FDA Calls on Food Cos. to Correct Labeling Violations; Issues Open Letter to Industry

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. Most of the agency’s letters accuse the food companies of overstating or misstating the nutritional value of their products.

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 they were in compliance with FDA regulations.

In an open letter to the food 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, which also expressed her hope that the formal warning would clarify 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.

Hamburg has made nutrition labeling a priority for FDA, whose most recent action aims to aid consumers’ ability to make nutritious choices. The agency says it will soon 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.

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

Consumer groups, such as the Washington-based Center for Science in the Public Interest (CSPI) cheered the action by the FDA, which it said “should send a loud and clear signal to industry that time is running out on misleading health-related claims on labels,” in the words of the group’s legal affairs director Bruce Silverglade. “For far too long, manufacturers have exaggerated the healthfulness of their products, or even implied that their products contain special ‘functional’ ingredients that provide drug-like protection against various diseases.”

In addition to issuing industrywide regulations to halt misleading claims, CSPI also called on FDA to update the 20-year-old Nutrition Facts label and improve the readability of ingredient lists while it continues to study various schemes for providing key pieces of nutrition information prominently on front labels.

“The warning letters sent by FDA … are a welcome step,” said Silverglade. “But unless the FDA uses its authority to issue new, industrywide regulations to prevent such abuses, the agency will forever be playing a game of Whack-A-Mole with companies that use deceptive labeling.”

A list of the companies that received warning letters from the FDA can be found at www.fda.gov/Food/LabelingNutrition/ucm202784.htm.
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