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IDFA Supports Voluntary Allergy Labeling Guidance

Jan 19, 2009

In comments filed last week with the Food and Drug Administration, IDFA agreed that agency guidance regarding allergen advisory statements, such as "may contain" statements, would be useful to the industry and consumers, as long as it remains flexible and voluntary. IDFA also encouraged FDA to conduct an allergen risk assessment to establish tolerance thresholds based on science that could be trusted and used by both the food industry and consumers.

"A consistent approach would allow consumers to understand the messages they see on the food labels," the comments state. "However, it's important that the guidance be flexible enough to allow for truthful statements that appropriately characterize the potential presence of allergens in a food or beverage."

FDA currently is developing a long-term strategy to help manufacturers use allergen advisory labeling that will convey a clear and uniform message and provide adequate information to consumers with food allergies. As part of the process, FDA issued a call for comments and held a public hearing last September to learn how manufacturers currently use advisory labeling for allergens and how consumers interpret different types of advisory labeling statements.

Many processors voluntarily use advisory labels on food products that don't intentionally contain allergenic ingredients but could contain allergenic protein as a result of cross contact in the plant. FDA, however, is concerned that current advisory statements might not be useful or appropriate. In the call for comments, the agency cited recent research findings that show many people with food allergies are increasingly ignoring advisory labeling and risking their health as a result.

IDFA believes that establishing threshold levels, along with analytical testing methods that could be validated by FDA or another authoritative body, would make the advisory statements more effective.

"Currently, without thresholds, there is a zero tolerance for allergenic protein, and ingredients are being labeled or eliminated at significant cost with an unknown health benefit," the comments state. "If thresholds were set that defined the levels at which advisory statements should be made, this would allow companies to make the most accurate and useful statements for their consumers."

The Food Allergen Labeling and Consumer Protection Act of 2004 (FALCPA) mandates allergen labeling for all labeled products containing any of the eight major food allergens: milk, eggs, fish, crustacean shellfish, tree nuts, wheat, peanuts and soybeans. These foods account for 90 percent of all food allergy reactions. In addition to requiring labeling, the act also directed FDA to study the use of advisory statements for food allergens.

IDFA worked with members of its Allergen Task Force to develop the comments. For more information, contact Michelle Matto, IDFA assistant director of nutrition and labeling, at or 202-737-4332.


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