MARTINSBURG, WEST VIRGINIA - Rebuilder Medical Technologies, Inc., a skin care business operating in Jefferson County, West Virginia, was ordered today to pay a fine in the amount of $10,000 and placed on probation for one year after it distributed 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. 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 in May 2015 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.
Assistant U.S. Attorney Paul Camilletti prosecuted the case on behalf of the government.
Chief U.S. District Judge Gina M. Groh presided.
Source: U.S. Department of Justice, Office of the United States Attorneys
