FDA Cracks Down on Fake Cures
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, Richard 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 Gary 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:
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.
About The Author:
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
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