FDA issues labeling violation warning letters

March 4, 2010

The U.S. Food and Drug Administration (FDA) has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act. The action follows an October 2009 statement by Commissioner of Food and Drugs Margaret Hamburg encouraging companies to review their labeling to ensure that they were in compliance with FDA regulations, and were truthful and not misleading.

In an open letter to industry dated March 3, 2010, Hamburg underscored the importance of providing nutrition information that consumers could rely on.

“Today, ready access to reliable information about the calorie and nutrient content of food is even more important, given the prevalence of obesity and diet-related diseases in the United States,” Hamburg said in the letter. She also expressed her hope that the warning letters would clarify the FDA’s expectations for food manufacturers as they review their current labeling. The violations cited in the warning letters include unauthorized health claims, unauthorized nutrient content claims, and the unauthorized use of terms such as “healthy,” and others that have strict, regulatory definitions.

Companies that received warning letters have 15 business days to inform the FDA of the steps they will take to correct their labeling.

Hamburg has made nutrition labeling a priority for the FDA. The warning letters are the agency’s most recent action to help improve consumers’ ability to make nutritious choices. The FDA soon will propose guidance regarding calorie and nutrient labeling on the front of food packages and plans to work collaboratively with the food industry to design and implement innovative approaches to front-of-package labeling that can help consumers choose healthy diets.

Press release