Inspections, Compliance, Enforcement, and Criminal Investigations
August 12, 2011: Vista California Company Sentenced for Sale of Unapproved Medical Devices
United States Attorney Laura E. Duffy announced that CNGI, Inc. was sentenced today in federal court in San Diego by the Honorable Janis L. Sammartino to pay a $100,000 fine following their guilty pleas to the sale of unapproved medical devices. The Court also ordered CNGI, Inc. to forfeit $30,000 as substitute assets for devices which lay beyond the reach of the Court. United States Magistrate Judge Louisa S. Porter also sentenced Randy Frager, the owner and operator of CNGI, Inc., to a one-year term of probation.
According to court documents, Randy Frager and CNGI, Inc. sold a product called “The Detox Box,” a “Rife-style” device consisting of a micro-current frequency generator with a digital readout, two stainless steel cylinders, two personal application plates with connectors and lead wires connecting the device to the cylinders and the plates. Users were provided with an operating manual that set forth hundreds of digital settings for the device, directed to specific conditions from Alzheimer’s, cancer and leukemia to Zycomycosis. Users were advised to connect the cylinders or plates to the machine and touch them to the body for a recommended run time to treat each condition.
At the sentencing hearing, Judge Sammartino found that from July of 2007 through February of 2011, the defendants purchased over 1,200 units, which they mailed to customers throughout the United States. The Court further found that the defendants sold the devices to distributors for approximately $1,400 and to retail customers for $2,000 and had sales of approximately $2 million. The devices were adulterated in that they were marketed without proper approval from the Food and Drug Administration (FDA).
DEFENDANTS Criminal Case No. 11-CR-1268JLS
CNGI, Inc. Date of Incorporation: 9-20-00 Vista, California
Randy Frager Age:41 Oceanside, California
SUMMARY OF CHARGES
Count 1 (CNGI, Inc.)
Introduction of an Adulterated Device into Interstate Commerce, in violation of Title 21, United States Code, Sections 331(a), 333(a)(2) and 351(e) and (f), a felony
Count 2 (Randy Frager)
Introduction of an Adulterated Device into Interstate Commerce, in violation of Title 21, United States Code, Sections 331(a), 333(a)(1) and 351(e) and (f), a misdemeanor
Food and Drug Administration, Office of Criminal Investigations
U.S. Postal Inspection Service
Immigration and Customs Enforcement, Homeland Security Investigations