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.
“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. “The department will work closely with the FDA to stop anyone attempting to take advantage of the pandemic by selling unapproved, misbranded drugs.”
“The FDA will continue to aggressively pursue and hold accountable those who jeopardize public health,” said Acting Deputy Director Greg Noonan for the FDA’s Office of Dietary Supplement Programs. “Today’s consent decree demonstrates that we will use all of our authority to stop companies that prey on the public during a global pandemic by selling unapproved new drugs.”
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.
The enforcement action was prosecuted by Trial Attorney Brianna M. Gardner of the Civil Division’s Consumer Protection Branch, with assistance from Associate Chief Counsel for Enforcement Jaclyn Martínez Resly of the FDA’s Office of Chief Counsel.
On May 17, 2021, the Attorney General established the COVID-19 Fraud Enforcement Task Force to marshal the resources of the Department of Justice in partnership with agencies across government to enhance efforts to combat and prevent pandemic-related fraud. The Task Force bolsters efforts to investigate and prosecute the most culpable domestic and international criminal actors and assists agencies tasked with administering relief programs to prevent fraud by, among other methods, augmenting and incorporating existing coordination mechanisms, identifying resources and techniques to uncover fraudulent actors and their schemes and sharing and harnessing information and insights gained from prior enforcement efforts. For more information on the department’s response to the pandemic and efforts to stop COVID-19 fraud, please visit https://www.justice.gov/coronavirus.
Anyone with information about allegations of attempted fraud involving COVID-19 can report it by calling the Department of Justice’s National Center for Disaster Fraud (NCDF) Hotline at 866-720-5721 or via the NCDF Web Complaint Form at: https://www.justice.gov/disaster-fraud/ncdf-disaster-complaint-form.
Additional information about the Consumer Protection Branch and its enforcement efforts may be found at http://www.justice.gov/civil/consumer-protection-branch.
Official news published at https://www.justice.gov/opa/pr/district-court-orders-new-jersey-defendants-stop-distributing-unapproved-nano-silver-products