FDA proposes to define 'gluten-free'
rule to define the term 'gluten-free' for use on food labels.
The proposal, which has entered a 90-day public comment period, would establish a definition for voluntary use on labels, but these guidelines would also prevent product misbranding.
The establishment of a definition would benefit consumers and manufacturers alike, by avoiding inconsistencies and misleading claims. According to the FDA, such a definition is especially important for people suffering from celiac disease, as it would allow for the easy identification of packaged foods that are safe to eat.
This condition is characterized by an intolerance to gluten, a protein found in certain grains, including wheat, rye and barley. The disease has no cure, but avoiding the consumption of gluten can resolve its symptoms and reduce associated health risks.
Currently, there is no federal regulation that defines the term 'gluten-free' used in the labeling of foods.
"There is no universal understanding among US food manufacturers or consumers about the meaning of a food labeled as 'gluten-free.' FDA believes that establishing a definition for the term (…) and uniform conditions for its use in the labeling of foods will ensure that persons with celiac disease are not misled and are provided with truthful and accurate information," said the agency.
The proposed rule recommends the term be used to apply to foods that do not contain any of the 'prohibited' grains, including all species of wheat (such as durum wheat, spelt wheat or kamut), rye, barley, or their crossbred hybrids.
Derivatives of these ingredients, such as wheat flour or wheat starch, would also be prohibited, unless these have been processed to remove the gluten, resulting in the presence of less than 20 micrograms of gluten per gram of foods.
Products bearing a 'gluten-free' claim - or a similar claim - that fails to meet the conditions specified in the proposed definition would be deemed misbranded.
The proposed rule was prepared in response to the Food Allergen Labeling and Consumer Protection Act of 2004, which required the Department of Health and Human Services to propose, and later make final, a rule that defines and permits the use of the food labeling term.
According to the latest figures, around three million Americans, a little less than 1 percent of the population, currently suffer from gluten intolerance, although estimates suggest that 97 percent of celiac sufferers remain undiagnosed and go untreated. Estimates- suggest that the number of known sufferers of celiac disease will increase worldwide by a factor of 10 during the next few years.
An increased diagnosis of the disease in recent years has led to a consequent surge in demand for gluten-free goods. According to a report published last year by Packaged Facts, the market for gluten-free foods and beverages in the US currently stands at almost $700m, and is due to reach around $1.7bn by 2010.
Most gluten-free products are alternatives to traditional grain-based goods, including bakery products, pasta and cereals. These are made with alternative grains and flours, such as rice, corn, amaranth and quinoa.
In 2001, the market for gluten-free products was valued at $210m, and has grown at a compound annual growth rate of 27 percent since then, to reach $696.4m in 2006. The market is estimated to continue to grow at 25 percent per year until 2010.
But despite the strong performance of this sector, and the opportunities it entails, major food marketers have largely not entered the market as yet. According to Packaged Facts, this is because they are reluctant to invest in research and product development until fixed regulations for gluten-free are in place.
To view a copy of the FDA's proposed rule, click here.
