What is gluten-free? FDA's new rule

Date: Aug-04-2013A new regulation defining the term "gluten-free" has been published by the FDA (Food and Drug Administration). The FDA explained that the regulation is aimed at helping in the voluntary labeling of food products.

The FDA has been talking about redefining glucose-free labeling for several years. In 2011, the Agency reopened the proposed gluten-free labeling rule, which had been originally published in 2007.

Three million Americans are thought to have celiac disease. People with celiac disease have to avoid eating foods containing gluten, otherwise the lining of the small intestine becomes damaged, affecting the proper absorption of vital nutrients into the bloodstream.

The FDA says its new gluten-free regulation is aimed at helping patients with celiac disease maintain their gluten-free diet more effectively.

FDA Commissioner Margaret A. Hamburg, M.D., said:

"Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life. The FDA's new 'gluten-free' definition will help people with this condition make food choices with confidence and allow them to better manage their health."

Gluten-free means less than 20 parts per million

For a food to be labeled as gluten free, it must contain no more than 20 parts per million (ppm) of gluten, the FDA decided.

A gluten-free claim will mean less than 20ppm

Companies that sell products with any of the following claims on their labels will have to meet the 20ppm of gluten limit:

"Gluten-free"
"Free of gluten"
"Without gluten"
"No gluten"

It is most likely that several foods labeled as "gluten-free" already meet the new definition, the FDA emphasized.

Manufacturers and distributors of foods will be given a 12-month grace period after the new rule is published to bring their labels into full compliance with the new requirements.

Michael R. Taylor, the FDA's deputy commissioner for foods and veterinary medicine, said "We encourage the food industry to come into compliance with the new definition as soon as possible and help us make it as easy as possible for people with celiac disease to identify foods that meet the federal definition of 'gluten-free'."
Why is gluten-free 20ppm and not zero ppm?

The FDA says it relies on scientifically validated methods for enforcing its regulations.

Current technology cannot reliably measure gluten presence at lower than 20ppm.

According to some research and available evidence, the FDA added, patients with celiac disease can tolerate trace amounts of gluten in foods without experiencing adverse health effects. Trace amounts is defined as up to 20 parts per million.
What is celiac disease?

Celiac disease is an immune system disorder. The patient's immune system reacts when exposed to gluten, resulting in damage to the absorptive surface of the small intestine.

The immune system of people with celiac disease reacts to a gluten protein called "gliadin". Gliadin can be found in barley, rye and oats (sometimes).

When the lining of the small intestine is damaged, it cannot absorb fats, carbohydrates, proteins, minerals and vitamins properly.

Celiac disease can affect people who are genetically predisposed at any age. In most cases symptoms start to appear during middle infancy.

The main signs and symptoms of celiac disease include:

Diarrhea (chronic)
Weight loss
Fatigue
Anemia (iron deficiency)
Osteoporosis

Many people with celiac disease have no symptoms.

According to the FDA, people with celiac disease have a higher risk of the following complications:

Intestinal cancers
Short stature
Miscarriages
Infertility
Stunted growth
Several nutritional deficiencies

The most effective way to diagnose celiac disease is by taking a sample of tissue (biopsy) from the small bowel, usually via endoscopy. Scientists at the Celiac Disease Center, Columbia University Medical Center, say that celiac disease is under-diagnosed because not enough biopsies are performed during endoscopies. Blood tests may also help in diagnosing celiac disease.

Celiac disease is irreversible, i.e. there is no cure. The only effective treatment is to avoid consuming any foods or drinks that contain gluten.

Avoiding gluten is not as easy as it sounds. There are thousands of products on the market than have hidden gluten in them. The FDA believes its new rule regarding gluten-free labeling will help people avoid gluten more effectively.

The FDA says that it was "directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act (FALCPA), which directed FDA to set guidelines for the use of the term "gluten-free" to help people with celiac disease maintain a gluten-free diet."

The gluten-free final rule has been published in the Federal Register.

Written by Christian Nordqvist

Copyright: Medical News Today

Not to be reproduced without permission of Medical News Today
Courtesy: Medical News Today Note: Any medical information available in this news section is not intended as a substitute for informed medical advice and you should not take any action before consulting with a health care professional.