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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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Eye Drop Maker Agrees to FDA Order to Stop Manufacturing Products

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. Read more...

FDA Issues Warnings to Marketers of Unapproved 'Alternative Hormone Therapies'

Items promoted to seniors for treatment or prevention of cancer, heart disease, and osteoporosis

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 effective to treat or prevent certain serious or life-threatening diseases or conditions. The advertising targets older women. Read more...

Doctor Charged for Fake Flu Shots Given to Senior Citizens

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 many seniors this Halloween day. Read more...

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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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