FDA Finalizes Gluten-Free Standard

in Celiac
Published: August 2, 2013

Press Release from the American Celiac Disease Alliance:

ALEXANDRIA, VA – August 2, 2013 – The American Celiac Disease Alliance (ACDA), the nation’s leading celiac disease advocacy organization, today applauded the Food and Drug Administration (FDA) for establishing a federal standard for gluten-free labeling. The long-awaited regulation will help to ensure that individuals with celiac disease have the basic information necessary to manage their health and is the result of a decade-long effort led by the ACDA, which represents patients and those serving the celiac community.

The Food Allergen Labeling and Consumer Protection Act of 2004 required the Secretary of Health and Human Services to set labeling standards to aid the estimated 3 million Americans with celiac disease. Today, the only treatment for the genetic, autoimmune condition is to follow a strict gluten-free diet.

The new rule will require products bearing a gluten-free label to contain less than 20 parts per million (ppm) or 20mg/kg of gluten, a level research has found to be safe. Gluten is the common name for the protein found in all forms of wheat, as well as rye, barley and triticale, and is harmful to persons with celiac disease and non-celiac gluten sensitivity. A similar international standard was adopted as part of the Codex Alimentarius in 2008, and implemented in the European Union last year.

“A decade ago, our research determined that the prevalence of celiac disease in the United States was 1 in 133. Even then it was obvious that patients could not safely manage their diet without better labeling requirements,” noted Dr. Alessio Fasano, Director of the Center for Celiac Research at MassGeneral Hospital. “The FDA has devoted years of work to make sure the standard issued today was safe for celiac patients. Our research supports that standard,” he added

“We have worked closely with the FDA, providing input and offering the expertise of our members to make sure the rule met the needs of patients and minimized the impact on the ability of food manufacturers to deliver products to market,” said ACDA President Beth Hillson. “Now, we must turn our focus to partnering with FDA to educate patients, health professionals and industry about the standard and how it will benefit the entire community.”

Effective August 2, 2014, companies opting to label their products as gluten-free will be required to comply with the standard of less than 20ppm gluten. Once in place, celiac and gluten-sensitive consumers will be able to choose products with confidence.

“Creating a uniform definition for what gluten free means across all products will enable them to safely and easily navigate through the ever-expanding gluten free product aisles,” said TJ McIntyre, Senior Vice President and General Manager for Boulder Brands. The standard will also dramatically reduce the amount of time celiac and gluten-sensitive consumers spend contacting companies to obtain the information necessary to determine if a product is safe.

Scott Mandell, CEO of Enjoy Life Foods emphasized, “Our company is excited to know there is a clear standard and guidelines for making a gluten-free claim.” The company has been a pioneer in tracing the sources of ingredients used in its products, which are free from the top eight allergens as well. “Without a doubt, this standard will ease anxiety and confusion for those who must adhere to the gluten-free diet for medical reasons.”

The year FALCPA was signed into law, sales of gluten-free products were $560 million, and rose to $4.2 billion last year. By 2017, the sales of gluten-free foods and beverages are expected to exceed $6.6 billion. The skyrocketing growth in the market increased the need for FDA’s action to set a national gluten-free standard.