MARTINSBURG, W.Va. (AP) - An Eastern Panhandle company faces a maximum $250,000 fine after admitting that it distributed medical products without federal approval.
Rebuilder Medical Technologies also faces up to five years of probation. The Jefferson County company pleaded guilty in U.S. District Court in Martinsburg to introducing an unapproved drug into interstate commerce.
David B. Phillips, a Rebuilder executive, executed a plea agreement on the company’s behalf, U.S. Attorney William J. Ihlenfeld II said.
Rebuilder was indicted in January on charges of manufacturing and distributing a drug for skin conditions that contained colloidal silver.
Drugs containing colloidal silver have not been approved by the FDA because of concerns over the substance’s lack of effectiveness and the risk of side effects such as skin discoloration, Ihlenfeld said in a news release.
Colloidal silver consists of small silver particles in a liquid, according to the National Center for Complementary and Integrative Health.
“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,” FDA Special Agent in Charge Antoinette V. Henry said in the release. “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.”
Ihlenfeld said Rebuilder continued selling products containing colloidal silver after its owners told the FDA that the company would stop production and sales.
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