A federal court permanently enjoined a New Jersey entity and its principals from distributing unapproved and misbranded drugs touted as a treatment for COVID-19.
In a complaint filed on Nov. 13, 2020, the United States alleged that Natural Solutions Foundation, along with trustees Ralph Fucetola and Dr. Rima Laibow, violated the Federal Food, Drug and Cosmetic Act (FDCA) by distributing a “nano silver” product that they claimed would prevent, treat or cure COVID-19.
According to the complaint, which was filed at the request of the U.S. Food and Drug Administration (FDA), Natural Solutions operated various websites to market “Dr. Rima Recommends Nano Silver,” a product that purportedly contained silver particles in a solution.
The complaint further alleged that nano silver is not generally recognized by qualified experts as safe and effective to prevent, treat or cure COVID-19, and that the defendants’ claims were not supported by credible scientific evidence or studies. Additionally, the complaint alleged that the defendants’ nano silver products were misbranded drugs, because their labeling failed to bear adequate directions for use, as required by the FDCA.
The defendants agreed to settle the suit and be bound by a consent decree of permanent injunction. The order entered by the federal court permanently enjoins the defendants from violating the FDCA and requires that they institute a recall for the nano silver products they sold and destroy any such products in their possession. Before distributing any drug in the future, the defendants must notify FDA in advance, comply with specific remedial measures set forth in the injunction and permit FDA to inspect their facilities and procedures.
