In response to consumers' shift toward foods they deem to be healthier — regardless of what science might say, gluten-free products and reformulations of popular products like Lucky Charms are prevalent in the market. In the 12 months leading up to April 2015, one in 10 global product launches was for a gluten-free product. That number increased to nearly one in five product launches in the U.S., with companies like Snyder’s-Lance expanding its gluten-free portfolio in the past year.
What are the FDA’s gluten-free rules?
The Food Allergen Labeling and Consumer Protection Act of 2004 required the issuance of federal regulations to "define" and "permit use of" gluten-free food labels. In 2013, the FDA issued a final rule to define what gluten-free for food labeling meant to clear up any confusion and enable companies to feel confident that the products they created appropriately bear the gluten-free label.
In short, the new federal definition of gluten-free means that to make a gluten-free label claim, a product must meet all requirements of the gluten-free definition, which includes containing less than 20 parts per million (ppm) of gluten. That is the lowest level that can be reliably detected in foods using analytical methods that the FDA feels are scientifically validated. Prior to this regulation, companies had no standard or definition to use when determining whether their products should have a gluten-free label.
This means that products cannot be directly made with ingredients that contain gluten nor can those products come into contact with gluten throughout processing and distribution. All products had to be compliant with this rule beginning in August 2014.
Before affixing a gluten-free label to their products, companies must ensure that product does not contain wheat, barley, or rye but also does not contain one of the less traditional and hidden sources of gluten.
Ensuring a reproducible gluten-free product
Jaclyn Bowen, general manager at Quality Assurance International and director of NSF International’s Consumer Values Verified Program, outlines three components of a reproducible gluten-free product: supply chain assurance, good manufacturing practices, and a robust training platform to ensure manufacturing employees understand their role in maximizing gluten-free integrity.
Last month, General Mills ran into issues with its Cheerios and Honey Nut Cheerios products, which have been labeled as gluten-free. The company had to recall 1.8 million boxes made at its Lodi, CA, factory in July because the facility’s gluten-free oat flour system was contaminated with wheat flour, which meant the products could contain gluten and pose a risk to those with celiac disease or gluten intolerance. Now the company is facing a class-action lawsuit.
In addition, confirmation testing should be in place to make sure all of the control procedures a company puts in place work correctly to create a reliably gluten-free product. Quality confirmation testing for gluten-free label claims is generally independent, third-party testing that simulates the same type of environment and procedures the FDA would use in an investigation to test whether a product can be considered gluten-free, Bowen said.
While third-party testing groups may use different protocols, the FDA uses two sandwich enzyme-linked immunosorbent assays (ELISA)-based methods: R-Biopharm’s Food & Feed Analysis and Morinaga Institute of Biological Science, Inc.’s Wheat Protein ELISA Kit (Gliadin). However, according to the FDA, "Sandwich ELISA methods do not adequately detect gluten in fermented and hydrolyzed foods. Because scientifically valid methods currently are lacking that can do so, we intend to issue a proposed rule on this issue."
Communicating with consumers
"In conversations with manufacturers, they are saying that on the 1-800-numbers on the backs of packages, the single biggest question they get is, 'Is your product gluten-free?'" said Bowen. "So sometimes it’s a matter of making sure that you are transparent in terms of making sure that you tell your consumers whether or not your product contains gluten or not."
According to Bowen, what is also important for companies to remember is "how much more educated consumers are becoming about the types of ingredients that are inside of products. They’re paying more attention. You’ve got a lot more label-readers around. So it’s a matter of manufacturers being prepared to answer those questions easily and confidently in the language that consumers can understand."