Milling & Baking News - May 19, 2009 - 9

Business

Cheerios labeling claims called
into question by F.D.A.
WASHINGTON - The Food and
Drug Administration on May 5 issued a warning letter to General
Mills, Inc. advising the Minneapolisbased company that the label and labeling of its Cheerios Toasted Whole
Grain Oat Cereal is in violation of
the Federal Food, Drug and Cosmetic Act. The company said it has made
its claim for an extended period of
time, the science behind the claim is
safe and representatives of the company are looking forward to discussing the wording with the F.D.A.
According to the F.D.A., the claims
made on the Cheerios packages are
such that the cereal is promoted in
a manner that the product could be
perceived as a drug.
The claims in question include
"You can Lower Your Cholesterol 4%
in 6 weeks" and "Did you know that
in just 6 weeks Cheerios can reduce
bad cholesterol by an average of 4%?
Cheerios is ... clinically proven to
lower cholesterol. A clinical study
showed that eating two 1½ cup servings daily of Cheerios cereal reduced
bad cholesterol when eaten as part of
a diet low in saturated fat and cholesterol."
"These claims indicate that Cheerios is intended for use in lowering
cholesterol, and therefore in preventing, mitigating, and treating
the disease hypercholesterolemia,"
the F.D.A. wrote in its May 5 letter.
"Additionally, the claims indicate
that Cheerios is intended for use in
the treatment, mitigation and prevention of coronary heart disease
through lowering total and 'bad'
(L.D.L.) cholesterol."
These intended uses, the F.D.A.
said, qualify Cheerios as a drug,
and therefore require that the product must not be marketed with such

claims in the United States without
an approved new drug application.
The F.D.A. also pointed out that
while it has issued a regulation authorizing a health claim associating

soluble fiber from whole grain oats
with a reduced risk of coronary
heart disease, the Cheerios claims
fail to meet the requirement because
the two claims about lowering cholesterol are not made as part of the
approved heart health claim in the
lower left corner of the box, but instead are presented as separate,
stand-alone claims through their location on the package and other label
design features.
"The cholesterol claim that mentions the clinical study is on the back
of the Cheerios box, completely separate from the health claim on the front
label," the F.D.A. said. "Although the
other cholesterol claim is on the same
panel as the authorized health claim,
its prominent placement on a banner
in the center of the front label, together with its much larger font size,
different background, and other text
effects, clearly distinguish it from the
health claim in the lower left corner."
The claims in question also violate

Lance to close Brent & Sam's
cookie plant in Arkansas
NORTH LITTLE ROCK, ARK. -
Lance Inc. has announced plans to
close a North Little Rock-based Brent
& Sam's cookie plant it acquired in
March 2008, according to an internal memo obtained and published
by ArkansasBusiness.com.
According to the memo, Lance will
close the facility between July 3 and
bakingbusiness.com / world-grain.com

July 25 and move all of the equipment and production to a manufacturing facility in Charlotte, N.C.,
where Lance is headquartered.
"Consolidating this operation
with the operations in Charlotte
creates significant opportunities to
reduce operating costs and improve
efficiencies," the company said in

the provisions of the soluble fiber health
claim in that they specifically attribute
a degree of risk reduction for coronary
heart disease, the F.D.A. said.
In addition to labeling on Cheerios, the F.D.A. took exception to the
manner in which General Mills has
branded the product on its www.
wholegrainnation.com web site. By
bearing the claim "Heart-healthy
diets rich in whole grain foods can
reduce the risk of heart disease,"
General Mills has failed to fully
convey the authorized health claim
that states "Diets rich in whole grain
foods and other plant foods, and low
in saturated fat and cholesterol, may
help reduce the risk of heart disease."
By omitting "other plants foods" the
F.D.A. said General Mills is not conveying that all these factors together
help to reduce the risk of heart disease, not just whole grains alone.
General Mills has 15 days from
the receipt of the letter to inform the
F.D.A. as to what steps it has taken
to correct the violations and ensure
they don't occur in the future. But
Tom Forsythe, a spokesman for General Mills, said "Cheerios' soluble
fiber heart health claim has been
F.D.A.-approved for 12 years, and
Cheerios' 'lower your cholesterol
4% in 6 weeks' message has been
featured on the box for more than
2 years. The science is not in question. The scientific body of evidence
supporting the heart health claim
was the basis for F.D.A.'s approval
of the heart health claim, and the
clinical study supporting Cheerios'
cholesterol-lowering benefit is very
strong. The F.D.A. 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
F.D.A. and to reaching a resolution."
The full letter is available at www.
accessdata.fda.gov/scripts/wlcfm/
recentfiles.cfm. MBN
the memo. "Leveraging the synergies of this consolidation will help
ensure the long-term viability of
this premium cookie business."
Brent Bumpers, one of Brent &
Sam's founders, told ArkansasBusiness.com that by consolidating operations Lance should be
able to improve its relationship
with big retailers, such as WalMart Stores, Inc. and Target Corp.,
where Brent & Sam's cookies are
distributed. MBN
Milling & Baking News

May 19, 2009 / 9

http://www.wholegrainnation.com http://accessdata.fda.gov/scripts/wlcfm/ http://www.Business.com http://www.ArkansasBusiness.com http://www.bakingbusiness.com http://www.world-grain.com

Milling & Baking News - May 19, 2009

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