Ralph Fucetola of Newton and his partner, Rima Laibow, formerly of Croton-on-Hudson, sold a product that they claimed would "cure, mitigate, treat or prevent" the coronavirus, the Justice Department said Tuesday.
They claimed that anyone who ingested one capful a day of "Dr. Rima Recommends Nano Silver 10PPM" should have "no fear or concern" about the coronavirus, a complaint on file in U.S. District Court in Newark says.
The permanent injunction against Fucetola, Laibow and their company, Natural Solutions Foundation, stems from a suit filed against them by the Justice Department last year.
It not only stops them from selling the product -- the order also requires a recall of nano silver products they sold and the destruction of any left in inventory. Before distributing any drugs in the future, they also must notify the FDA in advance, "comply with specific remedial measures set forth in the injunction and permit FDA to inspect their facilities and procedures," under a consent order with the government.
Nano silver -- also known as colloidal silver -- contains silver particles suspended in liquid. It's sold as a dietary supplement and alternative-medicine cure for a variety of conditions.
It's never been approved as a treatment for anything, much less COVID-19, however, the Food and Drug Administration said.
Nano silver "is not generally recognized by qualified experts as safe and effective to prevent, treat or cure COVID-19" and the defendants’ claims "were not supported by credible scientific evidence or studies," the federal complaint says.
The products were also misbranded drugs, "because their labeling failed to bear adequate directions for use, as required by the FDCA," it adds.
It's not the first time that Fucetola -- who once touted himself as "The Vitamin Lawyer" -- and his partner, whose license reportedly lapsed, have drawn federal fire. They previously sold nano silver as a cure for Ebola.
Rather than face prosecution for violating the federal Food, Drug and Cosmetic Act (FDCA) with their COVID cure, Fucetola and Laibow agreed on the injunction as part of a consent decree with the government.
“Marketing unproven products as treatments for COVID-19 endangers public health and violates the law,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division.
"We will use all of our authority to stop companies that prey on the public during a global pandemic by selling unapproved new drugs,” added Acting Deputy Director Greg Noonan of the FDA’s Office of Dietary Supplement Programs.
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