What is Operation Quack Hack?

Operation Quack Hack is a task force launched by the U.S. Food and Drug Administration (FDA) in March 2020 to combat the sale and distribution of unapproved and potentially harmful products that claim to prevent, treat, diagnose or cure COVID-19. The task force consists of FDA staff from various offices, including the Office of Criminal Investigations, the Office of Regulatory Affairs, the Office of Chief Counsel, and the Center for Drug Evaluation and Research.

According to the FDA, Operation Quack Hack has identified hundreds of such products, including fraudulent drugs, testing kits, personal protective equipment, and dietary supplements. The task force has taken action against these products by issuing warning letters, injunctions, seizures, and criminal charges. The task force has also worked with online platforms, domain registrars, payment processors, and social media companies to remove or block fraudulent products from reaching consumers.

Why is Operation Quack Hack important?

Operation Quack Hack is important because it protects the public health and safety from products that may be ineffective, harmful, or even deadly. The FDA warns that these products may cause serious adverse effects, such as organ damage, allergic reactions, or drug interactions. They may also delay or interfere with proper diagnosis and treatment of COVID-19. Furthermore, these products may undermine the public confidence in the FDA-approved products and treatments that are proven to be safe and effective.

Operation Quack Hack is also important because it supports the FDA’s mission to ensure the availability and quality of critical medical products during the COVID-19 pandemic. The task force helps to prevent the diversion of resources and supplies from legitimate sources and to preserve the integrity of the FDA’s regulatory process. By cracking down on fraudulent products, Operation Quack Hack helps to ensure that consumers have access to accurate and reliable information and products that can help them fight COVID-19.

What are some examples of Operation Quack Hack’s actions?

Operation Quack Hack has taken various actions against different types of fraudulent products and actors. Here are some examples:

– In July 2020, the FDA raided the headquarters of the Genesis II Church of Health and Healing in Florida, which sold a product called Miracle Mineral Solution (MMS), a bleach-like substance that claimed to cure COVID-19 and other diseases. The FDA arrested four members of the church’s family leadership and charged them with conspiracy and contempt.
– In August 2020, the FDA issued a warning letter to Dr. Stella Immanuel, a physician who promoted hydroxychloroquine as a cure for COVID-19 in a viral video. The FDA stated that hydroxychloroquine is not approved for COVID-19 and may cause serious side effects.
– In September 2020, the FDA seized more than 100,000 counterfeit 3M N95 respirators from an Illinois warehouse. The FDA stated that these respirators did not meet the quality standards and could pose a health risk to health care workers and consumers.
– In October 2020, the FDA issued a warning letter to North Coast Biologics, a Seattle-based company that sold an unapproved antibody test for COVID-19. The FDA stated that the test was not authorized for emergency use and could produce false or inaccurate results.
– In November 2020, the FDA issued a warning letter to Whole Foods Market for selling products that claimed to prevent or treat COVID-19 without FDA approval. The products included elderberry syrup, colloidal silver, and oregano oil.

These are just some of the examples of Operation Quack Hack’s actions. The task force continues to monitor the online marketplace and take appropriate actions against fraudulent COVID-19 products. Consumers can report suspected fraud to the FDA through its website or by calling 1-888-INFO-FDA.

(1) FDA Protects Patients and Consumers from Fraud During COVID-19. https://www.fda.gov/news-events/fda-voices/fda-protects-patients-and-consumers-fraud-during-covid-19.
(2) Coronavirus (COVID-19) Update: FDA Continues to Combat Fraudulent COVID …. https://www.fda.gov/news-events/press-announcements/coronavirus-covid-19-update-fda-continues-combat-fraudulent-covid-19-medical-products.
(3) Covid Bleach Cure: How Operation Quack Hack Took Down the Genesis II …. https://www.bloomberg.com/news/features/2021-06-29/covid-bleach-cure-how-operation-quack-hack-took-down-the-genesis-ii-church.

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