MassGeneral Hospital for Children News

Celiac patients and other consumers trying to sort the gluten-free from the gluten-filled, will have an easier time after August 5, when the FDA standards for gluten-free labeling go into effect.

FDA Implements Safety Standards for Gluten-Free Labeling

Center for Celiac Research Instrumental in Celiac Advocacy Efforts

05/Aug/2014

For celiac patients and other consumers trying to sort the gluten-free from the gluten-filled, the task will become a little easier after August 5, 2014. That’s the date that FDA standards for gluten-free labeling go into effect. After that date, regulations state (in part) that manufacturers who sell products labeled as gluten-free must ensure that the products contain less than 20 parts per million (ppm) of gluten, considered a safe level for most people with celiac disease.

Celiac disease is an autoimmune reaction to gluten, which is found in products made with wheat, rye and barley. The only available treatment is to follow a lifelong gluten-free diet. For the approximately 1 percent of the U.S. population with celiac disease, the final implementation of the gluten-free labeling rule has been a long time in the making.  

“We’ve been waiting for this day for more than ten years,” says Alessio Fasano, MD, director of the Center for Celiac Research and Treatment at MassGeneral Hospital for Children (MGHfC). “It’s only through the efforts of members of the celiac community, health care practitioners and visionary congressional leaders like the late Sen. Ted Kennedy and Sen. Nita Lowey that we can celebrate the final implementation of the Food Allergen Labeling and Consumer Protection Act (FALCPA).”

FALCPA, which became law in 2004, improved food labeling to make it easier for people with food allergies and sensitivities to identify potential allergens in manufactured food products. As part of FALCPA, in August 2013 the FDA issued a final regulation defining the term “gluten-free” as less than 20 ppm for use by food manufacturers of gluten-free products.

August 5 is the date for manufacturers to come into compliance with the rule. Products that do not meet the 20 ppm standard could be deemed as “misbranded” by the FDA and subject to regulatory action. With the rising popularity of the gluten-free diet among many consumers other than celiac patients, the market for gluten-free foods is booming; sales are projected to hit more than $6.6 billion by 2017.

“Now our patients can have more complete confidence that the foods they consume are safe,” says Pamela Cureton, RD, LDN, registered dietitian for the Center for Celiac Research. “Although there are still some unregulated areas in terms of gluten, such as meat and poultry, this is a huge step toward making it easier for people with celiac disease and other gluten-related disorders to shop safely for their food.” Because products that are gluten-free do not have to be labeled as such, consumers still need to read ingredient lists carefully to avoid products containing wheat, rye, barley, oats (unless labeled gluten-free), malt and brewer’s yeast. For people newly diagnosed with a gluten-related disorder, it’s important to work with a registered dietitian to ensure that their nutritional needs are met, says Cureton. 

Fasano and Cureton both urge individuals who think they might have a negative reaction to gluten to consult a health care professional. “There are several different kinds of harmful reactions to gluten ingestion, says Fasano. “Along with celiac disease, there is non-celiac gluten sensitivity, wheat allergy, gluten ataxia and dermatitis herpetiformis, an itchy skin rash caused by eating gluten. And people must be eating gluten in order to be properly tested for celiac disease; otherwise the antibodies that indicate the condition will no longer be present in their blood.”

Andrea Levario, executive director of the American Celiac Disease Alliance, which led efforts by the celiac community to include protections for celiac patients in FALCPA, applauds the final implementation, but notes there is more to be done. “Currently, some manufacturers are putting gluten-free labels on certain products -- such as bottled water or fruits and vegetables -- which are naturally gluten-free. We think this is confusing to consumers, and will advocate to have it changed,” says Levario.

For more information on the regulations, visit http://1.usa.gov/J26sSr and www.fda.gov

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