Re: WARNING LETTER

Beast:

GTH!


The Cyberstalking Beast FTBL Image:
http://www.collectiondx.com/gallery2/gallery/d/53247-5/1.jpg


On Oct 11, 2:47 pm, Happy Oyster <happy.oys...@xxxxxxxxxxx> wrote:
On Sun, 11 Oct 2009 12:08:09 -0700 (PDT), rpautrey2 <rpautr...@xxxxxxxxx> wrote:
Grandiose delusions
From Wikipedia, the free encyclopedia

Ralph Paul Autrey, Jr, a shill for Hulda Clark, talks about delusions. What a
schizophrenia. ;O)

Now, here is some serious stuff:

<quote>
Cheerio, my dear bread! The FDA punches cereal fraudvertizing

[*QUOTE*]
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FDA Home Page | Search FDA Site | FDA A-Z Index | Contact FDA

Department of Health and Human Services
Public Health Service
Food and Drug Administration

Minneapolis District Office
Central Region
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7114
FAX: (612) 3344142

May 5,2009

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Refer to MIN 09 -18

Ken Powell
Chairman of the Board and CEO
General Mills
One General Mills Boulevard
Minneapolis, Minnesota 55426

Dear Mr. Powell:

The Food and Drug Administration (FDA) has reviewed the label and labeling of
your Cheerios® Toasted Whole Grain Oat Cereal. FDA's review found serious
violations of the Federal Food, Drug, and Cosmetic Act (the Act) and the
applicable regulations in Title 21, Code of Federal Regulations (21 CFR). You
can find copies of the Act and these regulations through links in FDA's home
page athttp://www.fda.gov.

Unapproved New Drug

Based on claims made on your product's label, we have determined that your
Cheerios® Toasted Whole Grain Oat Cereal is promoted for conditions that cause
it to be a drug because the product is intended for use in the prevention,
mitigation, and treatment of disease. Specifically, your Cheerios® product bears
the following claims ort its label:

• "you can Lower Your Cholesterol 4% in 6 weeks" "
• "Did you know that in just 6 weeks Cheerios can reduce bad cholesterol by an
average of 4 percent? Cheerios is ... clinically proven to lower cholesterol. A
clinical study showed that eating two 1 1/2 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. 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" (LDL) cholesterol. Elevated levels of
total and LDL cholesterol are a risk factor for coronary heart disease and can
be a sign of coronary heart disease. Because of these intended uses, the product
is a drug within the meaning of section 201(g)(1)(B) of the Act [21 U.S.C.. § 321
(g)P)(B)]. The product is also a new drug under section 201(p) of the Act [21
U.S.C. § 321(p)] because it is not generally recognized as safe and effective
for use in preventing or treating hypercholesterolemia or coronary heart
disease. Therefore,under section 505(a) of the Act [21 U.S.C. § 355(a)], it may
not be legally marketed with the above claims in the United States without an
approved new drug application.

FDA has issued a regulation authorizing a health claim associating soluble fiber
from whole grain oats with a reduced risk of coronary heart disease (21 CFR
101.81). Like FDA's other regulations authorizing health Claims about a food
substance and reduced risk of coronary heart disease, this regulation provides
for the claim to include an optional statement, as part of the health claim,
that the substance reduces the risk of coronary heart disease through the
intermediate link of lowering blood total and LDL cholesterol. See 21 CFR
101.81(d)(2),-(3). Although the lower left corner of the Cheerios® front label
contains a soluble fiber/coronary heart disease health claim authorized under 21
CFR 101.81, the two claims about lowering cholesterol are not made as part of
that claim but rather 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. 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.

Additionally, even if the cholesterol-lowering claims were part of an otherwise
permissible claim, under 21 CFR 101.81, the resulting claim language still would
not qualify for the use of the soluble fiber health claim. To use the soluble
fiber health claim, a product must comply with the claim specific requirements
in 21 CFR 101.81, including the requirement that the claim not attribute any
degree of risk reduction for coronary heart disease to diets that include foods
eligible to bear the claim. See 21 CFR 101.81(c)(2)(E). However, the label of
your Cheerios® cereal claims a degree of risk reduction for coronary heart
disease by stating that Cheerios® can lower cholesterol by four percent in six
weeks. High blood total and LDL cholesterol levels are a surrogate endpoint for
coronary heart disease; therefore, the cholesterol-lowering claims on the
Cheerios® label attribute a degree of risk reduction for coronary heart disease
because if total and LDL cholesterol levels decline, the risk of coronary heart
disease declines as well.

Misbranded Food:

Your Cheerios ® product is misbranded within the meaning of section 403(r)(1)(B)
of the Act [21 U.S.C. § 343(r)(1)(B)] because it bears unauthorized health
claims in its labeling. We have determined that your websitewww.wholegrainnation.comis labeling for your Cheerios® product under section
201(m) of the Act [21 U.S.C. § 321 (m)] because the website address appears on
the product label. This website bears the following unauthorized health claims:

"Heart-healthy diets rich in whole grain foods, can reduce the risk of heart
disease."

This health claims misbrands your product because it has been authorized either
by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. §
343(r)(3)(A)(B)]] or under authority of the health claim notificati6n provision
of the Act [see section'343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(G)]].
Although FDA has issued a regulation authorizing a health claim associating
fiber-containing grain products with a reduced risk of coronary heart disease
(21 CFR 101.77), the claim on your website does not meet the requirements for
this claim. For example, under section 101.77(c)(2), the claim must state that
diets low in saturated fat and cholesterol and high in fiber-containing fruit,
vegetable, and grain products may reduce the risk of heart disease. The claim on
your website leaves out any reference to fruits and vegetables, to fiber
content, and to keeping the levels of saturated fat and cholesterol in the diet
low. Therefore, your claim does not convey that all these factors together help
to reduce the risk of heart disease and does not enable the public to understand
the significance of the claim in the context of the total daily diet (see
section 343(r)(3)(B)(iii) of the Act [21 U.S.C.§ 343(r)(3)(B)(iiill].

In addition to the health claim authorized by regulation in 21 CFR 101.77, other
health claims linking the consumption of whole grain foods to a reduced risk of
heart disease have been authorized through the notification procedure in section
403(r)(3)(C) of the Act. Of those authorized claims, the one closest to the
claim on your website 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.1" Although the claim on your website also concerns whole grains
and reduced risk of heart disease, it is different from the authorized claim in
significant ways. To meet the requirements of the authorized claim, the claim
must state that diets that are (1) rich in Whole grains and other plant foods,
and (2) low in saturated fat and cholesterol will help reduce the risk of heart
disease) Instead, the claim on your website only states that diets rich in whole
grains can reduce the risk of heart disease, with no mention of other plant
foods or of low saturated fat and cholesterol.

"Including whole grain as part of a healthy diet may ... [h]elp reduce the risk
of certain types of cancers. Regular consumption of whole grains as part of, a
low-fat diet reduces the risk for some cancers, especially cancers of the
stomach and colon."

This health claim misbrands your product because it has not been authorized
either by regulation [see section 343(r)(3)(A)-(B) of the Act [21 U.S.C. §
343(r)(3)(A)(B)]] or under authority of the health claim notification provision
of the Act [see section 343(r)(3)(C) of the Act [21 U.S.C. § 343(r)(3)(C)]].
Although FDA has issued a regulation authorizing a health claim associating
fiber-containing grain products with a reduced risk of cancer (21 CFR 101..76),
the claim on your website does not meet the requirements for the authorized
claim.For example, under section 101.76(c)(2) the claim must state that diets
high in fiber-containing grain products, fruits, and vegetables may reduce the
risk of some cancers. The claim on your website leaves out any reference to
fruits, vegetables, and fiber content. Therefore, your claim does not convey
that all these factors together help to reduce the risk of heart disease and
does not enable the public to understand the significance of the claim in the
context of the total daily diet [see section 343(r)(3)(B)(iii) of the Act [21
U.S.C. § 343(r)(3)(B)(iii)]].

In addition to the health claim authorized by regulation in 21 CFR 101.76, a
health claim linking the consumption of whole grain foods to a ...

read more »

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Relevant Pages

  • =?ISO-8859-1?Q?Re=3A_The_Beast_=28Aribert_Deckers=2C_AKA_Yappy_Rotten_Oys?= =?ISO-8859&#
    ... clinically proven to lower cholesterol. ... total and LDL cholesterol are a risk factor for coronary heart disease and can ... FDA has issued a regulation authorizing a health claim associating soluble fiber ... from whole grain oats with a reduced risk of coronary heart disease (21 CFR ...
    (misc.health.alternative)
  • Re: LINKS TO SKEPTICAL WEBSITES AND ORGANIZATIONS
    ... Toasted Whole Grain Oat Cereal is promoted for conditions that cause ... total and LDL cholesterol are a risk factor for coronary heart disease and can ... FDA has issued a regulation authorizing a health claim associating soluble fiber ... from whole grain oats with a reduced risk of coronary heart disease (21 CFR ...
    (misc.health.alternative)
  • WARNING LETTER
    ... Toasted Whole Grain Oat Cereal is promoted for conditions that cause ... total and LDL cholesterol are a risk factor for coronary heart disease and can ... FDA has issued a regulation authorizing a health claim associating soluble fiber ... from whole grain oats with a reduced risk of coronary heart disease (21 CFR ...
    (misc.health.alternative)
  • Re: Danger of trans fats is a myth?
    ... Willett about his condemnation of saturated fatty acids, ... > repeats his claim that trans fatty acids pose no risk for heart disease. ... > cholesterol and heart disease and refers to my "acknowledgment that the ...
    (sci.med.nutrition)
  • Re: Lp (a)
    ... or ask your doc, given your low calc risk, why take ... If you're a woman like me who worries about your blood cholesterol ... drugs are useful for women who are otherwise healthy. ... statins in men who didn't have prior heart disease. ...
    (sci.med.cardiology)