Inspections, Compliance, Enforcement, and Criminal Investigations
March 23, 2011: L.A. Man Convicted of Illegally Marketing Unapproved Drugs with Claims that Various Ailments Would be Cured
Sami Arshak Yanikian, 62, of the County Club Park district of Los Angeles, was found guilty this afternoon of two counts of introducing unapproved new drugs into interstate commerce.
The evidence presented during a two-day trial in federal court showed that Yanikian used a website to market products that included “Sam’s Inhaler Spray For Viral Respiratory Infections” and “Sam’s Universal Oral Spray.” The website claimed that one of the products could reverse ailments such as pneumonia, chronic bronchitis, COPD, cystic fibrosis, tuberculosis and respiratory viral conditions. Yanikian also claimed the product would help a person to quit smoking.
In 2005, the Food and Drug Administration sent a warning letter to Yanikian, informing him that he was marketing a “drug” and that he was making specific claims about his products, even though there was no evidence that they were generally recognized as safe and effective for their labeled uses. Yanikian responded to the FDA, saying that he was selling the products abroad. However, as the jury heard during the trial, Yanikian actually sold his products to an undercover agent in Tempe, Arizona.
Yanikian was found guilty of two misdemeanor counts, each of which carries a statutory maximum penalty of one year in federal prison.
Yanikian is scheduled to be sentenced by United States Magistrate Judge Victor B. Kenton on June 6.
The case against Yanikian was investigated by the FDA’s Office of Criminal Investigations.