The Food and Drug Administration has warned Cheerios that it will either have to stop promoting the cereal as reducing cholesterol by a certain percentage or face seizure and injunction against manufacturer General Mills.
That is because if it continues to maintain that the cereal can lower cholesterol by 4% in six weeks, the FDA says,
the government will consider the cereal a drug. Moreover, the agency would consider the cereal a new drug at that, which cannot be marketed at all without being submitted first for approval, according to a letter to the company on the FDA Web site.
Cheerios maker General Mills stood by the claim, but said it would work with the FDA to address its concerns.
The FDA letter, dated May 5, gives General Mills 15 days from receipt of the letter to correct the violations or face
"enforcement action without further notice," adding that "[e]nforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products."
The FDA points out in the letter that it has approved the claim that soluble fiber from whole grain oats, which Cherrios is made from, is associated with a reduced risk of coronary heart disease. The claim can also include that
Cheerios, for example, reduces that risk via lowering LDL cholesterol.
Where General Mills runs afoul of the rules is by including a percentage of reduction. The rules state that the claim cannot attribute any degree of risk reduction for heart disease, and the FDA considers LDL cholesterol (so called "bad" cholesterol) levels to be a "surrogate endpoint" for coronary heart disease.
In a statement, General Mills spokesman Tom Forsythe defended the cereal's claims.
"Cheerios' soluble fiber heart
health claim has been FDA-approved for 12 years, and Cheerios' "lower your cholesterol 4% in six weeks" message has been featured on the box for more than two years," he said. "The science is not in question. The scientific body of evidence supporting the heart health claim was the basis for FDA's approval of the heart health claim, and the clinical study supporting Cheerios' cholesterol-lowering benefit is very strong. The FDA is interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and Web site. We look forward to discussing this with FDA and to reaching a resolution."
At press time, the company was still promoting the cereal on its Web site as helping reduce cholesterol by 10% in one month.
The American Association of Advertising Agencies is in General Mills's corner over the issue.
"I don't understand the FDA's logic in issuing a warning letter to General Mills for their claims that Cheerios can lower your cholesterol," said Adonis Hoffman, senior vice president and counsel for the American Association of Advertising Agencies. "If the claim is truthful, not misleading and can be substantiated, what sense does it make to require a food product to be treated like a drug? Where does such a policy lead us when it comes to claims for healthful foods such as broccoli, milk, eggs, beef, oatmeal and many, many more?"
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