UPDATE: FDA Warns General Mills On Cheerios Cereal Labels
May 12 2009 - 11:53AM
Dow Jones News
The U.S. Food and Drug Administration warned General Mills Inc.
(GIS) that labeling that makes certain health claims for Cheerios
whole-grain oat cereal contains "serious violations" of agency
rules.
In a May 5 warning letter sent to the company and posted on the
FDA's Web site Tuesday, the agency said statements made on the
product's label about Cheerios' ability to lower cholesterol cause
the product to be a drug under agency regulations.
The FDA said claims made on the product's package stating that
Cheerios is clinically proven to lower cholesterol 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.
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.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com