FDA Cites Food Firms on Labeling Violations; Commissioner Hamburg Issues Open Letter on Labeling to the Industry

March 3, 2010

The U. S. Food and Drug Administration announced today that it has issued Warning Letters to 17 food manufacturers informing them that labeling for 22 of their products violates the Federal Food, Drug, and Cosmetic Act.

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 for which regulatory definitions have been established to assure that such claims are reliable.

The action follows an October 2009 statement by Commissioner of Food and Drugs Margaret Hamburg, M.D., 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 issued today, Dr. Hamburg underscored the importance of providing nutrition information that consumers can rely on, and expressed her hope that the Warning Letters would clarify the FDA’s expectations for food manufacturers as they review their current labeling.

Dr. 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 food choices. The FDA soon will propose guidance regarding nutrition 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.

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

Copies of the Warning Letters, Dr. Hamburg's Open Letter to Industry, and other information are available.