In a civil complaint for permanent injunction filed November 13, 2020 in U.S. District Court for the District of New Jersey, the United States alleged that Natural Solutions Foundation, Dr. Rima Laibow, and Ralph Fucetola sold and distributed a nano silver product that the defendants claim will cure, mitigate, treat, or prevent COVID-19. Defendants’ nano silver product purportedly contains silver particles in a solution. According to the government’s complaint, nano silver is not generally recognized as safe and effective by qualified experts for the use promoted by the defendants.
“The Department of Justice will not allow individuals to take advantage of the ongoing public health emergency by peddling unproven, unapproved drugs,” said Acting Assistant Attorney General Jeffrey Bossert Clark of the Justice Department’s Civil Division. “We will continue to work closely with the Food and Drug Administration to halt the illegal sale of such products during this pandemic.”
“FDA will not hesitate to take strong action to enforce the Federal Food, Drug, and Cosmetic Act and protect the public from the unlawful distribution of products that have not been shown to be safe and effective in treating or preventing COVID-19,” said FDA Chief Counsel Stacy Amin. “Distributors of such products—especially those such as the defendants in this case, who have a history of violating the Act and, despite warning, failed to take prompt voluntary action to sufficiently correct their conduct—place unsuspecting American consumers at risk by offering their unproven products to treat serious diseases like COVID-19.”
The complaint alleges that the defendants introduced an unapproved new drug into interstate commerce, and that the disease claims defendants make lack support from well-controlled clinical studies or other credible scientific substantiation. Additionally, the complaint asserts that, because defendants’ product does not have adequate directions for lay users, the product is misbranded.
On May 19, 2020, FDA issued a joint Warning Letter with the Federal Trade Commission notifying the defendants that they violated the Federal Food, Drug, and Cosmetic Act by, among other things, distributing unapproved new drugs and misbranded drugs in interstate commerce. According to the complaint, the defendants removed certain claims regarding the nano silver product from their public-facing websites but failed to remove others.
In two other recent actions, the Department of Justice worked with FDA and other partners to halt the sale of silver products touted as COVID-19 treatments. In May, a federal court in the Eastern District of Oklahoma entered a temporary restraining order and then a preliminary injunction against Xephyr LLC, doing business as N-Ergetics, and its owners to stop the distribution of a colloidal silver product the defendants claimed would cure, mitigate, or treat COVID-19. In July, prosecutors obtained an indictment against Utah resident Gordon H. Pedersen alleging that he posed as a doctor to promote an ingestible silver-based product as a COVID-19 cure. In a related case, the company Pedersen previously co-owned, My Doctor Suggests LLC, agreed to plead guilty to a one-count criminal information.
The enforcement action is being prosecuted by Trial Attorney Brianna M. Gardner of the Department of Justice Civil Division’s Consumer Protection Branch, and Deputy Chief of the Government Fraud Section David Dauenheimer of the U.S. Attorney’s Office for the District of New Jersey, with assistance from Associate Chief Counsel for Enforcement Jaclyn Martínez Resly of the FDA, Office of General Counsel, Department of Health and Human Services.
The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove to receive a permanent injunction against the defendants.
