Cheerios and the FDA
In the News
May 25, 2009
Cheerios has been promoting their heart healthy, whole grain oat cereal for years, and for the past two years, cited a clinical study that highlighted the product’s cholesterol lowering effects. The FDA – following up on a complaint from a consumer organization – found the claims to be in serious violation of the Federal Food, Drug and Cosmetic Act.
The history of FDA-approved health claims goes all the way back to the 1980s, when food marketing strategists started taking advantage of the relationship between sales and the role of nutrition in promoting health. Without regulation, some claims used at the time were considered misleading. The 1990 Nutrition Labeling and Education Act (NLEA) was intended, in part, to eliminate misleading claims and only authorize claims supported by significant scientific agreement.
There are currently 12 authorized health claims, ranging from "soluble fiber may help reduce risk of coronary heart disease" to "calcium may help reduce risk of osteoporosis." These allowed claims are intended to show a relationship between a food, like whole grain, and a disease or health-related condition. One regulation authorizes a health claim associating soluble fiber from certain foods, including oats, with a reduced risk of coronary heart disease – a claim that Cheerios has made in the past.
But the recent claims of “you can Lower Your Cholesterol 4% in 6 weeks,” says the FDA, did not follow these guidelines since these claims indicated a degree of disease risk reduction. The FDA also took issue with some of the statements on the General Mills Cheerios website. One such statement – “heart-healthy diets rich in whole grain foods can reduce the risk of heart disease” – was considered a misbranded health claim because the claim leaves out references to fruits, vegetables, fiber content, and to keeping the levels of saturated fat and cholesterol levels in the diet low.
Without including all of these other, related factors, says the FDA, consumers would not be able to understand the significance of the product in the overall daily diet. Other similar violations were noted in a warning letter from the FDA to Cheerios CEO Ken Powell.
“The scientific body of evidence supporting the heart health claim was the basis for FDA’s approval of the claim and the clinical study supporting Cheerios’ cholesterol-lowering benefit is very strong,” says Tom Forsythe, a spokesman for General Mills. “The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website. We are in dialog with FDA, and we look forward to reaching a resolution.”
Susan Cruzan, spokesperson for the FDA, says that the bottom line is that these health claims are based on significant scientific agreement, which includes conditions for the use of the claim, and that General Mills was crossing over into the arena of drug claims.
“When a product says that it can be used to treat or mitigate a health condition, it is stepping over the line from health claim to drug claim,” Cruzan says. “Health claims are intended to show how using a product can reduce the risk of disease when used along with a healthy diet.”
Wendy Reinhardt Kapsak, Director of Health and Nutrition for the International Food Information Council (IFIC) and IFIC Foundation, says that consumers do not necessarily differentiate among the various forms of claims, be them health claims or claims about structure and function – and that they are not aware of the legal nuances involved when getting labels approved for packaging. What consumers do appreciate, she says, are messages about foods and health that are positive overall.
“Our research indicates that consumers perceive certain products as healthful, regardless of the language used in the claim,” says Reinhardt Kapsak. “The food label is only one way to communicate the health benefits of various foods and beverages to consumers. Consumers appreciate hearing the same message from multiple sources.”