FDA Cracks Down on Fake Cures

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Article Title:

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FDA Cracks Down on Fake Cures

Article Description:

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In an effort to crack down on charlatans who prey on the sick,

the U.S. Food and Drug Administration (FDA) recently issued

warning letters to 23 U.S. companies and two foreign individuals

marketing a wide range of products that fraudulently claim to

prevent and cure cancer.

Additional Article Information:

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406 Words; formatted to 65 Characters per Line

Distribution Date and Time: 2008-08-14 11:36:00

Written By: Norm Howe

Copyright: 2008

Contact Email: mailto:info@...

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FDA Cracks Down on Fake Cures

Copyright © 2008 Norm Howe

Validation and Compliance Institute

http://www.vcillc.com

Licensed physicians prescribe drugs that undergo clinical testing

to determine if they are safe and effective for their intended

uses. These drugs have been clinically tested or reviewed by FDA

for safety and effectiveness.

Of course, where there are rules and regulations, there will be

those who try to take shortcuts.

In an effort to crack down on charlatans who prey on the sick,

the U.S. Food and Drug Administration (FDA) recently issued

warning letters to 23 U.S. companies and two foreign individuals

marketing a wide range of products that fraudulently claim to

prevent and cure cancer.

Those companies and/or individuals include Vitasalus, Inc.

(Nu-Gen Nutrition), USA Golden Vision, McPhail (Be

Healed), Ageless Cures, Plantcures.com, Precision Herbs, Burt

Hampton (The Original Cream Company), Coral Calcium, JHS

Naturals, Vitapurity AKA: Vitapurity Corp, Millenium Health,

Herbs for Cancer, Triherba Marketing, Herbal Remission, Nutrition

2000, Superb Herbs AKA: FemHealth, Wallcann-Cura-Care.com, Road

to Healing, Herbtime, New Sun Inc., The Institute for Healthy

Aging, Gemtronics, H and L Worldwide Inc. (Vitasprings),

Generation, and Best on Earth Products.

Because these products claim to cure, treat, mitigate or prevent

disease, and these products have not been shown to be safe and

effective for their labeled conditions of use, they are

unapproved new drugs marketed in violation of the Federal Food,

Drug, and Cosmetic Act.

According to Coody, R.Ph., the National Health Fraud

Coordinator and a Consumer Safety Officer with the FDA Office of

Regulatory Affairs, red flag claims consumers should be on the

lookout for include:

* " Treats all forms of cancer " ; * " Skin cancers disappear " ;

* " Shrinks malignant tumors " ; * " Non-toxic " ; * " Doesn't

make you sick " ; * " Avoid painful surgery, radiotherapy,

chemotherapy, or other conventional treatments " ; and/or *

" Treat Non Melanoma Skin Cancers easily and safely " .

The FDA urges consumers to avoid products that bear claims of:

being a quick and effective cure-all or a diagnostic tool for a

wide variety of ailments; treating or curing serious or incurable

diseases; being a " scientific breakthrough " or a " miraculous

cure " ; containing a " secret ingredient " or " ancient remedy " ;

possessing a " hunger stimulation point " or " thermogenesis "

(for a weight loss product); safety because it is " natural " ;

limited availability and advance payment requirements; no-risk,

money-back guarantees; or being an " easy " fix for problems like

excess weight, hair loss or impotency.

Parties that fail to properly resolve violations cited in the

Warning Letters issued will be subject to enforcement action up

to and including seizure of illegal products, injunction and

possible criminal prosecution.

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Norm Howe, Senior Partner at Validation and Compliance Institute,

consultants for the pharmaceutical and medical device industries.

He got his BS at UC, Berkeley, and a Ph.D. in chemistry at UCLA.

He has held many management positions in FDA regulated industries,

most at BASF. http://www.vcillc.com