Natural Solutions Foundation and its trustees, Ralph Fucetola and Dr. Rima Laibow, agreed to settle the suit and be bound by a consent decree of permanent injunction.
The Food and Drug Administration (FDA) sent a warning letter in May 2020 alleging that the company’s website was offering a line of “Dr. Rima RecommendsTM Nano Silver 10 PPM” products that were “unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act” because they were intended to mitigate, prevent, treat, diagnose, or cure COVID-19.
This was followed on November 13, 2020 by the filing of a complaint at the request of the FDA against Natural Solutions Foundation, Fucetola and Laibow. The complaint also alleged that nano silver is not generally recognized by qualified experts as safe and effective to prevent, treat or cure COVID-19, and that the defendants’ claims were not supported by credible scientific evidence or studies.
In addition, the complaint alleged that the defendants’ nano silver products were misbranded drugs, because their labeling failed to bear adequate directions for use, as required by the FDCA.
“Marketing unproven products as treatments for COVID-19 endangers public health and violates the law,” said Acting Assistant Attorney General Brian M. Boynton of the Justice Department’s Civil Division. “The department will work closely with the FDA to stop anyone attempting to take advantage of the pandemic by selling unapproved, misbranded drugs.”
“The FDA will continue to aggressively pursue and hold accountable those who jeopardize public health,” added Greg Noonan, Acting Deputy Director for the FDA’s Office of Dietary Supplement Programs. “Today’s consent decree demonstrates that we will use all of our authority to stop companies that prey on the public during a global pandemic by selling unapproved new drugs.”
As part of the settlement, the defendants agreed to recall the nano silver products they sold and destroy any remaining inventory. Moreover, the defendant agreed to notify the FDA before distributing any new drugs, and the Agency must be allowed to inspect their facilities and procedures.
This isn’t the first time Natural Solutions Foundation has allegedly crossed the line regarding claims, having received a warning letter from the FDA in 2014 regarding products claiming to cure or prevent Ebola.