What is FDA doing?
FDA is issuing warning letters to 17 food manufacturers that the agency has identified as having labels on one or more of their products that violate the Federal Food, Drug, and Cosmetic Act (the act).
Why is FDA taking this action?
The agency had been receiving an increasing number of complaints that many food labels give a misleading picture of the health benefits of their products. In October 2009, Commissioner Margaret Hamburg announced that FDA would be examining a variety of food products to determine whether their labels violated the act and FDA’s corresponding regulations. Dr. Hamburg stated that FDA would be placing particular emphasis on claims and statements made on the principal display panel (PDP) of food products (often referred to as front-of-package (FOP) labeling). This is because FOP labels are used by companies to catch a hurried shopper’s attention; however, they often do not provide a full picture of the nutritional composition of the product. The agency wants to ensure that statements made on the PDP are truthful, meaningful, and useful in helping consumers make healthy food choices and construct healthy diets.
How did FDA identify the products that are the subject of the enforcement action we are taking?
FDA identified a variety of products primarily through complaints received by the agency and by informal market surveys conducted by agency personnel. The agency also examined the websites of manufacturers identified as making inappropriate claims.
What are the primary violations?
Violations included a wide variety of unauthorized health claims and nutrient content claims. Products also were identified that made nutrient content claims about one nutrient, such as trans fat, but failed to identify other nutrients, such as saturated fat, which were present in the products at very high levels. The agency also identified a large number of products for infants and children less than two years of age that had unauthorized claims on their labels. While FDA is not concerned about the safety of these infant and toddler food products, it is concerned that the labels make claims that are not authorized by FDA as appropriate for these children.
What is FDA’s expectation from the firms that received Warning Letters?
The companies that have received warning letters have 15 working days to inform FDA of the steps that they are or will be taking to correct their labels. The agency also anticipates that other firms will examine their food labels to ensure that they are in full compliance with food labeling requirements and make changes where necessary.
Will FDA continue to monitor the marketplace for similar violations?
Yes, FDA will continue to monitor the marketplace for similar food labeling violations and will take regulatory actions, such as those taken today, that it considers appropriate.