On Jan. 23, the FDA published its proposal to define the term "gluten-free" for voluntary labeling of specific foods. The proposal will stand a 90-day comment period after which the voluntary regulation should be implemented.
The proposal for a gluten-free label comes as part of the Food Allergen Labeling and Consumer Protection Act of 2004, which requires the Department of Health and Human Services to propose and implement rules for food labeling.
The proposal also intends to reduce the incidence of mislabeled and misbranded products by regulating the term "gluten-free." According to the FDA, to carry the label, a product must not contain any species of wheat (including durum, kamut, spelt), barley or rye, any crossbred hybrids of such grains or derivations those grains, such as flour, that have not had the gluten removed. All products bearing the label must contain fewer than 20 ppm of gluten.
This also applies to oats, which are themselves gluten-free, but are often rotated with wheat crops in farming resulting in potential cross-contamination.
The establishment of a defined, voluntary label would help manufacturers and retailers as well as customers, particularly those suffering from celiac disease, according to the FDA.
Celiac disease is an autoimmune disorder that occurs in the small intestine and is characterized by a reaction to gliadin, a gluten protein found in wheat, rye, barley and other grains. Possible symptoms include diarrhea, fatigue, anemia, poor absorption of nutrients, and even fertility complications.
While celiac disease has no cure, sufferers can get relief and live normally by abstaining from gluten-containing foods.
"Part of the process of getting diagnosed with celiac disease is learning what you can and cannot eat," said Beth Hillson, founder, Gluten-Free Pantry, vice president of product development and consumer information for Glutino USA and president of the American Celiac Disease Alliance. "These guidelines will take a lot of work out of that learning curve. With the new label, consumers can be 99 percent confident that what they are buying is in fact gluten-free."
Recent surveys suggest that while 1 percent of Americans — about 3 million people — suffer from celiac disease, only a fraction of those have been effectively diagnosed. Worldwide, the incidence of celiac disease is expected to expand tenfold over the next few years.
Since increases in diagnoses, the market for gluten-free products, which serve as alternatives to grain-based foods such as pastas, pancakes, breads and cereals, has grown from $210 million in 2001 to almost $700 million in 2006, and is expected maintain a 25 percent growth rate, possibly reaching $1.7 billion by 2010.
"Gluten-free foods are not necessarily healthier for the people without gluten intolerance because wheat tends to have more fiber and nutrients," says Hillson. "But for those with gluten- or wheat-intolerance, as well as offering legitimate gluten-free products, this label will be incredibly beneficial."