Growing Mask Popularity
Wearing masks to reduce the chance of contracting or transmitting infection is nothing new. Asian countries have been wearing them for years. For different reasons, Muslim women have worn burkas. What people in the United States and other countries are adjusting to is the requirement for everyone to wear masks when out of doors. While some individuals fashion homemade solutions, others shop for something more reliable. This has fueled unprecedented demand.
Hospital demand for N95 and surgical masks has increased by orders of magnitude. The United States production is pumping out 50 million masks per month. It is estimated there is a need for 300 million monthly. California Governor Newsom has local and overseas contracts to receive 200 million disposable surgical and N95 masks per month.
Garment industries and technology companies are repurposing production lines to ship every type of face mask imaginable. Retailers are clearing shelves of ski masks, cycling masks, dust masks, diving and snorkeling goggles in the name of personal protective equipment (PPE). Solutions range from decorative to effective.
Well-built masks advertise layers of filtration while ineffective ones highlight breathability. People with weak respiratory systems and children may benefit from the “breathable” variety. Online marketplaces have been delisting products marketed as anti-viral without supportive documentation. Dust particles are much larger than aerosolized viruses.
“If you are amassing critical medical equipment for the purpose of selling it at exorbitant prices, you can expect a knock at your door,” said Attorney General William Barr. “The Department of Justice’s COVID-19 Hoarding and Price Gouging Task Force is working tirelessly around the clock with all our law enforcement partners to ensure that bad actors cannot illicitly profit from the COVID-19 pandemic.”
Import and Export PPE Restrictions
Since February 29, 2020, the FDA has issued 23 guidance memoranda for industry and/or FDA staff about the alteration of enforcement or regulatory requirements in light of the COVID-19 crisis. On March 28 the FDA issued new rules on respirators/masks that can be used “in healthcare settings by HCP when used in accordance with CDC recommendations to prevent wearer exposure.…”
On April 1, China issued new rules on who can export PPE and medical testing products from China. Under this Order, any Chinese exporter of listed medical devices must meet two requirements. First, the device must be registered in China through a Medical Device Product Registration Certificate. Second, the exporter must prove that the device complies with the regulations of the importing country as they apply to that device.
The laws are designed to hinder price gouging and prevent substandard medical testing products, masks, face shields, and respirators used in medical settings. Masks for the general population are essentially garments. However, the plethora of newly issued guidelines is causing customs officials to err on the side of caution and reject shipments.
Importers must comply with CBP and FDA regulations
Failure to properly import FDA-regulated medical devices could result in detention or seizure of the shipment (see 21 C.F.R. § 800.55), civil penalties of up to $15,000 per violation, or even criminal prosecution. See 21 U.S.C. § 333. These are in addition to penalties that CBP may impose, under 19 U.S.C. § 1592, for violations of relevant CBP statutes and regulations on the entry of goods, which could be as high as the domestic value of the imported merchandise for fraudulent behavior, and in addition to delays in clearing the goods through U.S. customs.
Even with checks and balances, supply and demand fuel a rollercoaster of soaring medical PPE prices and shortages. Some international shipments of surgical and N95 masks are being confiscated and diverted to healthcare workers. Wholesalers are having their entire inventory bought by large retailers. Shipments fortunate enough to get through customs may be scooped up by shoppers within a few days if not hours.
Seems Like An Abundance
The expression mask shortage might sound perplexing to consumers who are out and about. Make-shift shops and hucksters are swarming the streets and lining roadways near shopping centers. Several online marketplaces have become overrun with mask options. All these options differ from medical-grade. They may lack proper protection for the general population.
Price comparison is complicated by the fact that many customers who purchase products online prefer the cost to include shipping. Retailers may list products at different price points with and without free shipping. Unit cost must also absorb shipments that do not make it through.
By now, masks worn in public are as common as shoe laces. Nearly everyone has them. But many masks do not ft properly, may not provide adequate filtration, have too much filtration, or are worn out. ClinicalPosters sells mask optimized for the public in both adult and child sizes.
- How Gov. Newsom Secured 200 Million Masks Per Month For California Amid Worldwide Shortage. forbes.com
- New cost details emerge in California’s secretive coronavirus masks deal with Chinese company. latimes.com
- Police send N95 masks confiscated from price gougers to coronavirus front lines. cnet.com
- Delaware medical supplier says FEMA seized 400,000 N95 masks; now he's out millions of dollars. usatoday.com
- US works to assure allies, deny allegations of seizing supplies in 'mask wars'. abcnews.go.com
- Buying Face Masks and Other PPE from China Just Got a LOT Tougher. chinalawblog.com
- Importing face masks and personal protective equipment during COVID-19? thompsoncoburn.com