A year on from the coronavirus pandemic, it’s harder than ever to know which products to trust. The pandemic has left medical and wellness markets filled with misleading claims, rash solutions, and downright scammers crouching for fake and inadequate products.
The FDA is working to separate the wheat from the chaff, granting emergency clearances to well-researched and tested treatments, and working with other agencies and companies to shut down bad actors trying to break into the market.
FDA against modern “snake oil sellers”
In a recent post by FDA Voices, Judy McMeekin, Associate Commissioner for Regulatory Affairs, PharmD, outlined the agency’s ongoing battle against Covid-19 scammers selling supposed medicines and vaccines. The FDA has found more than 1,300 fraudulent products and issued hundreds of warning letters since last year. seized web domains and responded to requests to close some online stores. Targets range from counterfeit drugs and vaccine injections to sketchy herbal teas purported to prevent Covid-19.
According to Dr. McMeekin poses a twofold risk with double Covid cures. Untested, unidentified substances can be dangerous in and of themselves, but especially during the pandemic, they can also create a false sense of security. That feeling, in turn, can lead to riskier decisions and possible exposure to the virus.
With the pandemic also affecting the country’s mental health, the FDA is facing a second front in its battle. The agency has taken action against traders who claim to be selling nutritional supplements and other so-called cures for serious illnesses like depression.
The FDA does not test supplements for effectiveness, but does regulate labeling, for example. Dietary supplements are regulated as food, so dietary supplement manufacturers are not required to provide evidence of their claims. They are also not tested for drug interactions, and that can cause problems if you are taking other medications. The FDA states that “Products used to cure, treat, alleviate, or prevent disease are pharmaceuticals and are subject to the requirements that apply to pharmaceuticals, even if labeled as dietary supplements.”
The agency summed up the situation with one simple rule: “If claims sound too good to be true, they probably are.” FDA-approved treatments are sold direct through healthcare professionals, and none are currently for sale online available.
Not that clean sweep
In addition to the spread of hand disinfectants from various manufacturers, there is also a new technical aspect: There are disinfection products and devices for the private, commercial and medical sectors that also require precise testing
You have likely noticed tools for sale at drug stores and department stores that claim to disinfect with ultraviolet light. Some look like magic wands while others are the size of common devices like cell phones.
These devices seem like real business, but the reality isn’t that promising. PC Magazine consulted several experts, all of whom doubted that devices marketed to the general public would be effective. A Discover Magazine report found that many consumer devices simply aren’t powerful enough or don’t use the right wavelengths to actually kill germs. FDA guidelines indicate that consumer devices may not be able to provide the high dose of UV light and long exposure times required to effectively kill Covid-19.
The PPE problem
At the beginning of the pandemic, decontamination was very important in the healthcare sector – not only for facilities and patient rooms, but also for personal protective equipment. Shortages caused hospitals to take drastic measures to preserve their limited supplies.
A new industry quickly emerged to adapt masks for repeated use. Peter Tsai, the inventor of the N95 mask, came out of retirement to help the N95DECON project develop methods to disinfect and reuse the masks. Disposable N95 masks can now be stretched for days or even weeks – a practice the CDC has endorsed through official guidelines on the reuse of respirators.
Decontamination options were described in an ECRI webcast in April 2020. At this point in time, 48% of the hospitals surveyed were already using at least one method to disinfect masks for further use. Hydrogen peroxide and UV light were the two main options. One of the first methods to be approved for emergency use, a hydrogen peroxide-based system from the Battelle Memorial Institute, saw widespread use in the spring of 2020. The company later received a warning letter that side effects were not being adequately followed up. The company did not respond to our request for comment.
Despite the stabilization of production, hospitals are still rationing to ensure an even supply of masks and to keep costs down. However, researchers and frontline workers are concerned about supplies, as well as current CDC guidelines and hospital guidelines on who needs high-level protective equipment. They argue that ventilation and respiratory protection guidelines have not been updated enough to resolve airborne contagion, especially for non-healthcare workers and hospital staff who have no direct contact with Covid patients.
To add insult to injury, users must now ask if the PPE available can be trusted to protect them.
Following the FDA’s rare EUA umbrella allowing the use of foreign masks such as China’s KN95, the newly expanded market quickly filled with rings of foreign and domestic counterfeiters. Imitations and other inadequate masks look real, but often don’t offer the same level of protection.
Healthcare Safety Guardian, ECRI, found that up to 70% of the KN95 masks tested did not meet the minimum safety standards for healthcare use. Some imported masks came along with fake National Institute for Safety and Health at Work (NIOSH) approval papers, fake registration numbers, and information copied from other products.
Several large-scale scams for selling masks have also been exposed. Homeland Security Secretary Alejandro N. Mayorkas told reporters that the agency had confiscated over 11 million counterfeit N95 masks in the past few weeks, including 1 million in a single raid in Maryland.
Many of these problematic PPE mimick real, FDA-approved models from well-known manufacturers. In addition to Maryland, investigators also seized masks in Washington state and Minnesota. All in all, the numbers were in the millions. Healthcare providers should consult guides like these from the FDA to identify legitimate manufacturers, and those from the CDC to filter out the counterfeit masks.
Steve Francis, director of the Department of Homeland Security’s Intellectual Property Coordinating Center, described the counterfeits as “extremely dangerous” and added, “They provide a false sense of security for our first responders and American consumers.” It is important that frontline workers receive legitimate N95 masks.
Counterfeit and ineffective shipments weren’t just limited to masks or PPE. Covid testing was also a big target as many high profile cases were uncovered during the course of 2020. Fake Covid tests were particularly common in the UK. Some of this British supply even made its way to the US coast, although aggressive customs and border patrol controls kept some from reaching the market.
The fight goes on
With President Biden suggesting that vaccine supplies may not stabilize until May and return to normal life a year later, a real end to the pandemic remains unreachable. And that means we have to view any product with a healthy level of skepticism and do the necessary homework to make sure it is trustworthy before we buy it.
Sean Marsala is a Philadelphia, Pennsylvania-based health journalist. With a passion for technology, he can usually read, surf the Internet, and explore virtual worlds.