Lagging Indicators?

Beyond the Curve: Dr. Peter Lurie's COVID-19 Blog

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Well before there was a U.S. COVID-19 epidemic, we had a non-fatal epidemic that spread almost unchecked – an epidemic of misinformation propagated by dietary supplement makers foisting their misbranded products upon unsuspecting consumers. Years before SARS-CoV-2 stalked the land, CSPI’s market scans found supplements fraudulently marketed as treatments for opioid addictiontobacco addiction, and infertility.

When the pandemic hit, we knew, based on our prior work on supplements and other scams, that the profiteers would not be far behind. Unfortunately, crisis provides ample breeding grounds for deliberate attempts to make money from misinformation and public confusion. The Food and Drug Administration (FDA) put it bluntly: “Unfortunately, during outbreak situations, fraudulent products claiming to prevent, treat or cure a disease almost always appear.”1

To combat these inevitable scams, FDA launched “Operation Quack Hack” in March 2020 and, within a few months, identified more than 700 fraudulent and unproven medical products related to COVID-19.2 A year later, the agency had issued over 170 warning letters to sellers, more than 297 reports to online marketplaces, and more than 288 abuse complaints to domain registrars.3

Recently, a publication called Law360 reviewed the 170 COVID-19–related warning letters and found that about half involved dietary supplements (the number one target), cannabidiol (CBD), and colloidal silver products (see chart below).4 The range of offending products is striking and includes such ex-Presidential favorites as hydroxychloroquine as well as hand sanitizers and, more recently, temperature detection devices.


It’s often said that hospitalizations and deaths from COVID-19 are “lagging indicators” in that they tend to follow COVID-19 cases by a few weeks. Tongue planted firmly in cheek, we suggest with some license that we just might have discovered a new lagging indicator. FDA warning letters on supplements and other products appear to follow COVID-19 deaths by a couple of months, as indicated by the figure below, in which we superimpose the US epidemic curve on Law360’s FDA warning letter curve.

Law360's \

FDA’s enforcement action against osteopath Joseph Mercola is a prime example of its efforts to address COVID-19 claims. After CSPI reported Mercola’s misleading claims, FDA issued a warning letter stating that three of his dietary supplements were being marketed illegally with claims to mitigate, prevent, treat, diagnose, or cure COVID-19 and urged him to cease such promotions.5 

Unfortunately, Mercola is only one example among hundreds of purveyors of supplements and other products preying on people’s coronavirus fears. During the course of the pandemic, CSPI has flagged several fraudulent COVID-19 claims—including claims by Mercola, Jim Bakker, and the “MyPillow Guy”—and testified before a senate subcommittee on the prevalence of such scams.

Although marketed for COVID-19, many of these cure-all products existed well before the pandemic, obtained a new lease on life during the pandemic, and will doubtless continue to exist well after life returns to “normal.” For example, before colloidal silver was touted for COVID-19,6 it was for decades promoted as a cure for a cornucopia of diseases.7 And the Federal Trade Commission (FTC) has also previously pursued enforcement actions against supplements with unsubstantiated claims related to the opioid epidemicthe nation’s high rates of obesity, and H1N1 influenza.

In other words, these COVID-19 scams are symptoms of wider failures in the dietary supplement marketplace. Bad actors continue to exist in large part because FDA’s Office of Dietary Supplement Programs lacks the regulatory authority needed to keep the market free of unsafe and/or ineffective products. And its resources are a pittance compared to an over-$40 billion industry marketing an estimated 80,000 dietary supplements.8 Heck, FDA doesn’t even know which products are being sold. How can the agency effectively police a marketplace under those conditions?

As a result, COVID-19 has become yet another way station in a long line of opportunities for profiteers to market false hopes and cure-alls. Unless we cure the regulatory failures in the dietary supplement marketplace, these practices will thrive long after the COVID-19 pandemic and Operation Quack Hack are laid to rest. Because, when the next pandemic rears its ugly head, you can be sure these same products will turn out, by some stroke of luck, to be “effective” against the new scourge as well.

This post was written in collaboration with CSPI regulatory counsel Jensen Jose.


References

  1. FDA. Ebola Preparedness and Response Updates from FDA. January 23, 2020. https://www.fda.gov/emergency-preparedness-and-response/mcm-issues/ebola-preparedness-and-response-updates-fda. Accessed August 27, 2020.
  2. Food and Drug Administration (FDA). FDA Protects Patients and Consumers from Fraud During COVID-19. July 20, 2020. https://www.fda.gov/news-events/fda-voices/fda-protects-patients-and-consumers-fraud-during-covid-19. Accessed March 29, 2021.
  3. FDA. FDA COVID-19 Response: At-A-Glance Summary. March 26, 2021. https://www.fda.gov/media/137005/download. Accessed April 2, 2021.
  4. Law360. Charting A Year Of The Biggest COVID Scams Cited By FDA. March 12, 2021. https://www.law360.com/foodbeverage/articles/1363821/charting-a-year-of-the-biggest-covid-scams-cited-by-fda. Accessed March 29, 2021.
  5. Food and Drug Administration (FDA). WARNING LETTER. Mercola.com, LLC: MARCS-CMS 607133. February 18, 2021. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/mercolacom-llc-607133-02182021. Accessed March 29, 2021.
  6. E.g., US Food and Drug Administration (FDA). WARNING LETTER: SilveryGuy MARCS-CMS 609843. August 14 2020. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/silveryguy-609843-08142020. Accessed August 27, 2020; E.g., Center for Science in the Public Interest (CSPI). CSPI Urges FDA Enforcement Action on Televangelist Jim Bakker’s Fake Coronavirus “Cure”. February 20, 2020. https://cspinet.org/news/cspi-urges-fda-enforcement-action-televangelist-jim-bakkers-fake-coronavirus-cure-20200218. Last Accessed August 27, 2020.
  7. 64 Fed. Reg. 44653 (August 17, 1999) (In 1999, FDA stated, “FDA is issuing this final rule because many OTC drug products containing colloidal silver ingredients or silver salts are being marketed for numerous serious disease conditions and FDA is not aware of any substantial scientific evidence that supports the use of OTC colloidal silver ingredients or silver salts for these disease conditions.”).
  8. FDA. Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight. February 11, 2019. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-new-efforts-strengthen-regulation-dietary. Accessed April 2, 2021.
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