FDA Defines Gluten Free

FDA Defines Gluten Free
The FDA has issued a final ruling about which foods can be labeled gluten free. Manufacturers must comply by August 5, 2014.

The gluten limit has been set at 20 ppm (parts per million). A food may be labeled gluten free if it does not contain any of the following:

an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains
an ingredient derived from these grains and that has not been processed to remove gluten
an ingredient derived from these grains and that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten

For full details about the FDA ruling and definition, copy this link:
http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm363069.htm
Info from Healthy Villi newsletter, www.healthyvilli.org.

For the Celiac Sprue Association (www.csaceliacs.org) press release, see below:

7 August 2013
Press Release: At Once
From: Celiac Sprue Association – Omaha Nebraska
RE: FDA Rules on Gluten-Free Definition
Contact: Mary A. Schluckebier
Email – ExecutiveDirector@csaceliacs.org
Phone – 1-877-272-4272

Celiac Sprue Association responds to the Food and Drug Administration Gluten-Free Labeling Rule.

The Omaha based, national celiac membership organization, the Celiac Sprue Association (CSA), with a Seward satellite office, has long awaited the final rule defining the term “gluten-free” for voluntary use in labeling was issued by the Food and Drug Administration (FDA) on Friday August 2, 2013. The FDA was directed to issue the new regulation by the Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA). The final rule defines and sets conditions on the use of the term “gluten-free” in food labeling, including:
• Foods that inherently do not contain gluten (e.g. raw carrots or grapefruit juice) may use the “gluten-free claim”.
• Foods with any whole, gluten-containing grains (e.g. wheat, barley, rye, spelt) as ingredients may not use the claim.
• Foods with ingredients that are derived from gluten-containing grains that are refined but still contain gluten (e.g. wheat flour, barley malt) may not use the claim
• Foods with ingredients that are derived from gluten-containing grains that have been refined in such a way to remove the gluten may use the claim , so long as the food contains less that 20 parts per million (ppm) gluten/has less that 20 mg gluten per kg (e.g. wheat starch)
• Foods may not use the claim if they contain 20ppm or more gluten as a result of cross contact with gluten containing grains.

The final rule becomes effective 30 days after publication in the Federal Register. Manufacturers will have a year after the date of publication of the rule to bring package labels into compliance.

“It is a step in the right direction to have a definition and a level for gluten-free labeling,” stated Mary A. Schluckebier of Seward, CSA Executive Director of the Omaha based national organization. “The CSA membership has worked for almost a decade to see the long-awaited labeling regulations from the FDA,” stated Bill Locke, CSA national President from Midlothian, Virginia. “The CSA membership is happy to have a definition in place for gluten-free and will continue to work for individuals diagnosed with celiac disease.”

Longtime CSA volunteer and the Vice President of Governmental Affairs, Diane Eve Paley of New Jersey agreed with Schluckebier on CSA’s involvement for a gluten-free definition. “All of the members of CSA wanted a clear definition for the producers and industry. Ever since CSA organized in the Midwest almost four decades ago, there has been a plea for a definition of “gluten-free,” stated Paley. “We have lobbied Congress and worked with many US Senators and Congressmen, as well as leaders in the FDA to see this regulation enacted. We are indeed elated to see that government is listening and the people now have a consistent gluten-free definition!”

“The Celiac Sprue Association motto is ‘Celiacs Helping Celiacs’,” said Yvonne Steinbach, president of the Omaha based CSA Midlands Chapter #13. “This legislation really evolved because so many individuals with celiac disease and their families worked long and hard hours with their governmental leaders to developed this definition and create a threshold for gluten-free labeling.”

Omaha Registered Dietitian Shelly Asplin, MA, RD, LMNT and CSA Nutrition Program Coordinator commented, “A preview of the soon-to- be published, 95 page, FDA guidelines reveals some of the considerations that went into the 20 parts per million decision. The FDA acknowledges that the estimated risks to individuals with celiac disease associated with even a very low level of gluten exposure may be conservative. Nevertheless, concerns about the ability of food manufacturers to comply with stricter standards at reasonable cost may have contributed to the higher thresh-hold. Government officials expressed concern that setting a lower thresh-hold could cause some manufacturers to stop identifying foods as entirely, thus reducing choices for those most in need. Regardless, CSA members and dietitians are happy to have a definition in place.”

“In contrast to the FDA guidelines, the gluten-free certification requirements of the Celiac Sprue Association Recognition Seal Program are more stringent.” commented Sue Wickersham of Seward, CSA Recognition Seal coordinator. “Unlike the FDA definition, the CSA Recognition Seal Program does not allow the use of oats or ingredients that are derived from gluten-containing grains that have been refined in such a way to remove the gluten. The Program also uses the most stringent ELISA test equally cross reactive to wheat, barley and rye for testing purposes and products must test below level of quantitation at 5 ppm to qualify for CSA Recognition Seal status.”

After meeting with a producer of gluten-free food in Montana on Friday, August 2, 2013, CSA Executive Director Mary Schluckebier offered a concluding comment on the FDA guidelines. Schluckebier stated, “The contents of the guidelines were anticipated. The CSA membership applauds the FDA for their many hours of work in creating a definition and establishing guidelines. This is a good start at providing consistency in labeling for those individuals needing or wanting a gluten-free diet. However, CSA will continue to use our existing stricter Recognition Seal standards, and the value of our certification program has now been significantly enhanced. While the new FDA guidelines serve a valid purpose in enabling the government to have a threshold labeling standard for foods labeled, CSA Recognition Seal participating companies will be able to provide their customers the confidence that their products are truly risk-free choices.”

For more information, visit the CSA website at csaceliacs.org or contact the CSA office toll free at 1-877-CSA-4-CSA or visit the FDA website at www.fda.gov/

(L-R) Mary Schluckebier of Seward, Executive Director of Celiac Sprue Association discusses the impact of the new FDA gluten-free ruling with Richard Wergin, MD of the Milford Clinic – Memorial Health Care Systems – Nebraska. Dr. Wergin is also on the national board of “The American Academy of Family Physicians.”