Businessman Arrested For Introducing Misbranded Drugs Into Interstate Commerce, Conspiracy, Wire And Mail Fraud

SAN JUAN, P.R. – Yesterday, a Federal grand jury returned an indictment against Jorge L. Pagán Kortright and his companies AWD Group Inc. doing business as El Torito USA, Inc., Allied Worldwide Distributors Inc., and All Wheel Drive Corp., for introduction of misbranded drugs into interstate commerce, conspiracy to commit wire fraud, wire fraud, and mail fraud, announced Rosa Emilia Rodríguez-Vélez, United States Attorney for the District of Puerto Rico. The investigation was led by the Food and Drug Administration, Office of Criminal Investigations (FDA-OCI), with the collaboration of the Puerto Rico Police Department, Guayama Municipal Police, and the Puerto Rico Treasury Department (Departamento de Hacienda).

The indictment alleges that the defendants, aiding and abetting each other, with the intent to defraud or mislead, introduced and delivered for introduction into interstate commerce drugs, namely, “El Torito Plus 1000 mg,” ‘El Torito Xtreme 500 mg,” and “El Torito Black Bull Power 500 mg” that were misbranded; the labeling of each drug was false and misleading. The drugs were sold on El Torito’s website, Amazon.com, eBay.com, and at gas stations throughout Puerto Rico.

“El Torito Plus 1000 mg,” “El Torito Xtreme 500 mg,” and “El Torito Black Bull Power 500 mg,” were capsules and pills sold over the counter and on the Internet that were labeled and marketed as “100% natural” dietary supplements and performance enhancers. The capsules and pills were marketed as “natural supplements for men and women” to “help” “achieve a pleasant and lasting sexual experience with all natural ingredients.” In fact, El Torito’s products contained sildenafil and tadalafil (the active ingredients in Viagra™ and Cialis™ respectively), and their synthetic analogs, including desmethyl-carbodenafil and dithiodesmethyl-carbodenafil.  Sildenafil and tadalafil are the active ingredients of branded drugs approved by the FDA and are also “prescription drugs” that, because of their toxicity and other potential harmful effects, were not safe for use except under the supervision of a practitioner licensed by law to administer such drugs.  These undeclared ingredients may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels for individuals with diabetes, high blood pressure, high cholesterol, or heart disease.

It was the object of the conspiracy for defendants and their coconspirators to unlawfully enrich themselves by obtaining money and property from individuals under the false and fraudulent pretenses and representation that individuals were purchasing “100% natural” dietary supplements and performance enhancers when, in fact, defendants were selling misbranded prescription drugs.

During the course of the conspiracy, e-mail communications were sent by defendants to their manufacturers, distributors, and others in furtherance of the scheme to defraud and payments were received using PayPal. For example, one of the emails sent by an El Torito distributor to lttcards@gmail.com under the name “Jorge Pagan” stated that: “you need to change the pictures of Torito chinese box from the website because the sheriff will probably look at the site for info and i told them that Torito is made in usa and i showed them the box without the chinese letters.”

Another email communication sent from lttcards@gmail.com under the name “Jorge Pagan” to a manufacturing contact stated that he was “only worried about my investment and the loss of money if authorities find controlled ingredients. The authority will only get involve when the big pharmasuricals [sic] companies pressure them because they lose sales with these products.” “If Mr. Wangs product get problems, all he has to do is send me a new brand name box and just change the style of the packaging the capsule in the blister pack and we can do this for ten years. So the authorities will be fooled all the time.”

As part of the scheme to commit the mail fraud, the defendants knowingly placed in an authorized depository for mail, to be sent and delivered by the United States Postal Service, numerous El Torito products.

“The authorities were not fooled by these criminals who are now in federal custody,” said United States Attorney, Rosa Emilia Rodríguez-Vélez. “The law requires that drugs be produced and branded under the most rigorous of quality standards. When individuals and companies fail to exercise the vigilance that the law demands, they will held be accountable. Today’s arrest shows that we will not tolerate criminals who engage in fraudulent schemes in order to enrich themselves without considering how their actions may affect the health and well-being of others.”

“Distributing prescription drugs disguised as all-natural dietary supplements puts the health and safety of the American public at risk,” said Acting Special Agent in Charge Robert J. West, FDA Office of Criminal Investigations’ Miami Field Office. “We will continue to focus our resources on removing illegal products from the marketplace, as well as prosecuting those who attempt to evade FDA regulations.”

FDA-OCI was the lead agency which conducted the investigation, with the collaboration of PRPD, Hacienda and the Guayama Municipal Police. The case is being prosecuted by Assistant U.S. Attorney Luke Cass. Attorney Shannon M. Singleton from the FDA’s Office of Chief Counsel provided valuable assistance to this criminal investigation.

If found guilty, the defendant could face a possible sentence of up to 30 years in prison for the mail and wire fraud counts. Indictments contain only charges and are not evidence of guilt. Defendants are presumed innocent unless and until proven guilty by a unanimous jury.

If you have used El Torito products in the past and have questions you may call 1-888-INFO-FDA or contact the FDA online at www.fda.gov.