An executive of two Farmingdale dietary supplement companies was arrested yesterday by federal agents on charges of manufacturing and selling the pill Vigor-25 as a non-prescription "herbal supplement developed to boost your sexual pleasure and sexual performance."
Vigor-25 is suprisingly effective and widely popular as an erectile dysfunction drug, which is sold on the Internet and in small groceries and some health food stores, officials said, estimating that as much as $24 million has been made in the last several years selling at least 4 million pills.
There was only one problem. The active ingredient in Vigor-25 was not the rare combination of natural ingredients listed on the label, such as rhodiola rhizome, chinese yam, cnidium fruit or cassia, officials said.
Rather, the active and effective component, they said, was the generic version of the chemical in Viagra -- sildenafil citrate -- or similar chemicals which had been illegally smuggled in from China.
And when the executive, Michael Peng, 55, of Flushing, was warned about using Viagra-like compounds in his pills, he switched to using chemicals similar to those in another erectile dysfunction drug, Levitra, officials said.
Peng, 55, of Flushing, was arraigned in U.S. District Court in Central Islip, on charges of introducing into "interstate commerce adulterated or misbranded" drugs.
Peng is the president of the company that markets Vigor-25, the V. Vigor Corp., and general manger of the company that manufactures the pill, Greenvalley. They are both located at 165A Marine St., Farmingdale.
Peng was not required to enter a plea, pending future hearings. His attorney, Dennis Lemke, declined to comment after the arraignment, as did Assistant U.S. Attorney Nicole Boeckmann.
In court documents, FDA criminal investigator Thomas Nasiatka said the agency was concerned that people who take common drugs containing nitrates to control diabetes, high blood pressure and heart disease might be seriously harmed if they took Vigor-25 without being aware that it containes generic versions of Viagra and related chemicals.
"A consumer who uses Vigor-25 would not know that these undeclared ingredients may interact with prescription drugs that contain nitrates, such as nitroglycerin, and would lower blood pressure to dangerous levels," Nasiatka said in the court papers. There have been no reports so far of anyone harmed by taking Vigor-25, officials said.
According to court papers, FDA testing also revealed that in addition to the generic form of Viagra, some batches of Vigor-25 later contained a chemical similar to vardenafil, the generic form of Levitra.
In November, 2004, Peng and an associate at the companies identified as Jane Doe had been told by FDA investigators that Vigor-25 had been found to contain the generic ingredient in Viagra, and they agreed to stop selling it in the future as well as the 350,000 capsules they had in stock, the court papers said.
But he continued to keep selling the pills laced with analogs of vardenafil, the documents said.
The analogs, such as piperidenafil, are copycat chemicals that are legally considered equivalent to the ones they are mimicking because they are structurally almost identical and act in the body in the same manner, according to officials.
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