The United States District Court for the District of New Jersey ordered a company and ints principals to cease distribution of a product touted as a COVID-19 treatment on Tuesday, according to the Department of Justice (DOJ), because the product was misbranded and unapproved.

The DOJ said that the company Natural Solutions Foundation and its trustees, Ralph Fucetola and Dr. Rima Laibow, agreed to settle a lawsuit against it and be bound by a consent decree imposing a permanent injunction. In a complaint filed at the request of the US Food and Drug Administration (FDA) last month, the DOJ alleged that Natural Solutions Foundation and its two principals violated the Federal Food, Drug, and Cosmetic Act (FDCA). The complaint alleged that Fucetola and Dr. Laibow had introduced a new COVID-19 drug into interstate commerce without gaining approval, and that the drug had been misbranded under the act. 

According to the complaint, Natural Food Solutions distributed a “nano-silver” product that it claimed would help prevent, treat and cure COVID-19. These drugs, which purportedly contained silver particles in a solution, were marketed through several websites with names like drrimatruthreports.com and truthaboutcoronavrius.com and were sold starting in January 2020. But the DOJ argued that such solutions are not generally recognized as safe or effective by qualified experts. Further, the DOJ stated that the company’s claims were not backed by sufficient, credible scientific evidence and that they were mislabeled as drugs because their labeling failed to bear adequate directions for use, as required by the FDCA.

Acting Deputy Director Greg Noonan of the FDA’s Office of Dietary Supplement Programs said in a statement that “[t]he FDA will continue to aggressively pursue and hold accountable those who jeopardize public health.”  Noonan also applauded the outcome of this case, saying that the “consent decree demonstrates that [the DOJ] will use all of [its] authority to stop companies that prey on the public during a global pandemic by selling unapproved new drugs.”

The consent decree permanently enjoins Natural Food Solutions, Fucetola and Dr. Laibow from committing further FDCA violations and requires it to submit a recall plan to the FDA by January 2 for the “nano-silver” product. Once the FDA approves, they will have 22 days to complete the recall. They must then destroy any nano-silver products in their possession under the FDA’s supervision.

Natural Food Solutions, Fucetola and Dr. Laibow must also give the FDA advance notice if they plan to distribute any drugs in the future and must continue to allow the FDA to inspect their procedures and facilities.