via email
Re: FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs
Dear Ms. Chappelle:
The FDA can not simply have it both ways. The 1997 government patent on tetrasil speaks for itself. The FDA is merely standing in the way of restoring the health of millions and millions of people, mostly of color. To date, the FDA has never addressed the U.S. Special (Cancer) Virus program (1962 – 1978).
To date, the FDA has never addressed the visna sheep sequences in the blood of people with HIV/AIDS. See, PROC NAS Vol. 83, pp. 4007 – 11, June 1986. See also, PROC NAS Vol. 92, pp. 3283 – 3287, April 11, 1995.
The current 2008 “Understanding HIV and AIDS” poster is identical to the virus created in the Special Virus program. See, Nature New Biology, Vol. 232, pp. 140 – 2, 1971.
The U.S. patent below deserves “immediate scrutiny” from the FDA, not tomorrow, today.
Boyd Ed Graves, J.D.
www.boydgraves.com
619-849-9364
------
Showing posts with label Rita Chapelle. Show all posts
Showing posts with label Rita Chapelle. Show all posts
Tuesday, March 11, 2008
FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs
FDA News
FOR IMMEDIATE RELEASE
March 6, 2008
Media Inquiries:
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs
The U.S. Food and Drug Administration today issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs).
Some of these products, directed at U.S. consumers, falsely claim to have "FDA Approval" and some claim to be "more effective" than conventional medicine. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.
"The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. "STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs."
The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The FDA considers these U.S. and imported products to be unapproved new drugs being marketed in violation of the Federal Food, Drug and Cosmetic Act. They are also misbranded under the law because they lack proper directions for use by consumers. In addition, some of the products are misbranded because they make false and misleading claims.
Examples of claims that these products make include "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications," "Greatest STD Protection Without Condoms," (SlicPlus) and "The active ingredient in our product is FDA certified to destroy 99.9992 percent of all pathogenic organisms [ie] Chlamydia" (OXi-MED).
The Warning Letters inform the companies that failure to properly resolve violations of the law may cause them to face further enforcement action that can include seizure of illegal products, injunction, and possible criminal prosecution.
Issuing these Warning Letters is part of the FDA’s ongoing campaign against fraudulent products marketed on the Internet for serious and life-threatening diseases. The agency also works to educate consumers about the risks and dangers that exist from buying unsafe products.
Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.
To view the letters,
http://www.fda.gov/foi/warning_letters/s6680c.htm - Aviralex Int.
http://www.fda.gov/foi/warning_letters/s6681c.htm - Aidance Skincare
http://www.fda.gov/foi/warning_letters/s6682c.htm - Health-science-report
http://www.fda.gov/foi/warning_letters/s6683c.htm - NeumaLife
http://www.fda.gov/foi/warning_letters/s6684c.htm - IMULUX, LLC
http://www.fda.gov/foi/warning_letters/s6685c.htm - Saferex Laboratories
http://www.fda.gov/foi/warning_letters/s6686c.htm - McKinnon, Blair
#
FOR IMMEDIATE RELEASE
March 6, 2008
Media Inquiries:
Rita Chappelle, 301-827-6242
Consumer Inquiries:
888-INFO-FDA
FDA Warns Companies Importing and Marketing Drugs Over the Internet that Fraudulently Claim to Prevent and Treat STDs
The U.S. Food and Drug Administration today issued Warning Letters to six U.S. companies and one foreign individual for marketing unapproved and misbranded drugs over the Internet to U.S. consumers for the prevention and treatment of sexually transmitted diseases (STDs).
Some of these products, directed at U.S. consumers, falsely claim to have "FDA Approval" and some claim to be "more effective" than conventional medicine. The products are sold as Tetrasil, Genisil, Aviralex, OXi-MED, Imulux, Beta-mannan, Micronutrient, Qina, and SlicPlus. Consumers who are currently using these products should stop their use immediately and consult their health care professional if they have experienced any adverse effects that they suspect are related to the use of any of these products.
"The products pose a serious health threat to unsuspecting consumers who don’t know that these products are not FDA approved and have not been proven safe or effective," said Janet Woodcock, M.D., deputy commissioner for scientific and medical programs, chief medical officer, and acting director of the FDA’s Center for Drug Evaluation and Research. "STDs are very serious diseases and these products give consumers a false sense of security that they are protected from STDs."
The products claim to prevent or treat a variety of STDs, including Herpes, Chlamydia, Human Papilloma Virus, cervical dysplasia, and HIV/AIDS. The FDA considers these U.S. and imported products to be unapproved new drugs being marketed in violation of the Federal Food, Drug and Cosmetic Act. They are also misbranded under the law because they lack proper directions for use by consumers. In addition, some of the products are misbranded because they make false and misleading claims.
Examples of claims that these products make include "Treatment Kills all Herpes Viruses WITHOUT having to use conventional drugs or medications," "Greatest STD Protection Without Condoms," (SlicPlus) and "The active ingredient in our product is FDA certified to destroy 99.9992 percent of all pathogenic organisms [ie] Chlamydia" (OXi-MED).
The Warning Letters inform the companies that failure to properly resolve violations of the law may cause them to face further enforcement action that can include seizure of illegal products, injunction, and possible criminal prosecution.
Issuing these Warning Letters is part of the FDA’s ongoing campaign against fraudulent products marketed on the Internet for serious and life-threatening diseases. The agency also works to educate consumers about the risks and dangers that exist from buying unsafe products.
Consumers and health care professionals should notify the FDA of any complaints or problems associated with these products. These reports may be made to MedWatch, the FDA’s voluntary reporting program, by calling 800-FDA-1088, or electronically at www.fda.gov/medwatch/report.htm.
To view the letters,
http://www.fda.gov/foi/warning_letters/s6680c.htm - Aviralex Int.
http://www.fda.gov/foi/warning_letters/s6681c.htm - Aidance Skincare
http://www.fda.gov/foi/warning_letters/s6682c.htm - Health-science-report
http://www.fda.gov/foi/warning_letters/s6683c.htm - NeumaLife
http://www.fda.gov/foi/warning_letters/s6684c.htm - IMULUX, LLC
http://www.fda.gov/foi/warning_letters/s6685c.htm - Saferex Laboratories
http://www.fda.gov/foi/warning_letters/s6686c.htm - McKinnon, Blair
#
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