March 3, 2010, the FDA announced that it had issued warning letters to 17 food manufacturers, stating that the companies have violated the Food, Drug, and Cosmetic Act (FDCA) by making misleading or unsubstantiated claims on food labels for 22 different products. The simultaneous issuance of a large number of warning letters has been described as “a shot across the bow” to the food industry and a signal that the FDA intends to make good on its promise to crack down on food manufacturers and improve food information for consumers. This is one part of the FDA's increased enforcement initiative against companies that are marketing allegedly violative FDA-regulated products. Just one day before announcing the issuance of the warning letters, the FDA released the results of the 2008 U.S. Health and Diet Survey, noting that consumers are skeptical of industry claims such as “low fat,” “high fiber,” or “cholesterol free” on the front of packages.
Nutritional Label Warning Letters
Several of the warning letters alleged violations of rules about highlighting the presence or absence of certain nutrients and about fat content claims. For instance, the FDA noted that companies such as Gorton's, Inc., Dreyer's Grand Ice Cream, The Schwan Food Company, and Spectrum Organic Products claim on product labels that the products contain no trans fat, even though the products contain saturated fat — sometimes close to the recommended daily intake in just one serving. In one letter, the FDA objected to a company's claims that one of its toddler foods is a “good source of iron, zinc, and Vitamin E,” based on the FDA's position that such claims generally are not permitted on products intended for children younger than two years old, since appropriate dietary levels have not been established for children in that age range. The FDA also warned about impermissible “lower sugar content” claims made on the packaging of certain juice products, also intended for children younger than two years old.
Other warning letters issued by the FDA called food manufacturers to task for making claims that their products may help treat some diseases. For example, the FDA alleged that POM Wonderful, LLC makes claims that its pomegranate juice products play a part in treating or preventing diseases such as prostate cancer, hypertension, atherosclerosis, and diabetes. The FDA warning letter asserted that promoting a product with such claims causes the product to be a drug under the FDCA, 21 U.S.C. Sec. 321(g)(1)(B) (“the term drug means … articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease.”) The FDA also found fault with claims made on some Diamond Foods, Inc. walnut packaging, which, the FDA alleged, suggest that the food can inhibit tumor growth, lower cholesterol, and treat depression. In May 2009, the FDA issued a similar warning letter to General Mills, Inc., stating that it made misleading claims on the label of Cheerios Toasted Whole Grain Oat Cereal about the food's ability to lower cholesterol, rendering that product a drug under the FDCA.
In addition to issuing the warning letters, FDA Commissioner Margaret A. Hamburg released an open letter to the food industry, stating that she intends to work with industry to design a “front-of-pack” labeling system to help consumers better understand nutritional information. In her letter, Commissioner Hamburg explained that the FDA is taking an aggressive stance on nutritional claims because “ready access to reliable information about the calorie and nutrition content of food” is important, particularly in light of the “prevalence of obesity and diet-related disease in the United States.” She said the FDA soon will issue new draft guidance on front-of-pack labeling that would “recommend nutritional criteria for foods that make ‘dietary guidance' statements (such as ‘Eat two cups of fruit a day for good health') in their labeling.” She urged food industry stakeholders to contribute their views on the draft guidance when it is released.
The FDA issued the warning letters to the 17 food manufacturers on February 22, 2010 and gave them 15 days to respond with an explanation of how they intend to change and correct their labels. The warning letters and the open letter may be accessed at http://bit.ly/bD9Z74.
2008 U.S. Health and Diet Survey
The day before it announced the issuance of the warning letters to food manufacturers, the FDA released the results of the 2008 U.S. Health and Diet Survey. The FDA has been conducting periodic surveys since 1982 to help gauge the U.S. adult population's “self-reported behaviors, knowledge, attitudes and beliefs about health and diet.”
In the most recent survey, the FDA found that a majority of consumers read food labels and are aware of the link between good nutrition and reducing the risk of disease. Almost two-thirds of adults are aware of the link between trans fats and heart disease and more than 90 percent are aware of the link between diet generally and heart disease. The survey also reports differing degrees of trust about claims found on food labels. As an example, 41 percent of consumers believe that all or most of claims such as “low fat,” “high fiber,” or “cholesterol free” are accurate, while 56 percent believe that some or none of them are accurate. The full results of the U.S. Health and Diet Survey may be accessed at http://bit.ly/9ESi1V.
The FDA's recent aggressive actions against 17 food manufacturers for allegedly making misleading claims on their labels, coupled with the FDA's similar action last year against General Mills, signals that the FDA is likely to expend increased energy and resources policing nutritional claims. In light of the FDA's action and focus in this area, companies should consider reviewing their product labeling and revising them accordingly. Foley will continue to provide updates on nutritional label developments and other important FDA-related topics.