The FDA Asks: How Would You Improve Gluten Warnings On Food Labels?

Here’s a chance to give the U.S. Food and Drug Administration (FDA) your opinion about how food labeling could be changed to be more useful for people with celiac disease or food allergies. On September 16th, the FDA will hold a public hearing on "Use of Allergen Advisory Labeling: Its Use, Effectiveness, and Consumer Perception.”

If you can’t attend in person, you can still participate by submitting your answers to the FDA’s questions, either electronically or in writing. Indicate that the Docket # is FDA-2008-N-0429. Written comments should be sent to: Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. The deadline for comments is January 14, 2009.

The full list of issues and questions appears in the Federal Register. In part, the FDA is asking:

Currently, industry uses many different advisory statements, such as "May contain (allergen)," "(allergen) traces,'' "Produced on shared equipment that processes (allergen),'' and "Produced in a plant that processes (allergen)." We are concerned that allergic consumers may be risking their health by ignoring labeling designed to inform them of the potential presence of allergens in foods. To help us better understand what type of advisory labeling is most effective in helping consumers avoid adverse allergic reactions, we ask the following questions:

...What specific advisory statements adequately inform consumers of the potential risk of cross-contact with allergenic materials? What advisory statements most accurately communicate to consumers and their caregivers the potential risk of the presence of the allergen? Why?

...If you are a food-allergic consumer or caregiver to such a consumer, do you ever ignore advisory statements? If so, which types of statements, and why?

...In addition to the information and data mentioned in this document, what additional information or data are available that would assist us in understanding consumers' perceptions of, use of, and need for specific advisory statements and advisory labeling in general?

The FDA is assessing how advisory statements should be worded to be the most effective in communicating the likelihood that an allergen may be present in a food. Consumer focus group research shows that the elements essential for an effective warning or safe handling statement are: a description of the hazard, handling instructions for avoiding the hazard, and an instructional statement that describes conditions under which the hazard occurs and what action to take if the hazard is not avoided… This same research indicates that label messages are more credible when consumers know the reason for the message….To help us better understand how advisory statements should be worded to be the most effective in communicating the likelihood that an allergen may be present in a food, we ask the following questions:

...What elements are needed in an advisory statement to adequately inform consumers of the potential for the inadvertent presence of an allergen and would communicate to allergic consumers a consistent and effective message regarding the risk of consuming the product?

For more information about the FDA's upcoming hearing, visit the website of the American Celiac Disease Alliance.

For more information about U.S. food labeling regulations, read The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA): What FALCPA Means For Gluten-Free Shopping.