FDA Considers Official Definition for Gluten-Free Foods

Food manufacturers that are looking for new opportunities might want to consider gluten-free products. On January 23, 2006, FDA proposed allowing voluntary labeling for the products, which lack proteins in wheat that can harm people with celiac disease-a chronic inflammatory disorder of the small intestine that affects up to 1% of the general population.

According to Mintel (Chicago), gluten-free product launches jumped by 86% in 2006, with particularly strong growth in North America, Europe, and Latin America. A standardized definition of the term gluten-free, along with clearer labeling, could help ignite a boom akin to the one experienced by organic products in the last decade.

FDA‘s proposal was mandated by the Food Allergen Labeling and Protection Act of 2004, which requires the secretary of the Department of Health and Human Services (Washington, DC) to define and permit the use of gluten-free labeling. FDA already allows manufacturers to claim voluntarily that products are gluten free if the claims are truthful.

To be eligible for the labeling, foods would need to meet several requirements. First, they could not contain ingredients with prohibited grains such as wheat, rye, and barley or their hybrids. Second, they could not contain ingredients derived from prohibited grains that are not processed to remove gluten. Third, they could not contain ingredients that would result in the presence of 20 ppm or more of gluten per gram of food. Fourth, the food itself could not contain 20 ppm or more of gluten per gram of food.

The proposal would also allow claims for products that are naturally free of gluten, such as fruit, provided that the foods do not contain more than 20 ppm and that the wording of the claim indicates that all foods of the same type are gluten-free. FDA added that oats would be permitted under the proposal, as long as the food‘s gluten content did not exceed 20 ppm.

The agency said it set the 20 ppm limit because current analytic technology can detect gluten in wheat, rye, and barley at levels of 20 ppm in a variety of food matrices. FDA added that data suggest that people with celiac disease can tolerate up to 50 g of oats that are free of gluten from wheat, rye, barley, or hybrids like triticale.

According to FDA, manufacturers and consumers alike should benefit from the claim. “A standardized definition of the term gluten-free could assist food producers by providing them with a clearly codified definition of the term, thereby eliminating any uncertainty or misunderstandings as to how they may label their products,” FDA wrote, adding that the definition would also “serve to protect the public health by providing consumers with celiac disease, and others who must avoid gluten in their diet, the assurance that the foods bearing this labeling meet a clear standard established and enforced by FDA.”

The proposal will be of interest to the approximately 1% of Americans with celiac disease, say manufacturers.

“Based on the questions and overwhelmingly positive feedback that we receive every day from consumers with celiac disease, these new guidelines will be greatly appreciated,” says Jim Garsow, director of marketing at TH Foods Inc. (Loves Park, IL), which manufactures the popular Mr. Krispers line of gluten-free baked rice crisps.

“As the leading manufacturer of rice crackers in North America, we will be evaluating the new guidelines closely to make sure that all of our products carrying a gluten-free claim will comply with the new FDA regulations and exceed our customer and consumer expectations,” Garsow adds.

After USDA (Washington, DC) unveiled the National Organic Program in October 2002, demand for organic products skyrocketed. Manufacturers of gluten-free products clearly hope the new rules will do the same.

“Just like the organic guidelines that were released several years ago, the gluten-free labeling guidelines will greatly improve the consistency of gluten-free products, improve consumer confidence, and draw attention to this already rapidly growing segment of products,” Garsow says.