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FDA Establishes Definition of ‘Gluten-Free’ for Food Labels

The U.S. Food and Drug Administration on Friday issued a set of standards for food manufacturers wishing to label a product “gluten-free.”

The agency set a limit of 20 parts per million for the amount of gluten that may be present in foods marketed as gluten-free. The rule also extends to foods labeled “free of gluten,” “without gluten” or “no gluten.”

FDA’s final rule on gluten-free labeling comes six years after the agency published its proposed definition of gluten-free in 2007 and 9 years after Congress requested a universal definition of gluten-free from the agency in the Food Allergen Labeling and Consumer Protection Act (FALCPA).

The push for a standard definition for the term “gluten-free” has been spurred by an increase in the number of people diagnosed with celiac disease over the past few years. Celiac disease prevents a person from being able to absorb nutrients after eating gluten. An estimated 1 percent of Americans are thought to have the condition, although 83 percent of cases currently go undiagnosed.

“Adherence to a gluten-free diet is the key to treating celiac disease, which can be very disruptive to everyday life,” said Margaret Hamburg, commissioner of FDA, in a comment on the new rule. “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.”

Sales of gluten-free foods have been on the rise recently, reaching $2.6 billion in 2010. That figure is estimated to hit $5 billion by 2015.

FDA said it chose 20 ppm rather than 0 ppm as the limit because current scientific methods can’t detect levels of gluten below 20 ppm.

“In addition, some celiac disease researchers and some epidemiological evidence suggest that most individuals with celiac disease can tolerate variable trace amounts and concentrations of gluten in foods (including levels that are less than 20 ppm gluten) without causing adverse health effects,” the agency stated in its Q & A on the new rule.

The amount of 20 ppm of gluten in food can be visualized by picturing 2 grains of salt in a piece of bread.

Celiac awareness advocates praised the release of the rule.

“For years, gluten-free labels have gone unregulated, putting our gluten-free community in danger,” Alice Bast, president of the National Foundation for Celiac Awareness, said in a statement Friday. “We applaud the FDA for finally publishing a standard definition of gluten-free.”

The new rule applies to all FDA-regulated foods and drinks, including dietary supplements.

© Food Safety News
  • ethanspapa

    It’s either got gluten or it doesn’t. It’s black and white, not gray, not maybe or a little bit. For all you greedy miscreants trying to circumvent the rules, > You sit on the toilet for hours and cramp waiting for your intestines to fall in the toilet <. Or watch your little one die from dehydration or heart failure due to electrolyte imbalance. Money wins again.

    • Gary

      You are right; it either has gluten or it does not. However, that is not to say that 1 part per million will affect someone in the same way 20 parts per million will affect someone. The 20 PPM limit was established based on current testing methods detection limit. How can you prove there is 0 PPM of gluten if a test cannot detect it?

      I feel for anyone who has to manage a diet around celiac disease or a gluten sensitivity (yes they are different). But, there has to be practicality applied and this is the first step. As testing becomes more sophisticated the PPM limit will probably be adjusted, as well as, when the continued studies show the tolerance limits people have with celiac disease or a gluten sensitivity. This will unfold to the big 8 allergens and hopefully have some sort of limits for all of them. When we get to this point it will be a positive note for the consumer, food manufacturers, regulatory, and legal firms.

  • Hiimtddy

    Since I was just diagnosed today, I think it is great they are making it know that manufacturers can’t lie about what is in the food. It’s all very confusing trying to eliminate gluten when you don’t really know what it is. I just know I’m sick and don’t want to be sick anymore.