The U.S. Department of Justice went to court Friday seeking to block a New Jersey company from selling a product officials said falsely claimed to cure, mitigate, treat, or prevent COVID-19, even as the deadly pandemic — which has no known cure — continues to spread wildly out of control across much of the country.
Attorneys for the government requested a restraining order to stop the sale and recommendation of what they said was an unapproved “nano silver” product that a Newton-based company “Natural Solutions Foundation” has been pushing as a cure to COVID-19, the illness caused by the coronavirus, the department said.
“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.
According to a complaint filed in U.S. District Court in Newark, the company claimed that by taking a daily dose of their “nano silver 10 ppm” product, sold as capsules, a person “should have no fear or concern” about coronavirus.” The lawsuit named the company, along with Rima Laibow, the company’s medical director, and Ralph Fucetola, the company’s vice president of legal affairs, as defendants.
“Defendants distributed their nano silver product accompanied, for example, by the claim that someone who takes ‘1 cap full . . . a day’ of their product should have ‘no fear or concern’ about coronavirus,” the lawsuit said.
It noted that the U.S. Food and Drug Administration “conducted comprehensive searches of the publicly available medical and scientific literature for nano silver and determined that there are no published, adequate and well-controlled studies” demonstrating that the company’s nano silver product was safe and effective for use under the conditions suggested in its labeling. Even after the government notified the company of its intent to sue, the lawsuit said the firm only removed some of the product claims related to COVID-19 from their websites, and put the product “on hold.”
In May, the company received a warning letter from the FDA and the Federal Trade Commission for their claims about the “nano silver” product’s effectiveness in treating COVID-19. The joint warning letter listed claims by the company that allegedly falsely reassured customers.
“Once you have access to The Silver Solution, Nano Silver 10 PPM, you have no reason to participate in the COVID-19 panic!” the company allegedly wrote on one of it websites.
It is not the first time the company has been warned by federal agencies to stop making false claims about their products’ effectiveness against swirling pandemics.
In 2014, Natural Health Solutions was warned by the FDA and the FTC to stop touting the same product, nano silver 10 PPM, as a cure for the ebola virus. At the time, Natural Health Solutions added a disclaimer on one of its websites that Nano Silver had not undergone FDA testing.
The lawsuit comes as the second wave of the coronavirus has arrived in New Jersey, and on the same day that the state tallied 3,399 more positive cases – near the peak of the virus back April. Vaccines from two pharmaceutical giants, Pfizer and Moderna, are reportedly effective based on trials and are being rushed to production distribution.