With the aim to contain and mitigate rapid spread, the global pandemic of the novel
coronavirus (COVID-19) has driven emerging technologies and diagnostic testing of severe acute respiratory syndrome-related coronavirus-2 (SARS-CoV-2) infections. Global efforts are needed to improve clinical testing capacity and provide prompt deployment of SARS-CoV-2 diagnostics to control the worldwide epidemic.
The Food and Drug Administration (FDA) has provided a policy-based guidance document to assist in accelerating the availability of COVID-19 diagnostic tests; however, the marketing and sale of fraudulent products related to COVID-19 have emerged. From March 6th to April 27th, 2020, the FDA has issued 37 warning letters for unapproved products claiming to cure, prevent, diagnose, mitigate, or treat COVID-19.
Of the warning letters issued, many were related to either cannabidiol (CBD), colloidal silver, essential oil, herbal teas, homeopathic drugs, or dietary supplement products. Unauthorized fraudulent COVID-19 testing kits have been noted to be marketed for at-home use, which may lead to consumers not seeking appropriate medical care. Unapproved and dangerous chlorine dioxide products have also been noted as being sold as medical treatments, of which scientific evidence does not support and may present significant health risks to an individual’s health.
In addition to issuing warning letters, requiring money to be refunded to consumers, seizures of operations, and federal court injunctions, efforts have been employed to halt fraudulent, unapproved products from being imported through United States borders.
The FDA has expressed that these unapproved products not only violate federal law but pose a significant health risk to the public. Specifically, the FDA is concerned that consumers may waver, postpone, or avoid appropriate medical care as a result of these products’ false claims. Therefore, the FDA has maintained an aggressive surveillance program to identify and enforce action upon fraudulent product claims.
Of the COVID-19-related warning letters currently issued, about 72% of the firms or companies warned are now in a corrective status. The FDA, along with the Federal Trade Commission (FTC), request with the warning letters that the firms or companies respond in a 48-hour timeframe to outline the specific actions implement to correct violations.
The FDA and FTC’s surveillance program includes:
- Continuous follow-up with companies who do not implement adequate corrections.
- Monitoring of social media platforms and online marketplaces to ensure products are not sold on an alternative website or under a different name.
- Monitoring of incoming complaints to FDA’s Health Fraud Program or the Office of Criminal Investigations.
- Monitoring of adverse events or quality problems reported by consumers or health care professionals, which are related to COVID-19 products, to the FDA’s MedWatch program.
- Collaboration with major retailers, in which the task force has requested assistance in monitoring online marketplaces for products claiming to prevent, mitigate, treat, diagnose, or cure COVID-19.
In addition to the warning letters issued for fraudulent products, the FTC has issued warning letters for service providers and communication companies assisting and facilitating illegal scam telemarketing phone calls related to COVID-19, which target consumers’ fears of the global pandemic and result in the spreading of misinformation.
The FDA and FTC plan to continue collaborating to protect consumers from the deceptive scams and significant health risks imposed by fraudulent products with unsubstantiated claims to prevent and treat COVID-19.
Within the FDA policy document for COVID-19-related diagnostic tests, the FDA acknowledges that that “circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of the novel coronavirus”. However, such detection diagnostics and tests must first be validated before use, followed by notification to the FDA and the option to submit an Emergency Use Authorization request. As of April 29th, 2020, the FDA had issued 50 individual EAUs for COVID-19 tests and the FDA had been notified that over 235 laboratories had begun testing. In addition, the FDA had worked with more than 380 test developers who have plans to submit EAU requests for COVID-19 tests.
What questions do you have about unapproved products and Emergency Use Authorization requests amid the COVID-19 pandemic? Contact us to learn more about how we can help.Sheffield's Women of Steel - COVID-19: We can beat this via photopin (license)