FDA Warns General Mills On Cheerios Cereal Labeling
13 May 2009 - 1:07AM
Dow Jones News
The U.S. Food and Drug Administration warned General Mills Inc.
(GIS) that the labeling for Cheerios whole-grain oat cereal
contained "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 the health claims 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 "bad" 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.
A General Mills spokesperson wasn't immediately available to
comment on the letter.
The FDA said General Mills must "promptly" correct the
violations outlined in the letter, otherwise the agency could take
enforcement action such as seizing products.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com