FDA Seeks to Clarify “Gluten-Free” Term on Product Packaging

FDA Seeks to Clarify "Gluten-Free" Term on Product Packaging
Following a protracted, 6-year long postponement, the U.S. Food and Drug Administration (FDA) has finally put in place regulation, outlining the requirement for a more transparent gluten-free labeling system. Currently, there is no stringent term, explaining precisely what is and isn’t defined as “gluten-free”, as the decision was left at the discretion of major manufacturers. Technically, even foods that are described as being gluten-free contain trace amounts of wheat, rye and barley (all of which comprise gluten); though, these minutia quantities of gluten are considered so insignificant as to not cause any harm to most celiac sufferers.

However, the reason the FDA has waded in on the issue, revolves around a lack of ubiquitous standardization. Where one manufacturer claims a certain parts per million (ppm) of gluten breaches the “gluten-free” threshold, a different manufacturer might have a different threshold limit. Obviously, this presents a number of issues. Firstly, celiac sufferers present with different degrees of disease severity; therefore, a given ppm value of gluten may affect some celiac sufferers, but not others. Further, when making everyday transactions, celiacs have the laborious task of investigating which products are suitable for consumption, based upon their condition. As things stand, arguably, the packaging might be construed as somewhat misleading.

Celiac disease is an autoimmune disorder, affecting over 3 million American people. The immune system comprises a host of white blood cells, including something called a lymphocyte. It’s believed that B and T lymphocytes contribute towards the inadvertent destruction of structures of the small intestine, called villi. These villi increase the surface area in the gut, ameliorating uptake of nutrients into the bloodstream. The gluten triggers a cascade of immunological interactions, which provokes the condition, resulting in abdominal pains, diarrhea, weakness and bloating. Undiagnosed and unmanaged celiac can manifest other medical complications, including nutritional deficiencies, osteoporosis, intestinal cancers and infertility, to name a few.

The new ruling, enforced by the FDA, specifies that any product falling under the banner of “gluten-free” must contain less than 20ppm of gluten. A vast number of companies already fulfill the new standard, without any alterations necessary. However, Andrea Lovario, an employee of the American Celiac Disease Alliance, cautions that certain food constituents are concealed within the products. Notification of wheat presence within a food source is legally mandated, however, cross-contamination with other foods often leads to small quantities of barley and rye, polluting celiac products. Lovario categorically states, under the latest ruling, that this will be prevented.

When queried on the implications of the changes, FDA Commissioner Margaret A. Hamburg proclaims “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.” The FDA has recommended packaging manufacturers comply with the demands as quickly as possible, and a deadline of one year (ending September 2014) has been imposed upon those who don’t already meet the new standards. Those companies failing to acquiesce to the limits set could face seizure of goods, or product recall.

Many argue these steps have been a long time coming, with proposals being delayed since George Bush’s administration. Congress requested the FDA set standards, back in 2004, as part of a scheme to generate a comprehensive list of allergens for display on food packaging. However, looking at the situation cynically, these changes may have been inspired by the sheer revenue generated by distribution of gluten-free products, earning a staggering $4 billion last year. But, whatever the reason, this is certainly a step in the right direction and will, no doubt, be embraced by celiac sufferers.

Written By: James Fenner

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