2nd UPDATE:FDA Warns General Mills On Cheerios Cereal Labels
May 12 2009 - 5:55PM
Dow Jones News
The U.S. Food and Drug Administration warned General Mills Inc.
(GIS) that labeling for its popular Cheerios-brand cereal contains
"serious violations" of federal law relating to claims about the
product's ability to lower cholesterol.
In a May 5 warning letter sent to the company and posted on the
FDA's Web site Tuesday, the agency said statements that the product
is "clinically proven to help lower cholesterol actually cause the
product to be a drug under federal law.
The FDA said cholesterol-lowering claims can only be made if the
product were to be approved as a drug. The product label says
Cheerios can lower cholesterol by 4% and cited a clinical study
involving the product as part of a diet low in saturated fat and
cholesterol. The FDA said Cheerios "can't be legally" marketed with
claims it lowers cholesterol by a certain percentage without an
approved new drug application.
"We try to make a bright line here between what can be said
about a drug and what can be said about a food," said Stephen
Sundlof, the director of FDA's Center for Food Safety and Applied
Nutrition. He explained that certain claims for a possible
reduction in heart-disease risk from eating whole grain foods is
allowed as long as specific language is used.
While Sundlof said "there's no specific campaign" to go after
food manufacturers, he said the agency is noticing a "tendency" of
more food companies crossing the line into the drug arena by adding
additional health claims on product packaging which could spark
more warning letters.
The FDA also took issue with a company-sponsored Web site
mentioned on the Cheerios box. The Web site discusses the benefits
of eating whole grains, but the FDA said some of the health claims
about reducing cancer and heart-disease risk don't comply with
agency rules regarding health claims for whole grains.
In a statement, General Mills spokesman Tom Forsythe said, the
message saying "lower your cholesterol 4% in 6 weeks" has been
featured on the box for more than two years and claims about heart
health have been FDA-approved for 12 years.
"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," he said. Forsythe said the company,
however, would work with the FDA to reach a solution on product
labeling.
The FDA said General Mills must "promptly" correct the
violations outlined in the letter or the agency could take
enforcement action, such as seizing products.
Sundlof said the FDA's review of Cheerios was prompted by a
September 2008 letter from the National Consumers League that asked
the FDA to look into its concerns about the Cheerios labeling on
cholesterol.
Last month the Federal Trade Commission settled a complaint with
Kellogg's involving claims that its Frosted Mini-Wheats cereal was
clinically shown to improve children's attentiveness by nearly 20%.
FTC Chairman Jon Leibowitz said the commission would start paying
more attention to national advertisers.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com