Patients with the inherited autoimmune condition, celiac disease, must avoid gluten in any form to help heal damaged intestinal villi. The Food and Drug Administration’s (FDA) Gluten Free (GF) label is intended to help instill trust in consumers with celiac disease and gluten-related disorders. Studies show that the vast majority of labeled GF foods meet the FDA’s standard of <20 ppm gluten, but consumers remain leery of some labeled GF products, especially those displaying allergen advisory statements for wheat. Products containing malt, malt extract, and other gluten-containing ingredients continue to show up on store shelves, which may indicate that FDA enforcement of the GF labeling rule is lacking. Consumers may find a personal allergen detection tool to be an attractive option to assist in testing food for gluten content, but these also come with significant limitations.
Celiac disease is an autoimmune condition treatable only with a strict, lifelong GF diet.1 The FDA’s GF labeling rule, enacted in 2013, set the standard for what GF means on the food label.2 Despite research that shows that the vast majority of labeled GF products contain levels of gluten well below the FDA’s standard of <20 ppm gluten, many GF consumers continue to be concerned about the safety of labeled GF foods.3,4 These concerns may convince some that a personal allergen detection tool is necessary to assure that labeled GF food is safe. What are some of the issues surrounding GF labeling that should be addressed to help consumers feel more confident that the foods that they purchase are safe?
Allergen Advisory Statements
Because there is little regulation behind them, allergen advisory statements such as “made in a shared facility,” “made on shared equipment,” or “may contain” statements cause significant skepticism amongst GF consumers.5 Is this concern warranted? Are GF foods with allergen advisory statements for wheat inherently riskier than those without such warnings? The 2004 Food Allergy Labeling and Consumer Protection Act (FALCPA) states that any of the eight major food allergens present as an ingredient must be listed by either their “common or usual name of the major food allergen in the list of ingredients,” or “the word ‘Contains’, followed by the name of the food source from which the major food allergen is derived immediately after or adjacent to the list of ingredients…”.6 FALCPA only applies to the ingredients in the food; it does not apply to manufacturer practices.
In contrast, allergen advisory statements are voluntary on the part of the manufacturer. While the FDA does state that allergen advisory statements “should not be used as a substitute for adherence to Good Manufacturing Practices (cGMPs)” and must be “truthful and not misleading,” these statements are not otherwise defined under any federal regulation.
The FDA’s GF labeling rule states that any unavoidable gluten in a product making a GF claim must be < 20 ppm.2 This applies to gluten that may naturally be in the food as part of an allowed ingredient (i.e., wheat starch) or through unintentional cross-contact with wheat, barley, or rye. In other words, a product may carry a GF label claim in addition to an allergen advisory statement, provided the final product meets the standard of < 20 ppm gluten.2 The FDA does state that the allergen advisory statement must be “truthful and not misleading” and that the “FDA evaluates labels on a case-by-case basis to determine whether a specific advisory statement included along with a GF claim would be potentially misleading to the consumer”.
Two recent studies examined foods with and without GF labels to determine if an allergen advisory statement predicted contamination with wheat or gluten. The first, a 2016 retrospective review of 101 foods tested for gluten content through Gluten Free Watchdog, LLC, examined the product labels of foods not specifically labeled GF, but appearing to be free of gluten based on a thorough review of the ingredients list. Of the 101 products reviewed, 87 did not include an allergen advisory statement for wheat or gluten on the packaging. Of the 87 products without a statement, 13 contained quantifiable levels of gluten at or above 5 ppm, with 4 of those being at or above 20 ppm. Of the 14 products with an allergen advisory statement, 1 contained a quantifiable level of gluten (testing at or above 20 ppm).
The second study retrospectively examined the information from product packaging for 328 foods tested for gluten content through Gluten Free Watchdog, LLC that were labeled GF. Of the products reviewed, 297 did not include an allergen advisory statement for wheat or gluten on product packaging, while 31 did include a statement. Of the 297 products that did not include a statement, 39 contained quantifiable gluten at or above 5 ppm, with 12 of those testing at 20 ppm or above. Of the 31 products with an allergen advisory statement, 3 contained at or above 5 ppm gluten, including 2 that tested at or above 20 ppm.
The authors from these studies concluded that “the use of allergen advisory statements (regardless of type) on foods labeled GF was not indicative that a food was out of compliance with the GF labeling rule”.5 They also concluded that “due to the current lack of federal regulations for allergen advisory statements, consumers with celiac disease and other gluten-related disorders should not make GF purchasing decisions based solely on the presence or absence of an allergen advisory statement for wheat”.
Still, allergen advisory statements cause significant worry, and many patients on the GF diet continue to avoid products with these statements. To help alleviate these concerns, the FDA should strongly consider taking action by regulating these statements, such as requiring additional verbiage on product packaging such as “regardless of the presence of an allergen advisory statement for wheat, this product must comply with all criteria of the GF labeling rule”.5 Consumers with questions regarding allergen advisory statements should contact the manufacturer to inquire about precautions taken in facilities and on equipment; examples are found in Table 1.