadership of Deputy Commissioner Jones to lead by example and move away from the Reagan-Udall Foundation’s finding that the FDA’s culture “ creates an environment in which decision-making is unacceptably slow” and from an The external perspective appears “slow and unresponsive to public health concerns.”

The FDA must restore Jax’s faith in adults and in the food regulatory system. It’s an easy fix, and the FDA should act quickly to help celiac patients who don’t have to wait several years for an uncertain regulatory process. This presents an opportunity for the agency to stand up and declare: Yes, Jax, there is an FDA, and the ‘F’ is silent no longer.

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 previously served in the office of Representative Rosa DeLauro of Connecticut.

You may also like

logo

Stay informed with our comprehensive general news site, covering breaking news, politics, entertainment, technology, and more. Get timely updates, in-depth analysis, and insightful articles to keep you engaged and knowledgeable about the world’s latest events.

Subscribe

Subscribe my Newsletter for new blog posts, tips & new photos. Let's stay updated!

© 2024 – All Right Reserved.