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Gluten Decree: The FDA Standard

Gluten free has been a government-regulated standard in Europe for more than 25 years, but in the United States the closest equivalent has been voluntary certification from advocacy organizations like the Gluten Intolerance Group and the Celiac Sprue Association. Until now, that is. The Food and Drug Administration is poised to release its long-awaited standard for the $1.3 billion gluten-free industry.

“Gluten free” has been a government-regulated standard in Europe for more than 25 years, but in the United States the closest equivalent has been voluntary certification from advocacy organizations like the Gluten Intolerance Group and the Celiac Sprue Association.

Until now, that is. The Food and Drug Administration is poised to release its long-awaited standard for the $1.3 billion gluten-free industry. This comes as a safety net — and a relief — for the estimated 3 million people with celiac disease, and millions more who are allergic to wheat. It's also a benchmark for manufacturers to follow in formulating and reformulating their products.

“There's been a lot of confusion up until now as to what gluten-free actually means,” said Vanessa Maltin, spokeswoman for the National Foundation for Celiac Awareness. “There's been a lot of debate on how many parts per million it should be.”

The FDA threshold is extremely conservative. Products can be labeled as gluten-free provided they contain no more than 20 parts per million of gluten. This is widely believed to be the lowest testable level, and it's the same limit that Europe's Codex Alimentarius recently set when it revised its own standards for gluten-free products back in July. This consistency should, among other things, help people with gluten intolerance who travel between continents, said Maltin, who has celiac disease.

According to the NFCA, the gluten-free products industry is growing at a rate of 20% annually. By 2010, the group expects the industry to be worth $1.7 billion.