On August 2nd, 2013, The U.S. Food and Drug Administration issued a new regulation defining gluten-free food labeling.The rule guarantees that gluten-free packaged food claims are trustworthy and contains less than 20 ppm (parts per million) gluten. This is the lowest level that can be consistently identified in foods using valid scientific analytical tools. Manufacturers that claimed to produce “gluten-free”, “no gluten”, “without gluten” and “free of gluten “products had one year to make the necessary changes in their formulation and labeling of their foods.
Why is the FDA regulating gluten-free labeling on food?The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) directed HHS to define and permit the use of the term “gluten-free” in the labeling of foods. In 2007, the FDA published a proposed rule. The proposal defined the term “gluten-free” as that the food must contain less than 20 parts per million of gluten. The FDA announced to conduct a safety assessment for gluten with those suffering from celiac disease. In August 2011, FDA reopened the comment period on the proposal. After reviewing and considering the comments, the FDA announced its final rule in August 2013.
How does FDA characterize Gluten-Free?In 2014, the FDA allows producers to label a food gluten-free if the food does not have any of the following:
• An ingredient that is any type of wheat, barley, rye 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 of gluten.
Foods such as vegetables, fruits, bottled water and eggs can be labeled gluten-free as they naturally do not have any gluten.
In addition, if a food label includes “gluten free” and the word “wheat” (it lists a wheat ingredient that has been processed to eliminate gluten in its ingredient list) then the word “wheat” has to follow with an asterisk that states the following declaration: “The wheat has been processed to allow this food to meet the Food and Drug Administration (FDA) requirements for gluten-free foods.”
What kind of foods does the regulation apply to?The rule applies only to FDA regulated human foods- which includes dietary supplements. Food for animals is excluded as well as meat, poultry and eggs which are regulated by the USDA. Likewise, alcoholic beverages are also excluded and are labeled by TTB (Tobacco Tax and Trade Bureau).
Where should the gluten-free claim appear on the food label?The final rule does not require manufacturers to place the voluntary gluten-free claim in any exact location on the food label. Producers may choose where they place a gluten-free claim on their food labels, as long as the claim does not interfere with FDA mandatory labeling information and meets all regulatory requirements. Also, no particular color is required for the label.
Should foods that are naturally free of gluten be labeled “gluten-free”?If the food is manufactured to be free of gluten or it occurs to be naturally free of gluten, for instance, bottled spring water, a gluten-free label claim is allowed as long as it meets all FDA requirements for a gluten-free food. The claim is voluntary.
Are statements such as: “made with no-gluten containing ingredients”, “not made with gluten containing ingredients “or “made in a factory that processes wheat products” allowed gluten-free labeling?Yes, the above statements are allowed on food labels as long as the manufacturer is adhering to the FDA’s final rule requirements and the statement is truthful and not misleading to the consumer.
Will food need to be tested in order for the gluten-free claim to be on the food label?Under the new rule, manufacturers are not required to test for the presence of gluten in their starting ingredients or finished foods that are labeled “gluten-free”. But, the manufacturer will be responsible that foods claiming to be “gluten-free” are complying with the regulations set by the FDA which include any unavoidable gluten that is present to be under the 20 ppm.
The FDA encourages companies to take the necessary actions to make sure they are complying with the requirements by:
• Testing the ingredients to make sure what their gluten content is
• Requesting gluten analysis certificates from ingredient suppliers
• Participate in a third-party gluten-free certification program
Furthermore, the FDA identifies two ELISA (enzyme-linked immunosorbent assay) methods that the agency can use for compliance purpose. They are as following: R5-Mendez Method or Morinaga Method.
Will restaurants comply to the new rule?The FDA also recognizes that individuals suffering from celiac disease are also concerned with being able to identify gluten-free foods that are served in restaurants. The gluten-free rule applies to packaged foods, which may also be sold in some food establishments. The FDA stated that restaurants that claim gluten-free foods on their menu must adhere with the FDA’s definition of gluten-free.
How will the FDA monitor manufacturers that are claiming “gluten-free” products?The FDA will continue to periodically inspect food manufacturing facilities, sample, perform laboratory analysis, issue warning letters, remove and/or ban products that do not comply with the definition of “gluten-free”.
FDA Commissioner Margaret A. Hamburg stated that, “the FDA’s new “gluten-free” definition will help people with this condition make food choices with confidence and allow them to better manage their health.”
The FDA warns consumers that some of the existing foods on the shelves may have been labeled “gluten-free” before the rule’s compliance date of August 5, 2014. Some foods have a longer shelf life, such as pasta, and may legally stay on the shelves longer.
Consumers that have questions about a products ingredient should contact the manufacturer or check its website for more information.