Risks to patients grow with FDA labeling delays

In its report on FALCPA, the House Energy and Commerce Committee referenced the “devastating nature of celiac disease,” referring to serious secondary symptoms: osteoporosis, miscarriage, anemia, depression, and in children, short stature. Or it may have been a reference to the fact that celiac disease is linked to other lifelong, chronic conditions such as type 1 diabetes, fibromyalgia, Down syndrome, and certain cancers.

FALCPA requires manufacturers to clearly identify if a product contains ingredients derived from any of the top eight allergens: milk, eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat or soybeans. Of particular importance to the celiac community was the provision requiring that the FDA establish standards for “gluten-free” labeling by August 2008 – a necessary step because the U.S. lacks a standard and because there is no single, worldwide definition for the term “gluten-free.” Additionally, since the law did not cover barley and rye, the other two forbidden grains for celiacs, the rules would fill this labeling gap.

Manufacturers of gluten-free products in Europe follow rules promulgated by the Codex Alimentarius Commission, which has a standard of 20 parts per million (ppm), meaning a product must contain no more than 20 ppm to be labeled gluten-free, similarly Canada requires less than 20ppm.

Australia and New Zealand have the strictest requirements where products must test to 3ppm or less, currently the lowest detectable level through the most sensitive commercial testing. The FDA proposed a 20ppm level in January 2007.  

In 2003, U.S. sales of gluten-free products totaled $100 million. Between 2004 and 2009, gluten-free product sales increased 74 percent and are expected to exceed $2.5 billion by 2012.

It is the skyrocketing sales and the growth in the numbers of products and companies utilizing gluten-free labels that alarm the celiac community. The absence of labeling rules generates fear and anxiety among individuals whose lives are dependent on the safety of the products selected in the marketplace.

This January, the FDA’s first annual Reportable Food Registry Report was released. Of the 2,240 reports, over one-third were the result of undeclared allergens. Additional information from the Food Allergy and Anaphylaxis Network (FAAN) Special Allergy Alerts indicates that 17 products with undeclared wheat were recalled in 2010, with 10 to date this year. These are recalls issued by the FDA, the USDA, or the manufacturer. 

We have all heard the call to lead healthier lives, and doing so will help to reduce health care costs.  For individuals with celiac disease, and gluten-sensitivity, this cannot be accomplished without the information mandated by FALCPA.

To call attention to this issue, leaders and advocates from the celiac community gathered on May 4th for a Gluten-Free Labeling Summit. The event, held at the Embassy Suites Convention Center, featured the world’s tallest gluten-free cake, a symbol of the big deal labeling and safe foods are to this community. Rep. Nita Lowey, who earlier in the day introduced H.Res. 246, recognizing May as National Celiac Awareness Month, spoke about the need for improved labeling.It is our hope that Congress will urge the FDA, as the Energy and Commerce Committee did seven years ago, to move forward in an expeditious manner and complete the gluten-free labeling rules.

Beth Hillson is the president of the American Celiac Disease Alliance.