An AP investigation has uncovered numerous sales of counterfeit masks, which have cost providers millions of dollars and put lives at risk, as opposed to approved masks like the ones above.

Counterfeit masks costing providers millions, putting lives at risk

May 18, 2020
by John R. Fischer, Senior Reporter
A rise in counterfeit masks, gloves, gowns and other supplies throughout the COVID-19 pandemic has cost providers across the U.S. millions and is putting lives at risk.

More than 500 seizures and 11 arrests have been made by Immigration and Customs Enforcement’s Homeland Security Investigations (HSI) in what the Associated Press reports is being called Operation Stolen Promise, for not just masks and PPE but mislabeled medicines and fake COVID-19 tests and cures.

“It’s just unprecedented,” Steve Francis, assistant director for global trade investigations at HSI, told AP. “These are really bad times for people who are out there trying to do the right thing and be helpful, and they end up being exploited.”

The issue caught AP’s attention after a Los Angeles shipment of masks in late March were found to be fake. Whereas authentic ones have bands stitched, soldered or stapled into the mask that stretch across the back of the head for a tighter fit, the ones delivered had ear loops and glued on straps. Such masks allow tiny airborne droplets carrying the virus to get sucked through cracks, thereby spreading the disease.

“Fluid follows the path of least resistance: If someone is breathing and the respirator doesn’t have a good fit, it will just go around,” infectious disease expert Shawn Gibbs, the dean of Texas A&M University’s school of public health, told AP.

The masks were produced at a Chinese factory called Shanghai Dasheng and bore a stamp that made them look as though approved by the U.S. National Institute for Occupational Safety and Health (NIOSH). The U.S. Centers for Disease Control and Prevention, however, issued an alert the day before, that any N95 masks with ear loops from Shanghai Dasheng were counterfeit.

One organization to receive these masks was Direct Relief, an international humanitarian aid organization in Southern California. Initially thinking the factory sent the wrong mask model, CEO Thomas Tighe alerted the federal government of the issue after reading the CDC’s warning.

“It’s a little scary that it had gone through what we understood was an aggressive customs investigation for export, and an aggressive customs import by the U.S., and still got through,” CEO Thomas Tighe told AP. “It’s been a real lesson.”

The CDC is currently discussing authenticity issues with Shanghai Dasheng, which is one of a small number of Chinese companies certified to make NIOSH-approved U.S. medical grade N95s. The factory has bumped daily mask production from 40,000 to 70,000 and intends to eventually manufacture them at a rate of 200,000. “We don’t have any distributors, dealers or branch factories. Beware of counterfeit,” the company posted on its website.

The warning, however, has not been enough to stop the entire sale of counterfeit masks at the same price as authentic ones, which have been gouged from 60 cents a mask before the pandemic to $6 a piece now, according to AP. The rise in counterfeit masks stems from a government decision in March to allow providers to use other unapproved medical masks with ear loops in order to offset the shortage of N95 masks. It partially reversed its stance this month after finding many models to be substandard and banned imports from 65 Chinese factories. Shanghai Dasheng is one of 14 that remain approved.

The relaxation of these standards costs state and local governments and hospitals hundreds of millions spent on flawed items. AP tracked other shipments of Shanghai Dasheng ear loop N95 masks as they arrived at U.S. hospitals and healthcare organizations through shipping labels and invoices, certified letters and interviews with buyers, distributors and middlemen.

One buyer was pediatric physician assistant Tyler Alvare of Alexandria, Virginia who, upon learning of the issue with the Shanghai Dasheng ear loop masks, immediately notified everyone he gave one to. He blames the government for placing the responsibility of obtaining enough protective equipment on healthcare systems, rather than taking on the task itself. “It’s really outside of our area of expertise.”

To help prevent further counterfeit sales, the CDC has issued a set of pointers for distinguishing authentic from fake respirators.

Signs that a respirator may be counterfeit:
No markings at all on the filtering face piece respirator
No approval (TC) number on filtering face piece respirator or headband
No NIOSH markings
NIOSH spelled incorrectly
Presence of decorative fabric or other decorative add-ons (e.g., sequins)
Claims of approval for children (NIOSH does not approve any type of respiratory protection for children)
Filtering face piece respirator has ear loops instead of headbands