Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary
Compounding Law; Health Care; Awareness of all Types of Compounding Issues;
Pharmacy Benefit Managers (PBMs), Outsourcing Facilities
Food and Drug Administration and Compliance Issues
The U.S. Food and Drug Administration (FDA) continued to take action in the ongoing response 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.
As of today, 288 tests are authorized by the FDA under EUAs; these include 223 molecular tests, 58 antibody tests, and 7 antigen tests.