Welcome
Pharma & Life Sciences

1,100 Phony Covid-19 Products Flagged by FDA During Pandemic

Nov. 12, 2020, 8:47 PM

Covid-19 quacks and snake oil salesmen have been busy since the spring peddling 1,100 phony virus products, according to FDA data.

The Food and Drug Administration found more than 1,100 “fraudulent and unproven medical products related to Covid-19" as of September, Anand Shah, the FDA’s deputy commissioner for medical and scientific affairs said Thursday. The agency has sent 120 warning letters to sellers, 230 reports to online marketplaces, and more than 270 complaints to domain registrars over the course of the pandemic.

“It is an unprecedented number that they have flagged that many products all related to Covid-19" in such a short time period, said Carolina Wirth, an attorney at Arnall Golden Gregory LLP in Washington and former regulatory counsel at the FDA’s Center for Drug Evaluation and Research’s Office of Regulatory Policy.

Fraudulent products highlight the anxiety the public feels about Covid-19 as well as the steady stream of fake facts fed to Americans daily. The prevalence of unchecked social media posts and unproven statements by some political officials have made it easier to mislead people about what works against the virus.

“The emergence of fraudulent medical products is a common phenomena in crisis situations,” Shah said. The FDA created a task force with the Centers for Disease Control and Prevention, the Justice Department, and the Federal Trade Commission in March called ‘Quack Hack’ to promote consumer safety and combat phony products.

Although the amount of fake cures or preventives are high, the agency is doing its best to combat bad actors, Wirth said.

Response Time Sped Up

The agency, as part of its effort to fight fake cures, has cut back on the time companies get to respond to warning letters.

Companies that typically get 15 days to respond now have 48 hours, Wirth said. The federal government has also taken companies to court for refusing to take down misleading claims about their products.

Cases against companies making dubious marketing claims aren’t uncommon, but it’s rare that the cases are against allegedly dangerous products. One such case involved the Genesis II Church of Health and Healing, which sold a chlorine dioxide product it claimed could cure the coronavirus.

After receiving a warning letter, the group continued to sell its “Miracle Mineral Solution” whose chlorine dioxide content was equivalent to “industrial bleach,” according to the FDA. Adverse reactions to those types of products include “respiratory failure, life-threatening low blood pressure, and acute liver failure,” the FDA said.

In August, a Florida judge barred the Genesis II Church and its leaders from selling or distributing “unapproved or misbranded products” such as Mineral Miracle Solution.

Though fraud during emergencies is common, Covid-19 fraud is especially bad because other health emergencies like Ebola in the U.S. or H1N1 were smaller and contained faster, Wirth said. “There was a lot less information given to the public to confuse consumers what to do and what to take and not to take.”

To contact the reporter on this story: Jacquie Lee in Washington at jlee1@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloombergindustry.com; Alexis Kramer at akramer@bloomberglaw.com

To read more articles log in. To learn more about a subscription click here.