Food labeling is required for most prepared foods, such as breads, cereals, canned and frozen foods, snacks, desserts, drinks, etc. Nutrition labeling for raw produce (fruits and vegetables) and fish is voluntary. We refer to these products as “conventional” foods.
Under the leadership of Commissioner of Food and Drugs Margaret Hamburg, M.D., reliable nutrition labeling of food products is a top priority for the Food and Drug Administration. In a recent statement, Dr. Hamburg encouraged food companies to review their labeling to ensure that they were in compliance with FDA regulations, and were truthful and not misleading.
In addition, the U.S. Food and Drug Administration has notified 17 food manufacturers that the labeling for 22 of their food products violates the Federal Food, Drug, and Cosmetic Act.
“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,” Dr. 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.
FDA soon will propose guidance for the industry 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.
Nutrition Initiative Questions & Answers
Why is FDA taking this action?
How did FDA identify the products that are the subject of the enforcement action we are taking?
What are the primary violations?
What is FDA’s expectation from the firms that received Warning Letters?
Will FDA continue to monitor the marketplace for similar violations?


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