A federal court permanently enjoined Natural Solutions Foundation, a New Jersey entity, and its principals from distributing unapproved and misbranded drugs that were marketed as a treatment for COVID-19. The company was distributing a “nano silver” product that they claimed would prevent, treat, or cure COVID-19. 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.
The complaint was filed at the request of the FDA, and states that nano silver is not generally recognized by qualified experts as safe and effective to prevent, treat, or cure COVID-19, and that these claims are not supported by credible scientific evidence or studies. And because the labeling did not have adequate instructions for use, the products are alleged to be misbranded drugs.
The defendants have agreed to settle the suit and be bound by a consent decree of permanent injunction. A recall must be issued for the nano silver products that they sold. Any such products remaining in the company’s possession must be destroyed. And before they can make or market any drug in the future, Natural Solutions Foundation must notify the FDA in advance, comply with specific remedial measures detailed in the injunction, and let the FDA inspect their facilities and procedures.
Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division said in a statement, “Marketing unproven products as treatments for COVID-19 endangers public health and violates the law. The department will work closely with the FDA to stop anyone attempting to take advantage of the pandemic by selling unapproved, misbranded drugs.”
On May 17, 2021, the Attorney General established the COVID-19 Fraud Enforcement Task Force so the Department of justice could partner with other government agencies to prevent fraud. Anyone with information about allegations of alleged 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 fill out a web complaint form.
