Regulatory Focus™ > News Articles > US Regulators Debar Man for Marketing Unapproved Products

US Regulators Debar Man for Marketing Unapproved Products

Posted 29 June 2012 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has issued a debarment order against a man convicted of introducing two pharmaceutical products into interstate commerce in violation of federal law after he claimed his unapproved products could treat a range of ailments including cystic fibrosis, SARS and tuberculosis.

In its 29 June 2012 Federal Register posting, FDA recounted what it called the "factual basis" for its debarment order, starting with a warning letter sent to Sami Arshak Yanikian in 2005. In the letter, FDA cited Yanikian for allegedly marketing "Super Nasal Drops" and "Sam's No Tinnitus Formulation" without having received proper approval from FDA in the form of New Drug Application approval.

Despite the innocuous sounding names of the two products, Yanikian marketed them as treatments and possible cures for everything from atrial fibrillation to influenza, SARS, tuberculosis and cystic fibrosis. At the time of the 2005 warning letter, FDA advised Yanikian to "immediately correct these violations."

"In response, on April 11, 2005, Mr. Yanikian wrote a reply letter to FDA in which he stated that the products were mailed for sale outside the United States to hospitals that deal with natural health products," explained FDA. "He further noted that his products were not intended for sale as over-the-counter or for single individuals in the United States until they were approved by FDA."

FDA later conducted two undercover sting operations in 2005 and 2006 in which Yanikian allegedly sold his products to the undercover FDA agent. The operations would later form the basis of a court case and subsequent conviction against Yanikian. After issuing a notice of intent to debar to Yanikian and receiving no response, FDA said it is debarring Yanikian for a period of ten years, during which time no company may utilize his services on any New Drug Application.

"[The] type of conduct that served as the basis for Mr. Yanikian's convictions undermine the process for the regulation of drugs," FDA wrote.


Read more:

2005 Warning Letter Against Yanikian

2011 Notice of Conviction of Yanikian

2012 Debarment Order Against Yanikian


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