In the wake of today’s news that the FDA gluten-free food labeling regulations have (finally) been finalized, there are a lot of questions about what, exactly, this means.
A quick review of how we got here and what this means for consumers reading labels, going forward:
In 2007, the FDA attempted to tackle the task of defining “gluten-free” for the purposes of labeling consumer products. Although they proposed a rule and opened a comment period, no final rule was ever issued.
In May of 2011, the founders and collaborators of 1in133.org constructed the “World’s Tallest Gluten-Free Cake” and submitted a petition to the FDA with over 10,000 consumer signatures demanding that the FDA finish the task of defining “gluten-free” food labeling regulations.
Deputy FDA Commissioner Michael R. Taylor joined Congresswomen Lowey and McCollum at the 1in133 “Gluten-Free Food Labeling Summit” held in Washington, DC, where he assured the group that the FDA would take up the task with renewed vigor, and promised to have draft regulations out within 3 months. (see photos of cake and the event here)
True to his word, on August 2, 2011, the FDA issued draft regulations and reopened a comment period on the January 23, 2007 rules.
Once the comment period closed, FDA considered the new science and safety assessments and issued a final rule, which it submitted to the Office of Management and Budget (OMB) and the White House for approval. The regulations had been awaiting approval until today, when it was announced (two years to the date that the FDA re-opened the comment period in 2011, and the 9th anniversary of the Food Allergen Labeling and Consumer Protection Act – FALCPA) that the final rules had been approved, and would go into effect in exactly 1 year, on August 2, 2014.
The new FDA regulations do many things, but the core principles of the regulations allow manufacturers to voluntarily label a food “gluten-free” if the food does not contain any of the following:
an ingredient that is any type of wheat, rye, barley, or crossbreeds of these grains (“prohibited grains”)
an ingredient derived from these grains and that has not been processed to remove gluten
an ingredient derived from these grains (like wheat starch) that has been processed to remove gluten, if it results in the food containing 20 or more parts per million (ppm) gluten
20 ppm or more gluten or 20 micrograms or more gluten per gram of food
The goal of these regulations is to establish a definition for the term “gluten-free” and uniform conditions for its use in the labeling of foods will ensure that persons with celiac disease and gluten sensitivity are not misled and are provided with truthful and accurate information. The FDA says it is “setting a gluten limit of less than 20 ppm (parts per million) in foods that carry this label. This is the lowest level that can be consistently detected in foods using valid scientific analytical tools. Also, most people with celiac disease can tolerate foods with very small amounts of gluten. This level is consistent with those set by other countries and international bodies that set food safety standards.”
Foods such as bottled spring water, fruits and vegetables, and eggs can also be labeled “gluten-free” if they inherently don’t have any gluten.
This final rule applies to all FDA-regulated foods, including dietary supplements, but does not apply to foods and beverages whose labeling is regulated by the U.S. Department of Agriculture (USDA) and/or the Alcohol and Tobacco Tax and Trade Bureau (TTB). FDA: “Generally, USDA regulates the labeling of meats, poultry, and certain egg products (FDA regulates the labeling of shell eggs). TTB regulates the labeling of most alcoholic beverages, including all distilled spirits, wines that contain 7 percent or more alcohol by volume, and malted beverages that are made with both malted barley and hops.” Because the ELISA testing methods currently accepted for testing gluten in foods ”do not adequately detect gluten in fermented and hydrolyzed foods” (like ‘de-glutenized beer’), FDA reports that it intends to issue a proposed rule on regulating labeling for these products.
The regulation was published on Aug. 1, 2013 in the Federal Register, and gives manufacturers exactly one year to bring their labels into compliance. Taylor “encourage[s] the food industry to come into compliance with the rule as soon as possible.” (read more here)
Under the new rule, a food label that bears the claim “gluten-free,” or “free of gluten,” “without gluten,” and “no gluten,” but fails to meet the requirements of the rule would be deemed misbranded and subject to regulatory action by FDA. (read FDA Q&As here)
“This is a huge victory for people with celiac disease,” says Andrea Levario, executive director of the American Celiac Disease Alliance (ACDA). “In fact, that’s the understatement of the year.”
➤To hear more about the regulations and what they will mean for gluten-free consumers, listen to the free podcast of my radio interview with Andrea Levario of the ACDA.
Congratulations to all of those who supported the 1in133.org endeavor, donated to the cause, spread the news and signed our petition. It truly was a community effort we can all be proud of.
So pat yourself on the back the next time you are shopping and see a gluten-free label — we can now look forward to knowing what that means!