Cheerios: Food or drug?

I t seemed like a joke at first: Cheerios is a drug. Yet when the Food and Drug Administration warned General Mills recently that health claims on Cheerios packaging went too far, claims that essentially turned the nation's No. 1 breakfast cereal into a medicine, it was a turnaround from what's long been regarded as the FDA's permissive attitude on food packaging health claims.

The warning was serious enough that the company and FDA regulators are now meeting to find a resolution, but it hasn't resulted in any changes to Cheerios advertising -- yet.

Health claims have become a food marketing priority at major food companies like General Mills, which in the past four years has made health improvements of one kind or another to some 45 percent of its U.S. retail portfolio -- things like Yoplait yogurt, Nature Valley granola bars, Progresso soup, Hamburger Helper and Gold Medal flour.

"Health benefits, very broadly speaking, are very meaningful to consumers," said Ken Powell, CEO of General Mills.

He cited the company's development of the Fiber One bar, a product essentially built around a health claim, and the fast rise of its $200 million Progresso Lite soup business, launched just a couple of years ago.

The relatively recent arrival of functional foods -- things that carry specific health benefits -- has unleashed a wave of health claims, from the benefits of pomegranate juice to whole grains.

"If you go to Whole Foods and look in the vitamins section, a lot of the vitamins will make claims," said David Hopkins, marketing professor at the Carlson School of Management at the University of Minnesota. "Because of the research that's come out on all of these ingredients, a lot of companies will try to take advantage, not nefariously, that there are health benefits to these foods. It's just how far will you push it?"

Many products on store shelves today make questionable claims, Hopkins said, pointing to the pomegranate juice company with an advertisement that shows a bottle of its product next to the words "Cheat death."

In the food industry "misleading health-related claims on food labels is a major, major problem," said Bruce Silverglade, legal director for the Center for Science in the Public Interest (CSPI), which has filed lawsuits against companies over misleading labels.

Education to advertising

Health claims were not closely regulated before Congress passed the Nutrition Labeling and Education Act of 1990, which allowed certain claims but also reinforced the FDA's authority to monitor food labels.

The original law said health claims must be approved by the Food and Drug Administration and must also be supported by science, or "significant scientific agreement."

But there's been a steady erosion of that law as food companies have lobbied the FDA to allow more specific health claims -- ones that could be used in advertising specific foods, rather than for educational purposes, as was originally intended, Silverglade said.

Then in 2003 the rules were further loosened when the FDA allowed some health claims even if they were not supported by significant scientific agreement. Nor does the FDA review and approve all health claims before they appear in the marketplace, said an agency spokeswoman.

"The original health claims authorized by Congress morphed into purely marketing messages that portrayed individual foods as magic bullets," said Silverglade.

The FDA has issued thousands of warning letters to companies nationwide for everything from poor handling of seafood to adulterated drugs. General Mills' warning over Cheerios labeling is its first in at least a decade.

Cheerios isn't the first oat-based food to run into trouble with health claims: Two years ago, after questions from the CSPI, Quaker Oats dropped advertising on some of its oatmeal products that said the oatmeal "actively finds" and removes cholesterol within a consumer's body. The company also removed a graph from its packaging that the CSPI said greatly exaggerated the cholesterol-lowering potential of oatmeal.

Given the number of claims screaming from packages at any grocery store, Hopkins found the FDA's recent Cheerios stance interesting.

"The claims on the Cheerios box has been around for a while," Hopkins said "The FDA took a tighter stance and went for a higher profile company."

Four percent in six weeks

Under the labeling laws, Cheerios may make the claim that it can lower the risk of coronary heart disease when eaten as part of a diet low in saturated fat and cholesterol, the FDA says.

The law allows food manufacturers to make a second claim that specifically mentions a certain food, for Cheerios it's oats or "whole-grain foods," as long as it's made as part of the more general claim about soluble fiber.

The FDA's May 5 warning letter spells out "serious violations" of the Food, Drug and Cosmetic Act, adding that the statement that Cheerios can "lower your cholesterol 4 percent in six weeks," drew specific concern, as did more general claims about how consumption of Cheerios is "clinically proven to lower cholesterol."

The box also broke the rules, according to the FDA, because the second, more specific claim about Cheerios is in large type in the center of the box while the more generic claim about diets low in saturated fat is in smaller type near the bottom of the box.

"The claim is misleading because Cheerios alone don't lower cholesterol," said Silverglade. "You still need a diet low in cholesterol."

General Mills defends its bestseller. "The discussion that we're having with [the FDA] is around a specific claim, that made a percentage claim, which is very strongly supported by the science," said CEO Powell in an interview last week. "Our goal is to be very responsive to the questions and resolve the labeling question, and I'm sure we'll be able to do that."

"As a family, we like it," Minneapolis resident Ali Aden said of Cheerios, as he shopped Thursday at a Minneapolis Rainbow Foods.

"My wife likes it because of what they say" about cholesterol, he said, pointing to the banner across the front of the Cheerios box proclaiming a 4 percent drop in cholesterol in six weeks. "I never read that part," he said, spying the less visible, more generic health claim along the bottom of the package. "That's very tricky."

If no resolution is worked out, the FDA could set up a regulatory meeting, seize products (as was done in 1992 when concentrate orange juice was labeled as "fresh") file an injunction or prosecute.

"The option we choose will be based in part on the nature of the violation," said an FDA spokeswoman.

Matt McKinney • 612-673-7329