FDA Continues Effort to Protect Public Health from Fraudulent and Potentially Harmful Products
| SILVER SPRING, Md., April 17, 2020 /PRNewswire/ -- A federal court has entered an emergency temporary restraining order and a preliminary 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 emergency relief, the court found that the United States was likely to be able to prove 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 that, when combined with the included activator, has a chlorine dioxide content equivalent to industrial bleach, and that they would continue violating the law unless immediately enjoined. “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 treatments. The FDA and FTC requested that the company respond within 48 hours describing the specific steps it has taken to correct the violations. In response to the warning letter, the defendants made clear that they had no intention of taking corrective action and would continue to sell MMS in violation of the law. This is especially concerning to the agency as the FDA has received reports of people experiencing serious adverse events, including respiratory failure, life-threatening low blood pressure, acute liver failure and QT prolongation after drinking certain chlorine dioxide products. The FDA has not approved Genesis’s product for any use, despite the defendants’ claims that these products can be used to cure, mitigate, treat or prevent diseases such as COVID-19, Alzheimer’s, autism, brain cancer, multiple sclerosis and HIV/AIDS. Claims made on the Genesis websites, which provide a link to purchase MMS, include, “The Coronavirus is curable, you believe that? . . . MMS will kill it.” The agency is not aware of any scientific evidence supporting the safety or efficacy of MMS to treat any disease and there are no approved drug applications in effect for the defendants’ MMS. As a result of these violations, today, U.S. District Judge Kathleen M. Williams for the U.S. District Court for the Southern District of Florida, entered the temporary restraining order and preliminary injunction against Genesis and the individual defendants Mark Grenon, Joseph Grenon, Jordan Grenon and Jonathan Grenon. The complaint, filed by the U.S. Department of Justice (DOJ), against the Bradenton, Fla. seller and the seller’s most responsible individuals, restrains and enjoins all defendants from labeling, holding and distributing unapproved new drugs and misbranded drugs, including MMS, in interstate commerce on a temporary basis. The FDA requested the DOJ to bring this case on behalf of the U.S. Government. The claims made in the complaint are allegations that, if the case were to proceed to trial, the government must prove to receive a permanent injunction against Genesis. The FDA is particularly concerned that products that claim to cure, 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 treat or prevent COVID-19. The FDA reminds the public to seek medical help from their health care providers. Additionally, children are a vulnerable population that may be at greater risk for adverse reactions from consuming chlorine dioxide products. The FDA encourages health care professionals and consumers to report adverse events or quality problems experienced with the use of COVID-19 products to the FDA’s MedWatch Adverse Event Reporting program. The FDA continues to monitor social media, online marketplaces and incoming complaints to help ensure that sellers do not continue to sell fraudulent products related to COVID-19. Additional Resources:
Media Contact: Jeremy Kahn, 301-796-8671 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.
SOURCE U.S. Food and Drug Administration |
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