On Monday, March 30, 2020 the U.S. Department of Health and Human Services (DHHS) issued a notice in the Federal Register declaring certain goods as “scarce,” which means it is illegal to hoard those items. The DHHS is acting under authority granted by President Trump under the Defense Production Act of 1950 (the “Act”).
By declaring certain goods as scarce, the accumulation of those goods (1) in excess of the reasonable demands of business, personal, or home consumption, or (2) for the purpose of resale at prices in excess of prevailing market prices is prohibited. Any person or business who willfully fails to comply is subject to fines up to $10,000 and/or up to one year imprisonment. This is a federal crime that may be investigated by federal law enforcement agencies and prosecuted by the United States Attorneys in each federal district.
The 15 categories identified by the DHHS are:
- N–95 Filtering Facepiece Respirators;
- Other Filtering Facepiece Respirators (e.g., those designated as N99, N100, R95, R99, R100, or P95, P99, P100);
- Elastomeric, air-purifying respirators and appropriate particulate filters/ cartridges;
- Powered Air Purifying Respirators (PAPRs);
- Portable Ventilators, including portable devices intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas;
- Drug products with active ingredient chloroquine phosphate or hydroxychloroquine HCl;
- Sterilization services for any device as defined in section 201(h) of the Federal Food, Drug, and Cosmetic Act and sterilizers as defined in 21 CFR 880.6860, 880.6870, and 880.6880;
- Disinfecting devices and products intended to kill pathogens and other kinds of microorganisms by chemical means or physical means;
- Medical gowns or apparel, e.g., surgical gowns or isolation gowns;
- Personal protective equipment (PPE) coveralls, e.g., Tyvek Suits;
- PPE face masks, including any masks that cover the user’s nose and mouth and may or may not meet fluid barrier or filtration efficiency levels;
- PPE surgical masks, including masks that covers the user’s nose and mouth and provides a physical barrier to fluids and particulate materials
- PPE face shields, including those defined at 21 CFR 878.4040 and those intended for the same purpose;
- PPE gloves or surgical gloves, including those defined at 21 C.F.R. § 880.6250 (exam gloves) and § 878.4460 (surgical gloves) and such gloves intended for the same purposes;
- Ventilators, anesthesia gas machines modified for use as ventilators, and positive pressure breathing devices modified for use as ventilators (collectively referred to as ‘‘ventilators’’), ventilator tubing connectors, and ventilator accessories as those terms are described in FDA’s March 2020 Enforcement Policy for Ventilators and Accessories and Other Respiratory Devices During the Coronavirus Disease 2019 (COVID–19) Public Health Emergency located here.
The DHHS Notice is available here.
For more information, contact Kean Miller attorneys: Lauren Rucinski (Environmental Regulatory), Maureen Harbourt (Environmental Regulatory), Jennifer Jones Thomas (Health Law) and Scott Huffstetler (Labor and Employment Law, OHSA).
 The Defense Production Act is found at 50 U.S.C. § 4501 et seq. via Executive Order 13910 (https://www.whitehouse.gov/presidential-actions/executive-order-preventing-hoarding-health-medical-resources-respond-spread-covid-19/), President Trump delegated authority to the Secretary of DHHS to designate materials as scarce under section 102 of the Defense Production Act of 1950, 50 U.S.C. § 4502.
 50 U.S.C. § 4512.
 50 U.S.C. § 4513.
 Includes devices that are disposable half-face-piece nonpowered air-purifying particulate respirators intended for use to cover the nose and mouth of the wearer to help reduce wearer exposure to pathogenic biological airborne particulates.
 Includes single-use, disposable half-mask respiratory protective devices that cover the user’s airway (nose and mouth) and offer protection from particulate materials at an N95 filtration efficiency level per 42 C.F.R. § 84.181.
 Includes devices that already have FDA marketing authorization and those that do not have FDA marketing authorization but are intended for the same uses.
 Includes those defined in 21 C.F.R. § 876.1500, § 880.6992, and § 892.1570. and other sanitizing and disinfecting products suitable for use in a clinical setting.