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From: TSS (216-119-144-66.ipset24.wt.net)
Subject: FDA WARNING LETTER FOR MAD COW CJD MIRACLE CURE THAT IS BSeee
Date: January 11, 2005 at 9:45 am PST

-------- Original Message --------
Subject: FDA WARNING LETTER FOR MAD COW CJD MIRACLE CURE THAT IS BSeee
Date: Tue, 11 Jan 2005 09:13:47 -0600
From: "Terry S. Singeltary Sr."
Reply-To: Bovine Spongiform Encephalopathy
To: BSE-L@LISTSERV.KALIV.UNI-KARLSRUHE.DE


##################### Bovine Spongiform Encephalopathy #####################

Department of Health and Human Services

Public Health Service
Food and Drug Administration

Detroit District
300 River Place
Suite 5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139


CERTIFTED MAIL
RETURN RECEIPT REQUESTED

December 21, 2004

WARNING LETTER
2005-DT- 07

Mr. Douglas C. Klimesh
President
N64 Neutraceutica
2922 Roundtree Blvd.
Ypsilanti, MI 48197

Dear Mr. Klimesh:

The U.S. Food and Drug Administration (FDA or the agency) conducted an
inspection of your firm, N64 Neutraceutica on September 22 and October
4, 7, and 28, 2004. During this inspection, you provided FDAs
investigators with labeling for your firms products, which the agency
has reviewed. FDA has also reviewed your web site at the Internet
address http://www.grazoph.com. Based on our review, we have determined
that your products Grazoph Temuna, Grazoph Tipremunak,  WOWPOA,
Deparalysis Neutraceutical,  Curandaros general herbal formulas,
and Personal Spectral Formulas are promoted for conditions that cause
them to be drugs under section 201(g)(k) of the Federal Food, Drug, and
Cosmetic Act (the Act) [21 USC 321(g)(1)]. The therapeutic claims in
your products labeling, including your web site, establish that these
products are drugs because they are intended for use in the cure,
mitigation, treatment, or prevention of disease.

Products and therapeutic claims include, but are not limited, to the
following:

Grazoph Temuna:

About enough to clear one full blown Alzheimers case. What Grazoph
Temuna is good for:

* Alzheimers effects
* Preventative: Helps prevent many forms of dementias from taking
hold. This is relief for the certain Alzheimers Dementia
diseases.. . . [M]ay be very helpful for preventing Picks Disease
and Creutzfeldt-Jakob Disease, and to a lesser extent
Multi-Infarct Dementia. Is thought to work also to relieve
azotemia, bactremia [sic], cellulitis, sinsusitis [sic]....

[T]reats that which is often called detached retina of eye
[S]aves victims of Mad Cow Disease (Creutzfeld-Jakob Disease) if
applied in time.

Grazoph Tipremunak:

[R]everses condition of Parkinsons disease.. . .
Parkinsons Reverser-For Parkinsons Disease Only
Result of taking Grazoph Tipremunak: The general result of Parkinsons
sufferers taking one packet of Parkinsons Reverser is that it clears
tremors completely for several days, and reduces the depth of the
disease typically by 5% overall. Additional treatment will continue to
reduce the disease. Grazoph tipremunak may need to by used 12 times
before Parkinsons is entirely eliminated,

WOWPOA:

Guaranteed to eliminate migraines for six years.
I had severe migraines for 30 years, than I met Jauncey. He gave me
enough WOWPOA to neutralize my entire migraine. (Testimonial)
Cerebrospinal Poison Antidote (Product label)
[T]he migraine dissolver (Product label)

Deparalysis Neutraceutical:

[H]elps serious self-healers overcome Spinal Paralysis.

Curandaros general herbal formulas:

Get rid of Cancer using the Curandaros general herbal formulas.
Guaranteed to eliminate cancer in one year and free from cancer for at
least 5 years!

Personal Spectral Formulas:

[M]ultiple formulas totaling more than a hundred herbs and possibility
of cancer and other diseases may be eliminated in the first days of the
use of these personal spectral formullas.
[S]pectral-formula-for-one-only also arrests pre-cancers, cancers which
will not happen because of herbal medicines . . . .
Our Curanderos have developed formulas for Lung Cancer, Nose & Ovarian
Cancers, Spinal Paralysis, Tuberculosis, Asthma, Diabetes, Gout. Our
curandero has abilities and has accumulated [a] vast herb assortment
useful for helping many type[s] of neural/mental conditions such as
Grand Mal Seizures, Schizophrenia, Dementias, . . . Traumatic Injury, .
. . Diabetes, Sarcoma, Schizophrenia, . . . Parkinsons, Broken neck,
Alcolholism [sic], . . . Tuberculosis, Lupus, Asthma, Prostate Cancer .
. . . We have a formula that permenently [sic] stops pain from Multiple
Sclerosis . . . .

Brain & Body Cleanser Power Pack:

Helps prevent most kinds of Alzheimers diseases . , ., (Product label)

Furthermore, your products are not generally recognized as safe and
effective for the above referenced conditions and therefore, the
products are also new drugs under section 201(p) of the Act [21 USC
321 (p)]. New drugs may not be legally marketed in the U.S. without
prior approval from FDA as described in section 505(a) of the Act [21
USC 355(a)]. FDA approves a new drug on the basis of scientific data
submitted by a drug sponsor to demonstrate that the drug is safe and
effective. These drugs are also misbranded within the meaning of section
502(f)(1) of the Act [21 USC 352(f)(1)], in that the labeling for these
drugs fails to bear adequate directions for use.

The above violations are not meant to be an all-inclusive list of
deficiencies for your products or their labeling. It is your
responsibility to ensure that products marketed by your firm comply with
the Act and its implementing regulations.

The Act authorizes the seizure of illegal products and injunctions
against manufacturers and distributors of those products. You should
take prompt action to correct these deviations and prevent their future
recurrence. Failure to do so may result in enforcement action without
further notice.

Please advise this offer, in writing and within fifteen (15) working
days of the receipt of this letter, as to the specific steps you have
taken to correct the violations noted above and to ensure that similar
violations do not occur. If corrective actions cannot be completed
within fifteen working days, state the reason for the delay and the time
within which the corrections will be completed.

Your reply should be sent to the attention of Mrs. Judith A. Putz,
Compliance Officer, 300 River Place, Suite 5900, Detroit, MI 48207.

Sincerely yours,

/s/

Joann M. Givens
District Director

cc:
Mr. Daniel Lexington
N64 Neutraceutica
2922 Roundtree Blvd.
Ypsilanti, MI 48197

http://www.fda.gov/foi/warning_letters/g5138d.htm

Brain contaminant diseases, as well as other body contaminants, can be
washed clear with natural enzyme bath enabled by Grazoph. On the list of
diseases which Grazoph Temuna should be used to alleviate are: Mad Cow
disease (yes Grazoph works in cows), Creutzfeldt-Jakob, Azotemia,
Bactremia, Pick's disease, and many other diseases that are being caused
by poisonous dusts.

http://www.grazoph.com/

PREVENTATIVE: Helps prevent many forms of dementias from taking hold.
This is relief for the certain Alzheimer's Dementia diseases. We
theorize that Grazoph Temuna antidemential dissimulator may be very
helpful for preventing Pick's Disease and Creutzfeldt-Jakob Disease, and
to a lesser extent Multi-Infarct Dementia. Is thought to work also to
relieve azotemia, bactremia, cellulitis, sinsusitis and post-ictal
state. Creuzfeldt-Jacob is evidently the fast production of a lot of
contaminents that overwhelm the brain and nervous system; we observe
that Grazoph enzyme productions hang up the production of the
contaminents and washes clean the residues.

http://www.grazoph.com/temuna.shtml

Docket Management Docket: 96N-0417 - Current Good Manufacturing Practice
in Manufacturing, Packing, or Holding Dietary Ingredients a
Comment Number: EC -2
Accepted - Volume 7

http://www.fda.gov/ohrms/dockets/dailys/03/Mar03/031403/96N-0417-EC-2.htm


TSS

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