FDA defines “Gluten-Free” for Food Labeling

Washington, D.C. – Celiac disease is a serious health issue that can lead to critical complications if not treated.

While there is no cure for celiac disease (CD), there is one way to manage it – following a gluten-free diet. The only choice for the up to three million Americans living with CD is to adhere strictly to a gluten-free diet, avoiding proteins that occur naturally in wheat, rye, barley and cross-bred hybrids of these grains.

To do otherwise is to risk gradually damaging the intestines, preventing the absorption of vitamins and minerals and leading to a host of other health problems, including nutritional deficiencies, osteoporosis, miscarriages, and cancer.

Without a standard definition of “gluten-free,” people with gluten-related health problems can never be certain if a food is likely to be tolerated by them. So as a person living with CD for over a decade, I’m delighted to say that today, FDA is mandating a new rule on food labeling that will help people with CD – people just like me –be able to trust what the words “gluten-free” mean on their food purchases.

Not only will this help those with CD manage their disease more carefully, but it will also improve life for many others who are gluten intolerant or gluten sensitive.

Food manufacturers have come a long way in providing terrific options for those who need to eat a gluten-free diet. And by providing a clear definition of the term “gluten free” for all manufacturers to follow, this rule will help ensure that all of the “gluten-free” claims on food products are reliable, consistent, and truthful.

This is a very big deal. A celiac patient without access to proper treatment – a strict, gluten-free diet – could suffer severe health problems. I suffered from stomach issues my whole life and was constantly misdiagnosed with ulcers even as a young child. Since my correct diagnosis, I have worked hard to avoid gluten, but it is challenging. This new rule will help all of us with CD better manage our diets and our health.

According to the National Foundation for Celiac Awareness, one of every 133 Americans has CD, and 83 percent are undiagnosed or misdiagnosed with other conditions. But as consumers and health care professionals become more aware of the disease and how to cope with it, and more confident that they can trust that those products labeled gluten-free meet a standard definition, the better off we’ll all be.

CD can affect anyone; it doesn’t discriminate against race, age or gender. It can make eating, which I consider one of life’s great pleasures, a minefield, a thrice-daily event that is fraught with anxiety and peril.

It’s not the FDA’s job to tell people what they should and shouldn’t eat, but it is our responsibility to make sure that people can trust what the labels say on the foods they do choose to eat. I am proud to say that today we have taken a huge step towards helping all of us with CD or any kind of gluten-sensitivity confidently manage our health. And that is good for everyone.

Written by Virginia A. Cox, J.D.
Associate Commissioner of FDA’s Office of External Affairs.

Gluten-Free Labeling of Foods

An estimated 3 million people in the United States have celiac disease. In people with celiac disease, foods that contain gluten trigger production of antibodies that attack and damage the lining of the small intestine. Such damage limits the ability of celiac disease patients to absorb nutrients and puts them at risk of other very serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers.

On August 2nd, 2013, FDA issued a final rule defining “gluten-free” for food labeling, which will help consumers, especially those living with celiac disease, be confident that items labeled “gluten-free” meet a defined standard for gluten content.

• News Release: FDA defines “gluten-free” for food labeling
  The regulation will provide a uniform standard for manufacturers who choose to label their products as “gluten-free.” It will also help the estimated one in every 133 people – about 3 million people in the United States – who have celiac disease, a condition that can only be managed by eating a gluten-free diet.
• Federal Register Notice for the Gluten-Free Labeling Final Rule
• Questions & Answers: FDA’s Final Rule on Gluten-Free Labeling
• Consumer Update: What is Gluten-Free? FDA Has an Answer
  People with celiac disease can now have confidence in the meaning of a “gluten free” label on foods.
• Blog: Gluten-Free Labeling Consumers Can Count On