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Senior Alerts
Avian Flu Treatments Found Fraudulent by FDA
Dec. 14, 2004 - The U.S. Food and Drug
Administration (FDA) has issued warning letters to nine companies
marketing bogus flu products behind claims that their products could be
effective against preventing the avian flu or other forms of influenza.
FDA is not aware of any scientific evidence that demonstrates the safety
or effectiveness of these products for treating or preventing avian flu
and the agency is concerned that the use of these products could harm
consumers or interfere with conventional treatments.
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Nov. 29, 2005 - The U.S. Food and Drug
Administration (FDA) yesterday announced that MBI Distributing, Inc. (MBI)
has agreed to cease manufacturing and distributing drugs until it
corrects manufacturing deficiencies. Senior citizens should check to see
if they have any of these eye drops - Oxydrops, Bright Eyes, Bright Eyes
II, Clarity Vision for Life, Visitein or Can-C. MBI also makes OTC pain
relieving drugs, including Biogesic, Bio-Ice and Bio-Heat.
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FDA Issues Warnings to Marketers of Unapproved
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Items promoted to seniors for treatment or prevention
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Nov. 16, 2005 - The Food and Drug Administration
has announced action against a number of firms marketing unapproved
"Alternative Hormone Therapies," because the products these firms are
selling are unapproved new drugs that have not been found safe and
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diseases or conditions. The advertising targets older women.
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Doctor Charged for Fake Flu Shots Given
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Oct. 31,205 A doctor is accused of giving flu
shots of purified water, rather than flu vaccine, to at least 14 senior
citizens that lived in a nursing home near La Porte, Texas, and to more
than 1,000 employees of Exxon Mobile near Baytown. His motive, says the
government, was to defraud Medicare. The news created a scary vision for
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More Senior Alerts -
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"There are initiatives in place to deter
counterfeiters and those who sell fraudulent or phony products to
prevent or treat avian flu," said Andrew von Eschenbach, MD, Acting FDA
Commissioner.
"The use of unproven flu cures and treatments
increases the risk of catching and spreading the flu rather than
lessening it because people assume they are protected and safe and they
aren't. I consider it a public health hazard when people are lured into
using bogus treatments based on deceptive or fraudulent medical claims."
FDA issued Warning Letters to nine firms marketing
products making unproven claims that they treat or prevent avian flu or
other forms of influenza. Eight of the products purported to be dietary
supplements. Examples of the unproven claims cited in the Warning
Letters include: "prevents avian flu," "a natural virus shield," "kills
the virus," and "treats the avian flu." These alternative therapies are
promoted as "natural" or "safer" treatments that can be used in place of
an approved treatment or preventative medical product.
In the Warning Letters, FDA advises the firms that
it considers their products to be drugs because they claim to treat or
prevent disease. The Warning Letters further state that FDA considers
these products to be "new drugs" that require FDA approval before
marketing. The letters also note that the claims regarding avian flu are
false and misleading because there is no scientific basis for concluding
that the products are effective to treat or prevent avian flu. The
companies have 15 days to respond to FDA.
Consumers who believe that they have seen a
fraudulent product can report it to the FDA at
http://www.fda.gov/oc/buyonline/buyonlineform.htm.
For information on helping prevent flu, see the
Centers for Disease Control and Prevention
http://www.cdc.gov/flu/protect/preventing.htm.
FDA
Warning Letters: (Product in parenthesis)
Sacred Mountain Management Inc. (Nature's Biotics)
http://www.fda.gov/foi/warning_letters/g5630d.pdf
http://www.fda.gov/foi/warning_letters/g5630d.htm
BODeSTORE.com (Lingoji)
http://www.fda.gov/foi/warning_letters/g5632d.pdf
http://www.fda.gov/foi/warning_letters/g5632d.htm
Melvin Williams (Natural Cellular Defense)
http://www.fda.gov/foi/warning_letters/g5634d.pdf
http://www.fda.gov/foi/warning_letters/g5634d.htm
Iceland Health Inc. (Immunity Plus)
http://www.fda.gov/foi/warning_letters/g5636d.pdf
http://www.fda.gov/foi/warning_letters/g5636d.htm
PolyCil Health Inc. (Immunocil)
http://www.fda.gov/foi/warning_letters/g5629d.pdf
http://www.fda.gov/foi/warning_letters/g5629d.htm
PRB Pharmaceuticals Inc. (Vira 38)
http://www.fda.gov/foi/warning_letters/g5628d.pdf
http://www.fda.gov/foi/warning_letters/g5628d.htm
Chozyn, LLC (Lingoji)
http://www.fda.gov/foi/warning_letters/g5631d.pdf
http://www.fda.gov/foi/warning_letters/g5631d.htm
Vitacost.com (NSI GliSODinฎ, NSI Superior Ester-C
with Quercetin and Bioflavonoids; NSI Vitamin C; NSI Green Tea Extract,
NSI Activated Quercetin Complex, NSI Probiotic with Acidophilus,
Rhamnosus, Thermophilus and Bulgaricus, NSI AHCC+ Immune Power, and NSI
L-Optizinc)
http://www.fda.gov/foi/warning_letters/g5633d.pdf
http://www.fda.gov/foi/warning_letters/g5633d.htm
Healthworks 2000 (ZymePro Plus w/Serrapeplase)
http://www.fda.gov/foi/warning_letters/g5635d.pdf
http://www.fda.gov/foi/warning_letters/g5635d.htm
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