Kessler’s investigation disclosed that a few unscrupulous businessman are trafficking these pharmaceutical creams in the United States as if they were simple over-the-counter cosmetic products," said Michael G. Kessler, President & CEO of Kessler International. Kessler International has notified the US FDA Office of Criminal Investigation and US Customs as well as state agencies in New York, New Jersey, Texas, Florida and Illinois. "They are violating numerous state and federal laws”, he said and “ the U S Food and Drug Administration, US Customs and as well state and local agencies are failing to take any action.”

In August 1999, Christine Whelan wrote in The Wall Street Journal the dangers associated with the use of these pharmaceuticals. The FDA at that time would not confirm any criminal investigation and U S Customs disclosed there were no FDA alerts issued about the creams. To date nothing has been done to curb the trafficking of these products without a prescription to the public. 

Undercover investigators that questioned buyers (most of which are dark skin women) of these products obtained information that the products were being used so that “dark spots on their faces and bodies faded” and that after use they “appeared to have a new glow “ emanating from their skin. 

Women, who apply these creams to their bodies as if they were a daily moisturizer, overlook the serious side effects related to the prescribed use of this medicine. Prominent dermatologists that have been contacted indicated that these prescription creams could cause “extreme adverse reactions.” Many of the counterfeit pharmaceuticals being sold contain undisclosed amounts of industrial bleach, which is primarily used as a film developer. In pharmaceutical creams it works to reduce the production of melanin, the skin protector and pigment that gives individuals their dark skin coloring.  

U.S. law requires the steroids in these creams be administered with a prescription under the care of a licensed physician because of serious side effects that come along with usage. For example, if a steroid cream was used without proper instruction, the user could see stretch marks, thinning and tearing skin, rashes, welts, and serious burns. If the product was used on a regular basis for a prolonged period of time, more serious side effects including headaches, vomiting, poor breathing, convulsions, liver and kidney damage, and organ failure could occur.

Kessler International’s investigation into the diversion and sale of these black market pharmaceuticals is a continuing investigation. 

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