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April 8, 2020: FDA Issues Warning Letter to Genesis II Church for Selling Fraudulent Products related to Coronavirus (COVID-19)

Genesis II Church Warning Letter News – The U.S. Food and Drug Administration (FDA) has issued a warning letter to Genesis II Church of Health and Healing regarding its marketing of fraudulent and dangerous chlorine dioxide products known as “Miracle Mineral Solution” as a means of prevention and treatment of the “Novel Coronavirus Disease 2019” (COVID-19).

Genesis II Church Warning Letter Information

On April 8, 2020, the FDA issued a warning letter to Genesis II Church for its marketing of “Miracle Mineral Solution” as a treatment and cure for COVID-19. The FDA is not aware of any scientific evidence supporting the safety or effectiveness of chlorine dioxide products sold online as medical treatments and, further, they pose significant risks to patient health.

Per the FDA:

“Despite previous warnings, the FDA is concerned that we are still seeing chlorine dioxide products being sold with misleading claims that they are safe and effective for the treatment of diseases, now including COVID-19. The sale of these products can jeopardize a person’s health and delay proper medical treatment,” said FDA Commissioner Stephen M. Hahn, M.D. “We continue to take action and keep up our efforts to monitor for fraudulent treatments during this public health emergency and remind the public to seek medical help from their health care providers.”

The warning letter to Genesis II Church was issued in conjunction with the Federal Trade Commission (FTC) for fraudulently claiming that the chlorine dioxide products they sell can prevent or treat COVID-19 in children and adults. It is important to note that children are especially vulnerable to adverse reactions from consuming chlorine dioxide. The FDA and FTC gave Genesis II Church 48 hours to respond with specific steps they are taking to correct these violations.

Per the FDA, companies selling chlorine dioxide products usually describe the product as a liquid that is 28% sodium chlorite in distilled water. Product directions instruct consumers to mix the sodium chlorite solution with citric acid (such as lemon or lime juice), or another acid (such as hydrochloric acid) before drinking. Business might also sell the sodium chlorite as part of a kit with a citric acid “activator.” When the acid is added, the mixture becomes chlorine dioxide, a powerful bleaching agent that has caused serious and potentially life-threatening side effects.

The FDA and FTC have warned that if companies sell products with unapproved claims to prevent, treat or cure COVID-19, they may be subject to enforcement action, including but not limited to seizure or injunction.

Life-Threatening Adverse Events

The FDA has received reports of people experiencing serious adverse events after ingesting chlorine dioxide products, including:

  • Respiratory failure caused by a serious condition where the amount of oxygen carried through the blood stream is greatly reduced (methemoglobinemia);
  • Changes in the electrical activity of the heart (QT prolongation), which may lead to potentially fatal abnormal heart rhythms;
  • Life-threatening low blood pressure caused by dehydration;
  • Acute liver failure;
  • Low blood cell counts, due to the destruction of red blood cells faster than the body can make it (hemolytic anemia), which required a blood transfusion;
  • Severe vomiting; and
  • Severe diarrhea

Credit: FDA

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