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FDA News Release

Coronavirus (COVID-19) Update: November 13, 2020

For Immediate Release:

The U.S. Food and Drug Administration today announced the following actions taken in its ongoing response effort to the COVID-19 pandemic:

  • At FDA’s request, the U.S. Department of Justice filed a civil complaint in the U.S. District Court for the District of New Jersey against Natural Solutions Foundation and two individuals associated with the entity, seeking to permanently enjoin them from distributing Dr. Rima RecommendsTM Nano Silver 10PPM in interstate commerce as a prevention or treatment for COVID-19 and other diseases. The complaint alleges that Natural Solutions Foundation and the individual defendants, Dr. Rima Laibow and Ralph Fucetola, violated the Federal Food, Drug, and Cosmetic Act by unlawfully distributing a misbranded and unapproved new drug. These are allegations which, if the case were to proceed to trial, the government must prove to receive a permanent injunction against defendants.

    FDA, jointly with the Federal Trade Commission (FTC), previously issued a warning letter to the defendants about their nano silver product. The defendants responded by removing some, but not all, public-facing claims from their websites.

    FDA is particularly concerned that products that claim to cure, mitigate, treat or prevent serious diseases like COVID-19 may cause consumers to delay or stop appropriate medical treatment, leading to serious and life-threatening harm. There are currently no vaccines or drugs approved to prevent COVID-19. FDA reminds the public to follow advice from federal agencies about how to prevent the spread of COVID-19 and urges people with questions about COVID-19 treatments to contact their health care provider.
  • Testing updates:
    • As of today, 288 tests are authorized by the FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.

 

The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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