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
Friday, April 17, 2020
Coronavirus (COVID-19) Update: Federal judge enters temporary injunction against Genesis II Church of Health and Healing, preventing sale of Chlorine Dioxide Products Equivalent to Industrial Bleach to Treat COVID-19 FDA Continues Effort to Protect Public Health from Fraudulent and Potentially Harmful Products
A federal court has entered a temporary injunction against the Genesis II Church of Health and Healing (Genesis) and four individuals associated with the entity requiring them to immediately stop distributing its “Miracle Mineral Solution” (MMS), an unproven and potentially harmful treatment offered for sale to treat Coronavirus, which includes Coronavirus Disease 2019 (COVID-19) and many other diseases. In granting the government’s request for relief, the court found that the United States has demonstrated that Genesis and the associated individuals named in the injunction are violating the Federal Food, Drug, and Cosmetic Act (FD&C) by unlawfully distributing MMS, an unapproved new drug and misbranded drug. When combined with the included activator MMS has a chlorine dioxide content equivalent to industrial bleach. The court also found that there is a danger that the defendants will continue violating the law without the temporary restraining order.
“Americans expect and deserve proven medical treatments and today’s action is a forceful reminder that the FDA will use its legal authorities to quickly stop those who have proven to continuously threaten the health of the American public. It is vital that sellers of drug products comply with the FD&C Act and do not sell products with false and misleading claims, especially to treat COVID-19 and other debilitating diseases, such as autism and Alzheimer’s Disease,” said FDA Commissioner Stephen M. Hahn, M.D. “Despite a previous warning, the Genesis II Church of Healing has continued to actively place consumers at risk by peddling potentially dangerous and unapproved chlorine dioxide products. We will not stand for this, and the FDA remains fully committed to taking strong enforcement action against any sellers who place unsuspecting American consumers at risk by offering their unproven products to treat serious diseases.”
The FDA, jointly with the Federal Trade Commission (FTC), previously issued a warning letter to Genesis and the FDA has warned consumers numerous times over the past decade not to purchase or drink chlorine dioxide products such as MMS sold as medical...