The continued spread of COVID-19 and the imposition of increasingly strict guidelines on the general public by governments around the world in an effort to limit infection rates have, unfortunately, also created an environment where bad – or opportunistic – actors can take advantage of widespread anxiety to market products that tout diagnostic or treatment effects against the virus. Of note, the U.S. Food and Drug Administration (FDA) has stressed that, to-date, no diagnostic test, drug, or preventative therapy for COVID-19 has been cleared or approved for use via FDA’s traditional premarket pathways, and that existing investigational products have not yet been fully tested for safety or effectiveness. Yet entities and individuals have – largely via the Internet and social media – quickly begun to promote new or existing products for mitigation of the virus’s impacts (e.g., by detecting it more accurately or in a broader population, or by reducing the symptoms).
On 6 March 2020 FDA – in conjunction with the Federal Trade Commission (FTC), with which it shares jurisdiction over advertising of medical products – issued Warning Letters to seven entities making such inappropriate claims about teas, essential oils, tinctures, and colloidal silver. Most of the cited entities were manufacturers; but in a rarer display of its authority, FDA also flexed its muscles against a daily TV broadcast – the Jim Bakker Show – for making claims on its website and offering for sale a silver solution that could allegedly kill the new coronavirus. The Warning Letters indicated that because these products were intended to mitigate, prevent, treat, cure, or diagnose COVID-19 in people, they constituted unapproved new drugs being sold in violation of the Federal Food, Drug, and Cosmetic Act. Furthermore, because there is not currently any product available to prevent, treat, or cure COVID-19, the letters indicated that these entities were advertising products without competent and reliable scientific evidence substantiating that the claims were true when made, in violation of the Federal Trade Commission Act.
Reflecting the urgency of the present situation, these Warning Letters gave recipients only 48 hours to respond – to both federal agencies – describing the specific steps they would take to correct the violations, as compared to the 15 days typically granted for responding to an FDA Warning Letter. FDA has also released a dedicated webpage to inform the public about fraudulent COVID-19 products. This webpage includes links to both the 6 March Warning Letters and a Flickr photo album containing photos of the misbranded products, where available, to facilitate recognition by consumers. The Agency has stated that once a cited violation has been corrected, the corresponding entry will be updated accordingly.
On the heels of these Warning Letters, FDA published another press release on 20 March 2020 stating that it is aggressively monitoring the marketing of unauthorized diagnostic test kits being sold for users to test for COVID-19 in their homes. The statement emphasized that there is presently no COVID-19 test with FDA authorization for home use, though the Agency is open to that possibility in the future if safety and accuracy can be assured. It also noted that FDA expects to issue additional Warning Letters in this space as more violative entities are discovered, and that enforcement has been stepped up at ports of entry to ensure that fraudulent products originating from outside the U.S. do not enter the country. The press release encouraged those aware of fraudulent – i.e., unauthorized – test kits for COVID-19 to report them to FDA at FDA-COVID-19-Fraudulent-Products@fda.hhs.gov.
FDA also issued a Consumer Update this past Tuesday (24 March) urging the public to beware of fraudulent tests, vaccines, and treatments for COVID-19. The notice reminds the public that no vaccines, drugs, or home-use tests have yet been authorized for use by FDA, and urges caution in identifying false or misleading claims. It emphasizes that given the current status, the products consumers see on the market may be dangerous not only by likely failing to do what they claim, but further by potentially causing adverse effects, interfering with essential medications, and/or delaying proper treatment. In particular, FDA warned of the use of chloroquine phosphate, which is sold to treat parasites in aquarium fish but has been used – in some cases causing death – by consumers who believed it could protect them based on reports of ongoing studies of the drug chloroquine’s potential efficacy against COVID-19. The Agency encouraged consumers and health care professionals to report suspected fraud in this space to the FDA’s Health Fraud Program or Office of Criminal Investigations.
FDA has a fair amount of discretion in choosing when and how to enforce the rules governing medical product marketing and promotion, but – as it has done before in situations accompanied by heightened susceptibility of vulnerable consumers – it will not take fraudulent claims about the novel coronavirus lightly. The Agency is particularly concerned that products claiming to cure, treat, or prevent COVID-19 may cause consumers to delay or stop appropriate medical treatment, which could lead to serious or life-threatening harm. FDA is also particularly sensitive about the potential for consumers to be misled about this virus given the widespread alarm caused by the daily-evolving nature of the pandemic and the associated uncertainty about the best steps to mitigate infection rates.
As we have indicated in other publications, FDA has loosened many of the regulatory paradigms that govern U.S. marketing authorizations for COVID-19-related drugs and medical devices in an effort to make needed products available more quickly. The Agency has been actively working with laboratories and industry towards the issuance of Emergency Use Authorizations (EUAs) for diagnostic tests to detect the presence of the virus, and has thus far authorized several laboratory-performed tests and one point-of-care test. FDA is also working with other government bodies and academic centers to examine whether certain drugs, including chloroquine (already approved for other uses) and antivirals, could potentially be effective against COVID-19. However, the Agency simultaneously remains the public health watchdog. In that critical role, FDA will continue to balance the risks and benefits of all medical products proposed for marketing in the United States. As recent FDA announcements have emphasized, though what constitutes an acceptable balance between risks and benefits has shifted somewhat in the face of the current emergency, that determination remains the Agency’s to make.
We will continue to monitor this evolving issue and provide updates as they become available.
Authored by Heidi Gertner, Kelliann Payne, Suzanne Levy Friedman, Arthur Kim