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Law360 (March 12, 2021, 9:27 PM EST) -- The number of fraudsters that emerged during the pandemic spurred a federal government initiative called Operation Quack Hack, and now a year later, a Law360 analysis of the crackdown found surprises in what turned out to be the biggest COVID-19 product scams.
The U.S. Food and Drug Administration's list of fraudulent products included the exaggerated claims of dietary supplements, vitamins and herbs, but what stood out were the more strange and esoteric goods promoted as coronavirus cure-alls and prophylactics — including substances that can be found in the backyard.
And a century-old nostrum reemerged in the 21st century as an early pandemic treatment. The problem is, this one comes with an unusual side-effect: It turns skin blue.
Last but not least, experts observed that the FDA, often criticized for its slow pace, acted with alacrity to the crisis, swiftly issuing warning letters to suspected scammers and demanding fast responses while addressing the pandemic on other fronts.
Here's what Law360 found after reviewing about 170 warning letters posted by the FDA since early March 2020, some in conjunction with the Federal Trade Commission.
Top COVID-19 Product Scams
Well-known dietary supplements and vitamins, including zinc and vitamin D, were common targets of the FDA's warning letters, which wasn't surprising to experts.
The natural products industry is geared toward being proactive with one's health, said Venable LLP's FDA group co-chair Claudia Lewis, who represents dietary supplement companies. So it makes sense that products promoting immune support would be popular with consumers right now.
"And it's not surprising to me the FDA is doubling its effort to monitor the market to make sure the claims are appropriate," Lewis said.
Under the FDA regulations for dietary supplements, companies are limited in what kinds of claims they can make, such as that a product supports one's health or promotes bone structure, for example. While a company can claim its supplement helps the immune system, any mention of COVID-19 is going to quickly draw the FDA's attention, attorneys said.
Most companies in the dietary supplement industry are already aware that they can't make disease-specific claims, said Greenberg Traurig LLP shareholder Justin Prochnow, adding that he suspects that most recipients of the warning letters were new to the scene. To suddenly make COVID-19 claims raises a red flag in the industry, he said.
"So that's why it makes me think that it's companies that don't traditionally make those types of claims and for whatever reasons, all of a sudden decided it would be a good idea to do it now during COVID," Prochnow said.
One of the letters singled out chaga mushrooms, which Prochnow pointed to as an example of the wide range of scams on regulators' radar.
Other eyebrow-raising products included a cure-all called "BEEhive Delight," a handful of stem-cell-derived treatments. Even the invasive kudzu vine and common weeds like dandelion and chickweed were sources of COVID-19 frauds.
And while not exactly a dietary supplement, several companies got tagged for making the odd assertion that inhaling salt particles could ward off the coronavirus.
An Old Gimmick Made a Pandemic Comeback
Colloidal silver was the product at the center of the first high-profile warnings over the coronavirus. Just five days before the World Health Organization declared the outbreak a pandemic, the FDA fired off a warning letter to televangelist Jim Bakker for advertising silver coronavirus products.
A little over a month later, the FDA and the FTC ordered the far-right conspiracy theorist Alex Jones and his online InfoWars store to stop peddling toothpaste containing silver as a cure-all for COVID-19.
In the past year, at least a dozen other companies have received warning letters about touting colloidal silver as a panacea for COVID-19. A suspension of silver particles in liquid, colloidal silver was initially used in the early 20th century, but its use fell off after more modern medicine was developed, according to Memorial Sloan Kettering Cancer Center.
Among the FDA's safety concerns about colloidal silver is that its ingestion can turn the user's skin blue. The irreversible condition is called argyria and it is caused by the pigmentation that occurs when silver particles in the skin are exposed to the sun.
"Surprisingly, you don't have to take that much for you to turn blue," said Lewis, who recalled encountering colloidal silver claims when she first started practicing FDA law in the early 1990s.
"It's always been viewed as something that would treat a rare disease or help fight off bacteria and other microorganisms in the body," Lewis said. "So it wasn't surprising to me that it had sort of a resurgence."
FDA Shows Its Proactive Side
The FDA tends to be more reactive in normal times, Prochnow said, pointing out that the agency usually gives companies 15 business days to respond to warning letters. But in the recent letters over coronavirus claims, the FDA asked recipients to respond in 48 hours, he said.
"So that to me is one of the biggest differences. They're taking aggressive action to get this information off of websites as soon as possible," Prochnow said.
In addition to demanding speedy responses, the FDA joined forces with the FTC on numerous occasions to smack down COVID-19 hucksters. The agencies' most recent letters went to a company that boasted the coronavirus-prevention properties of its antiviral wipes and another promising that a mouth spray containing CBD and "nano silver" could fight off the illness.
These coordinated actions indicate that federal regulators are open to using all the tools at their disposal to tackle fraudsters during the ongoing crisis.
"This seems to be a strategic action to ensure that the government has as many options as possible available to it when a recipient fails to respond to the warning letter or otherwise take corrective action, and the government needs to take enforcement to the next level," Joanne Hawana of Mintz Levin Cohn Ferris Glovsky and Popeo PC told Law360.
Specific types of products have also been singled out in batches of warning letters, such as one recent burst that targeted temperature devices. This suggests the FDA may be looking at COVID-19 claims by product type as part of its approach to tracking down pandemic frauds, said Prochnow of Greenberg Traurig.
"They'll go through different sectors and say, OK, we're going to search COVID and we'll look at this today, and then COVID in this group of products, and go through different sets of products all the time," Prochnow said.
And of course, the FDA is focusing on cracking down on flagrant COVID-19 claims at the same time as it is carrying out its usual regulatory activities, while also responding to the pandemic by studying and approving vaccines and taking a look at some of the requirements for personal protective equipment and other products needed to respond to the global emergency.
In a way, the pandemic has given the FDA an opportunity to reevaluate some of its systems so it can provide some flexibility for companies to enter the marketplace in times of crisis, Venable's Lewis said.
"It's also an opportunity for those who are opportunists to take advantage of the marketplace," Lewis said. "So I feel like a lot of these warning letters are really showing that the FDA is giving flexibility, but also making sure that truthful and safe information is being communicated."
--Editing by Breda Lund and Jill Coffey.
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