Food and Drug Administration
Office of Criminal Investigations
U.S. Department of Justice Press Release
For Immediate Release
November 13, 2009
United States Attorney
Western District of Washington
Contact: Emily Langlie
Public Affairs Officer
Burien Couple Tried to Bribe FDA Officer Over Radiation Emitting Device
TOAN LE, 51, and HANG HO, 41, a married couple residing in Burien, Washington, pleaded guilty today in U.S. District Court in Seattle in connection with their attempt to import and use a cosmetic device that had not been approved for use in the U.S. by the Food and Drug Administration. LE pleaded guilty to providing an Illegal Gratuity to Public Official and HO pleaded guilty to Introduction or Delivery for Introduction Into Interstate Commerce of Adulterated Device. When sentenced by U.S. District Judge Ricardo S. Martinez, LE faces up to two years in prison and HO faces up to one year in prison.
According to the records in the case, and the plea agreements signed today, TOAN LE owns Crystal Nails beauty salon in Burien, Washington, and HO is an employee of the salon. In July 2009, HO admits she attempted to import, into the United States, medical devices that had not been approved by the Food and Drug Administration. One of the devices was a "Skin Light Machine" -- a laser type device for skin treatment. The device emits radiation at unknown levels. When the FDA Consumer Safety Officer made an inspection, LE admits he offered first $500 and later $800 to allow the salon to keep the machine and other adulterated goods. On July 13, 2009, in Tukwila, LE delivered an envelope containing $800 to the Consumer Safety Officer. The officer was cooperating with law enforcement. Under the terms of the plea agreement, LE and HO forfeit the $800, as well as a variety of items from their salon which were adulterated or misbranded, including nine skin light machines, four hand held massagers, creams, bath salts and tweezers.
Each year in the United States, including the State of Washington, consumers are injured by individuals who are neither licensed or trained to perform medical procedures. Oftentimes, the people performing these cosmetic treatments use drugs and devices not approved by the FDA for use in the United States. The injuries range from severe burns, infection and permanent scaring. The FDA has investigated cases where some consumers have died after receiving such treatments from individuals not licensed to perform such procedures.
This was a joint investigation between the FDA Office of Criminal Investigations and U.S. Immigration and Customs Enforcement (ICE). Both the Washington State Department of Health and the Washington State Department of Licensing assisted with the investigation.
The case is being prosecuted by Assistant United States Attorneys Kathryn Warma and Mary K. Dimke.