Other safety alerts
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| The United States: 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 |
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The US Food and Drug Administration (FDA) announces that 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.
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. 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.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-federal-judge-enters-temporary-injunction-against-genesis-ii-church
In Hong Kong, Miracle Mineral Solution is not a registered pharmaceutical product. Related news was previously issued by various overseas drug regulatory authorities, and was posted on the Drug Office website since 2 Aug 2010, with the latest update posted on 9 Apr 2020.
Ends/ Saturday, Apr 18, 2020
Issued at HKT 12:30
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