April 13, 2020 – The Food and Drug Administration (FDA) is responding to the challenges of COVID-19 in new ways that streamline product review and policy approaches, while also ensuring that entities promoting unapproved products that claim to be effective against the virus do not go unchecked. Last week, the FDA and the Federal Trade Commission (FTC) sent Warning Letters to both Alex Jones’ Infowars and the Genesis 2 Church for promoting unapproved and misbranded products they claim will help treat COVID-19. These enforcement actions join others sent by the agency in recent weeks.
“The coronavirus pandemic poses multiple challenges for the FDA, not the least of which is to combat unproven or misleading claims for products purporting to prevent or alleviate Covid-19 infection,” said Coalition for Healthcare Communication Executive Director Jon Bigelow. “With coronavirus on our minds 24/7, the public is eager for ways to avoid infection and, unfortunately, there are people trying to play on the worst fears by circulating misinformation on social media and the Internet.”
An April 8 Warning Letter to Genesis 2 Church from the FDA and the Federal Trade Commission (FTC) calls out the church’s website and blog claims for “Miracle Mineral Solution” (MMS) (chlorine dioxide) which misleadingly state that taking MMS is “safe and/or effective to cure, mitigate, treat or prevent COVID-19.”
An April 9 FDA-FTC Warning Letter to media personality Alex Jones about his Infowars and related websites states that claims for several products – “Superblue Silver Immune Gargle,” “SuperSilver Whitening Toothpaste,” “SuperSilver Wound Dressing Gel,” and “Superblue Fluoride Free Toothpaste” – establish the intended use of the products and “misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19.”
In both of these Warning Letters, the agencies state that the claims cited render the products unapproved, misbranded new drugs. The agencies request that immediate action be taken – within 48 hours – to correct these violations, and state that if these actions are not taken, legal action, including seizure, injunctions and consumer refunds, could ensue. The FDA also has placed these entities on its list of companies selling fraudulent COVID-19 products, which is available online, until corrective actions have been taken. As of April 13, these two entities remain on that list.
It is worth noting that the Department of Justice recently filed an action seeking a temporary restraining order for a website which advertised fraudulent World Health Organization COVID-19 vaccine kits, and charged the operators of the website with wire fraud. Additionally, the Department of Health and Human Services Office of Inspector General recently published a fraud alert regarding a scam about COVID-19 test kits directed to Medicare recipients.
Beyond its Warning Letters, the FDA is continuing to explore innovative ways to bring emerging COVID-19 products to the market. After President Donald J. Trump declared a national emergency that he said would allow the Department of Health and Human Services to waive provisions of applicable laws and regulations to provide maximum flexibility to respond to the virus, newly confirmed FDA Commissioner Stephen Hahn announced that the first phase of clinical trials for a COVID-19 vaccine was underway, and that a vaccine could be ready in 12 months.
The agency also is working with more than 300 diagnostic test developers and more than 170 labs are conducting tests under FDA guidance. Further, the FDA is coordinating national efforts to develop two investigational blood-related therapies – convalescent plasma and hyperimmune globulin – which harness antibody-rich blood products made from blood donated by people who have recovered from the virus. Among other actions, the FDA has issued 33 emergency use authorizations to date, is reviewing clinical study protocols within 24 hours, and has redeployed medical and regulatory staff to serve on review teams.
On March 31, the FDA issued guidance on its “Coronavirus Treatment Acceleration Program (CART),” under which it will be “using every tool at the agency’s disposal to bring new therapies to sick patients as quickly as possible, while at the same time supporting research to further evaluate whether these medical countermeasures are safe and effective for treating patients infected with this novel virus,” according to an FDA press release.
The agency also has stated that it “recognizes the potential for many different real-world data sources to complement traditional clinical studies and speed the process of evaluating the impact of potential COVID-19 therapies. To that end, the agency is advancing relationships with partners in the public and private sectors to rapidly collect and analyze information in areas such as illness patterns and treatment outcomes.”
On April 2, the agency updated its recently released FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID-19 Pandemic.