U.S. objects to General Mills' Cheerios health claims

WASHINGTON (Reuters) - General Mills made unauthorized claims about the heart-related benefits of Cheerios on cereal boxes and a website, U.S. regulators said in a letter released on Tuesday.

The U.S. Food and Drug Administration said it considered language about cholesterol-lowering benefits on boxes of Cheerios Toasted Whole Grain Oat Cereal to be unapproved drug claims.

The language and presentation did not qualify under the government's approved claims linking fiber from whole grain oats with a reduced risk of heart disease, the May 5 letter said.

Companies are not allowed to claim a specific degree of risk reduction, the FDA said. The Cheerios box, however, said consumers could "lower your cholesterol 4 percent in six weeks."

That message has been featured on the Cheerios box for more than two years and the science supporting the claims "is not in question," General Mills spokesman Tom Forsythe said.

"The clinical study supporting Cheerios' cholesterol-lowering benefit is very strong," he said.

Forsythe said the FDA was "interested in how the Cheerios cholesterol-lowering information is presented on the Cheerios package and website. We look forward to discussing this with FDA and to reaching a resolution."

The FDA said a General Mills website, www.wholegrainnation.com, also made unauthorized claims about Cheerios and a reduction of heart disease and cancer.

In its warning letter, the FDA told General Mills to detail how it would correct the violations within 15 days.

The FDA sends dozens of warning letters each year. Most issues are resolved without further action, but the letters can lead to product seizures and other penalties.

The letter was posted on the FDA website here

(Reporting by Lisa Richwine and Brad Dorfman; Editing by Tim Dobbyn)