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FDA Coronavirus (COVID-19) Update: July 9th, 2020

 

U.S. Food and Drug Administration (FDA)Silver Spring, MD – The U.S. Food and Drug Administration (FDA) has announced the following actions taken in its ongoing response effort to the COVID-19 Coronavirus pandemic:

As part of the FDA’s effort to protect consumers, the agency issued a warning letter to one company for selling fraudulent COVID-19-related products.

Coronavirus.

Coronavirus.

The company, Ionogen, LLC, offers “Ionopure Skin & Hands” for sale in the United States with misleading claims that the products can mitigate, prevent, treat, diagnose, or cure COVID-19 Coronavirus in people.

There are currently no FDA-approved products to prevent or treat COVID-19 Coronavirus. Consumers concerned about COVID-19 Coronavirus should consult with their health care provider.

Today, federal prosecutors in Miami charged four Florida residents who allegedly marketed “Miracle Mineral Solution (MMS),” a toxic bleach, as a cure for COVID-19 Coronavirus, with conspiracy to defraud the United States, conspiracy to violate the Federal Food, Drug, and Cosmetic Act, and criminal contempt.

In prior warning statements, the FDA has strongly urged consumers not to purchase or use MMS, explaining that drinking MMS is the same as drinking bleach and can cause dangerous side effects, including severe vomiting, diarrhea, and life-threatening low-blood pressure.

As alleged in the criminal complaint, the defendants sold this dangerous product under the guise of Genesis II Church of Health and Healing (“Genesis”), an entity they allegedly created in an attempt to avoid government regulation of MMS. The FDA’s Office of Criminal Investigations conducted this investigation, with assistance from the Office of Chief Counsel.

“The Genesis II Church of Health and Healing has actively and deliberately placed consumers at risk with their fraudulent Miracle Mineral Solution and Americans expect and deserve medical treatments that have been scientifically proven to be safe and effective,” said Catherine Hermsen, Assistant Commissioner of the FDA’s Office of Criminal Investigations. “We commend the efforts of our law enforcement partners for vigorously investigating this matter. The FDA will continue our efforts to make sure these and other like-minded sellers do not jeopardize the health of Americans during this pandemic and in the future.”

FDA is alerting consumers and health care professionals that additional hand sanitizer products have been added to the agency’s list of products with confirmed and potential methanol contamination. Consumers should check their hand sanitizer products to determine if a product is on this list. Methanol is not an acceptable ingredient for hand sanitizer products and can be toxic when absorbed through the skin as well as life-threatening when ingested.

FDA is aware of reports of adverse events associated with hand sanitizer products, including those contaminated with methanol. FDA encourages health care professionals, consumers, and patients to report adverse events or quality problems experienced with the use of hand sanitizers to FDA’s MedWatch Adverse Event Reporting program. (When reporting such events, please provide the agency with as much information as possible to identify the product).

 


 

Testing updates:

To date, the FDA has currently authorized 169 tests under EUAs; these include 141 molecular tests, 26 antibody tests, and 2 antigen tests.

About the U.S. Food and Drug Administration

The U.S. Food and Drug Administration (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.


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