FDA recalls nano silver supplements claiming to prevent, treat or cure COVID-19
14 Mar 2023 --- The US Food and Drug Administration (FDA) urges consumers to return the purchased “Dr. Rima Recommends Nano Silver 10 ppm dietary supplement” by 29 March 2023 for destruction and to be compensated with refund checks. The product is being recalled because it is labeled as a supplement with unsubstantiated health claims about immunity against COVID-19.
The product from Natural Solutions Foundation (NSF) was sold from 22 January 2020 to 27 December 2021. It allegedly contained silver particles in a solution. The FDA explains that consumers who use this product instead of seeking timely medical treatment risk severe and life-threatening health consequences.
The company agreed to destroy the recalled product and all nanosilver products, including components, raw and in-process materials and finished products, in the company’s possession, custody or control.
NSF was ordered to stop distributing the supplement. In the product recall, the FDA also requests retailers and distributors to cease distribution. The organization encourages supplement sellers to notify their customers of the product recall, as this needs to be carried out at the consumer level.
The voluntary recall is part of a consent decree from December 2021, when NSF settled with the FDA on a complaint for an injunction.
At the time, Greg Noon, acting deputy director for the FDA’s Office of Dietary Supplement Programs, explained, “we will use all of our authority to stop companies that prey on the public during a global pandemic by selling unapproved new drugs.”
Acting assistant attorney general Brian Boynton of the Justice Department’s Civil Division added, “marketing unproven products as treatments for COVID-19 endangers public health and violates the law.”
Unauthorized new drug
According to the FDA, NSF operates several websites selling supplements and has included unlawful claims.
One such claim regarding the coronavirus included, “support your immune function with my evidence-based, non-toxic Nano Silver 10 PPM. I take one cap full prophylactically once a day and have absolutely no fear or concern about coming down with whatever this, or any other, bug can do. None.”
According to the FDA, product claims made by the company were not supported by credible scientific evidence or studies. Moreover, qualified experts do not generally recognize nanosilver as safe and effective in preventing, treating or curing COVID.
The FDA further argues that NSF violated legislation by introducing an unapproved and misbranded new drug into commerce. Supplements that claim to treat, cure and prevent diseases are subject to the same requirements for drugs and must be approved by the FDA.
History of non-compliance
In 2014, the FDA issued a warning letter that included numerous claims by NSF that the same nanosilver food supplement was intended to cure, mitigate, treat or prevent Ebola. For example, the company stated that “nano silver was known as the definitive antiviral agent against Ebola virus.”
During inspections in 2018 and 2020, the FDA found the company continued to make similar claims on websites related to the supplement.
In 2020, the FDA informed NSF that it would file a lawsuit regarding the COVID-19 claims on its supplement. The company put the products on hold and continued making claims on the website and YouTube channel.
FDA has also issued warnings on another product used against COVID-19, ivermectin. Although the product is approved for human use to treat infections, it is not authorized to prevent or treat COVID-19. Clinical trials on ivermectin are ongoing.
FDA allows claims on supplements that include structure/function claims, a general well-being claim or a classical nutrient deficiency disease claim. Companies also need to substantiate that the statement is truthful and not misleading.
Claims must be accompanied by a standard disclaimer that the FDA has not evaluated the statement and that the product is not intended to diagnose, treat, cure or prevent any disease.
Experts previously criticized the FDA’s approach in removing dangerous supplements for being ineffective, as warning letters often go unheeded.
“The reason the supplement industry is unregulated is because any person with little to zero educational credibility can create a supplement company in their garage, slap a label on the product and sell it as an effective dietary supplement without any FDA approval,” Obi Obadike, founder of Ethical Inc, previously told NutritionInsight.
During the COVID-19 pandemic, consumption of supplements increased substantially, but experts warned that many people are uninformed about the products they are taking.
By Jolanda van Hal
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