Skin care business convicted of selling misbranded, unauthorized medical products
MARTINSBURG, WEST VIRGINIA - Rebuilder Medical Technologies, Inc., a skin care business operating in Jefferson County, West Virginia, was convicted in federal court today of distributing medical products without the approval of the U.S. Food and Drug Administration, United States Attorney William J. Ihlenfeld, II, announced.
An FDA investigation revealed that Rebuilder was manufacturing and distributing SilverCure Ointment, a product containing colloidal silver for use in treating molluscum, psoriasis, and other skin conditions. The FDA has not approved drugs containing colloidal silver due to concerns over lack of effectiveness and side effects such discoloration of the skin resulting from an accumulation of silver or silver sulfide.
"In 1999, the FDA notified the public that colloidal silver is not generally recognized as safe or effective and is an unapproved new drug. This form of silver in drugs that are readily available presents a clear threat to the public health," said Antoinette V. Henry, Special Agent in Charge, FDA Office of Criminal Investigations' Metro Washington Field Office. "The FDA will continue to work to remove such potentially dangerous products from the U.S. marketplace and to bring to justice those who attempt to evade regulatory scrutiny."
The company’s owners represented to the FDA that the businesses would discontinue the production and sale of products containing colloidal silver. However, the company continued to sell the unauthorized products.
Rebuilder Medical Technologies, Inc. pled guilty today to one count of "Introduction into Interstate Commerce of an Unapproved New Drug." David B. Phillips, a Rebuilder executive, executed the plea agreement on behalf of the company. The corporation faces a fine of up to $250,000.00 and a period of probation between one and five years. Under the Federal Sentencing Guidelines, the actual sentence imposed will be based upon the seriousness of the offenses and the prior criminal history, if any, of the defendant.
Assistant U.S. Attorney Paul Camilletti prosecuted the case on behalf of the government.
U.S. Magistrate Judge Robert W. Trumble presided.