Disinformation about COVID-19 Preventions and Treatments: Analysis of USFDA Warning Letters

COVID-19 poses a challenge beyond the virus itself, in that lockdown has been associated increased use of the internet and social media. Disinformation about prevention and treatment strategies for COVID-19 can have lethal consequences. The United States Food and Drug Administration (USFDA) is currently monitoring the compliance of manufacturing firms as well as medicinal product advertisers to the Federal Food, Drug, and Cosmetic Act, 21 USC 321(h) regulations. In the event of noncompliance in the form of advertising products without prior USFDA approval for specific indications, doses, or route of administration, warning letters (WLs) are issued. WLs are intended to address the concerns identified by USFDA and encourage the recipient to take corrective steps to avoid similar instances in the future. We analyzed 182 WLs that were issued for noncompliance with drugs/devices related to either treatment, prevention, or testing of COVID-19 infections. The medicinal product website was identified as the major source of disinformation, followed by disseminated information on Facebook, Twitter, and Instagram. Nearly four-fifths were related to drugs, followed by devices and biologicals. Several biologicals, as well as allopathic, herbal, and non-herbal drugs were identified in the WLs. We observed that noncompliance with the USFDA regulations in terms of advertising a variety of products for prevention and treatment of COVID-19 infection was widely prevalent. More efforts are required by the respective national drug regulatory authorities to initiate or continue their monitoring of disinformation that may have lethal consequences.

Automated summary

COVID-19 has brought about an increase in internet and social media usage during lockdowns, leading to the spread of disinformation regarding prevention and treatment strategies. Websites promoting medicinal products were found to be the major source of such disinformation, followed by social media platforms like Facebook, Twitter, and Instagram. Noncompliance with FDA regulations was prevalent in the promotion of various products for COVID-19 prevention and treatment. It is crucial for national drug regulatory authorities to intensify their efforts in monitoring and addressing this issue to prevent potentially lethal consequences.