A nutritional supplement that federal officials say was falsely advertised as a remedy for COVID-19 is being taken off the market, according to a corporate announcement released through the U. S. Food and Drug Administration. The U. S. Food and Drug Administration this week, years after the manufacturer got a similar reaction to an alleged Ebola remedy. .
The Natural Solutions Foundation’s recall of “Dr. Rima Recommends Nano Silver 10ppm” came after the federal government discovered that the product label and suppliers had made “unsubstantiated fitness claims that the product will prevent, treat, or cure COVID-19. “
The government has decided that consumers who use this “nanosilver” product, instead of seeking proper medical care and treatment, may face serious and/or life-threatening consequences for their physical condition, the recall says.
This is the first time the Natural Solutions Foundation and Rima Laibow, the company’s lead medical officer, have illegally distributed unapproved drugs, according to a complaint filed with the federal government in 2020.
Natural Solutions Foundations, Laibow and the company’s vice president of legal affairs, Ralph Fucetola, have in the past distributed “nanosilver” products with claims to cure or prevent other outbreaks, adding the Ebola outbreak in the mid-2010s, according to the complaint.
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In December 2021, a federal court ordered the Natural Solutions Foundation, along with trustees Fucetola and Laibow, to prevent the distribution of the unapproved and mislabeled “nano silver” product.
“Marketing unproven products as COVID-19 remedies jeopardizes public fitness and violates the law,” Brian M. Boynton, the current deputy assistant attorney general for the Justice Department’s civil division, said in a DOJ at the time. will work heavily with the FDA to prevent anyone from trying to profit from the pandemic by promoting unapproved and mislabeled drugs. “
In a November 2020 complaint, the United States alleged that Natural Solutions Foundation, Fucetola, and Laibow violated the Federal Food, Drug, and Cosmetic Act by distributing the unapproved product, which allegedly contained silver scraps in a solution.
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According to the lawsuit, “nanosilver is sometimes not identified through qualified experts as effective in preventing, treating, or curing COVID-19, and the defendants’ claims were not supported by clinical evidence or credible studies,” the Justice Department wrote.
According to the Justice Department’s December 2021 statement, the defendants agreed to settle the trial and be bound by a permanent injunction consent decree. The order required the defendants to destroy all the “nanosilver” and release a recall.
This week’s recall urges sellers to check their stock to see if they own the recalled product, avoid distribution and notify consumers of the recall.
Within 22 days of the company’s announcement date, known as March 7 on the FDA’s website, unused quantities of the product will be sent to the Natural Solutions Foundation front in Newton, New Jersey for a refund. More information can be found here.
“Dr. Rima Recommends Nano Silver 10ppm” sold from January 2020 to December 2021, according to the recall notice.
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Laibow and the Natural Solutions Foundation came under fire in the past in 2014, when the company was among those to receive warnings from the FDA and Federal Trade Commission for selling products claiming to be Ebola treatments, solutions or therapies.
Laibow advertised a “nanosilver” product and stuck to it following the FDA and FTC letter.
According to the 2020 complaint filed against the Natural Solutions Foundation, at the time of the 2014 warning letter, the defendants stated in their letter that nanosilver “was known. . . as the definitive antiviral agent opposed to Ebola. “
As of September 2020, the defendants were still making statements about nanosilver and Ebola on their website, according to the complaint.
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