FDA's warning letter to General Mills concerning cardiovascular health claims linked to Cheerios reflects a newly empowered agency and foreshadows aggressive regulatory activity to come, experts say.

In a May 5 letter to the Minneapolis-based food giant, FDA's district office says label claims touting the clinically proven ability of the toasted whole grain oat cereal to lower one's cholesterol make Cheerios an unapproved new drug for treatment of hypercholesterolemia.

The letter sends a message to food and dietary supplement manufacturers that make health claims to hew tightly to FDA's claims regulations and approved language, or else.

While the agency approved a claim for soluble fiber and heart disease reduction, the letter says claims General Mills made for years on Cheerios packaging cross the line.

The product label says, "You can lower your cholesterol 4% in 6 weeks" and cites a study showing two servings of Cheerios daily "reduced bad cholesterol when eaten as part of a diet low in saturated fat and cholesterol" - both examples of unapproved language, according to the letter, which FDA posted May 12.

While the approved version of the claim for soluble fiber and the reduction of heart disease risk appears on the box, FDA considers a separate reference to cholesterol reduction and the citation of a percentage in the study results separate claims.

The agency explains that cholesterol-lowering claims in this context are allowed only "as part of" the approved coronary heart disease claim.

FDA says the approved claim does not permit the company to "attribute any degree of risk reduction for coronary heart disease" to the cereal, as it does with its percentage cholesterol reduction language.

A General Mills spokesman said the "lower your cholesterol 4% in 6 weeks" claim is two years old and acknowledged that FDA "is interested in how the Cheerios cholesterol-lowering information is presented" on the package and Web site, rather than in disputing the firm's supporting science.

The company plans to meet with FDA to resolve the dispute, he added. FDA gives General Mills 15 days from receipt of the letter to inform the agency on the steps it took to correct the violations, or to explain any delay in completing the corrections.

Pushing The Envelope

The Center for Science in the Public Interest applauded FDA's action, calling the Cheerios label language "grossly exaggerated and misleading."

"The claims for Cheerios portrayed the cereal as a magic bullet" in reducing CHD risk, independent of the context required by the approved claim, said CSPI Director of Legal Affairs Bruce Silverglade in a statement.

Food and drug attorney Marc Ullman, of New York firm Ullman, Shapiro & Ullman, said General Mills' 12-year-old campaign for the heart health benefits of Cheerios uses claims that "push the envelope."

Not everyone believes FDA's pursuit of Cheerios is warranted or even appropriate under the statute.

A. Wes Siegner, of Washington-based law firm Hyman, Phelps & McNamara, noted that FDA is "trying to draw a line in the sand" with regard to overly assertive label claims, but added that the agency essentially is contesting semantic disparities between the approved claim and the Cheerios label.

"We're talking about words without really any difference of meaning in terms of science," he said.

"All General Mills is really doing is being more clear for the consumer to translate what the science means."

Jonathan Emord of Emord & Associates called the agency's action "ominous" in terms of freedom of speech issues. Emord served as lead counsel in several prominent cases against the FDA over nutrient claims, including Pearson v. Shalala.

FDA "is using bureaucratic strictures to block speech that is demonstrably true, elevating the regulation over the First Amendment," said Emord in an e-mail.

Another food and drug attorney who asked not to be identified agreed that FDA's approved CHD claim is "cumbersome" as worded and could confuse consumers.

He added that the Cheerios warning letter likely is indicative of FDA's enforcement direction, though not necessarily for good reason.

"This is not snake oil," he said. "Generally the data are pretty good to show cholesterol reduction with these kinds of products."

Giving The Nth Degree

The claim citing a degree of risk reduction for cholesterol and a claim on the Cheerios Web site linking whole grain consumption with reduction of risk for stomach and colon cancer are both impermissible degree claims, FDA says.

FDA does not object to the Web site claim linking a diet with whole grains to reduced cancer risk, but says a reference to "especially" stomach and colon cancers implies a degree of risk reduction.

Given that General Mills likely has data backing its reference to the two cancer types, Siegner said it is counterintuitive for FDA to disallow claims that merely seek to provide consumers with "more truthful information."

He maintained that the 4 percent cholesterol reduction claim also is consistent with the regulation, since the firm is not equating it with a degree of CHD risk reduction.

Still, Siegner said General Mills probably "will cave on this point, as it is not really necessary to the bigger message" the company seeks to make regarding Cheerios' heart health benefits.

Ullman said the influence of acting FDA Commissioner Josh Sharfstein appears in the warning letter, and conjectured that the agency will push more actions against industry to the courts, "as opposed to FDA's former policy of not litigating unless it knew it could win" (¹ Also see "Sharfstein Takes “Acting” Title Literally, Starting FDA Overhaul" - Pink Sheet, 13 April, 2009., p. 3).

- Dan Schiff (d.schiff@elsevier.com)

FDA Cheerios Warning Signals Tougher Stance On Health Claims Enforcement

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