CPSC Issues COVID-19 Consumer Products Guidance, Further Muddying the Regulatory Waters and Increasing Scrutiny of COVID-19 Products
As the COVID-19 pandemic continues, and with an incoming Biden administration that is expected to step up efforts to control the spread of the virus, use of personal protective equipment (“PPE”) and cleaning/disinfectant products has never been more important or widespread among the public. However, in late October, the Consumer Product Safety Commission (“CPSC”) issued guidance on its website asserting that certain consumer protection rules within its jurisdiction apply to PPE, and reminding consumers of the CPSC laws that apply to cleaning/disinfectant products (the “COVID Guidance”).
The CPSC commissioners disagree about the import or official applicability of the COVID Guidance, and questions abound as to how it interplays with FDA regulations issued by the U.S. Food and Drug Administration (“FDA”), including Emergency Use Authorizations (“EUA”), as well as EPA regulations on disinfectant products – not to mention how or whether the COVID Guidance impacts the protections afforded by the Public Readiness and Emergency Preparedness Act (the “PREP Act”). But in any case, the guidance unquestionably heightens scrutiny around COVID-related products, and likely will give consumer plaintiffs’ attorneys additional lawsuit fodder – so manufacturers should understand it.
Broadly, the COVID Guidance covers two broad categories of products: face coverings, gowns, gloves (i.e., PPE), and cleaning/disinfectant products.
Face Coverings, Gowns, and Gloves
Under the COVID Guidance, face coverings, gowns, and gloves designed for consumer use are considered “articles of wearing apparel” and therefore must (1) comply with the flammability requirements of the Flammable Fabrics Act; and (2) be tested to either 16 C.F.R. Part 1610 (Standard for the Flammability of Clothing Textiles) or Part 1611 (Standard for the Flammability of Vinyl Plastic Film), depending on the materials used for construction. Further, U.S. manufacturers and importers of these products must issue a General Certificate of Conformity (“GCC”) certifying that these clothing articles meet all applicable requirements.
The COVID Guidance imposes additional requirements for PPE apparel designed specifically for children’s use (i.e., ages 12 and under). Under the Consumer Product Safety Act (“CPSA”), all children’s products must bear permanent tracking information, meet total lead content limits, and meet lead in paint or similar surface coating limits (if either a paint or surface coating is present on the product). Product testing must take place at a CPSC-accepted testing lab, and U.S. manufacturers/importers of these products must also issue a Children’s Product Certificate.
Household cleaning solutions – for example, hand sanitizers and soaps – are primarily regulated by the FDA, but also fall under the jurisdiction of the CPSC if they constitute a “hazardous substance” under the Federal Hazardous Substances Act (“FHSA”). Generally, the FHSA defines a “hazardous substance” as (1) a substance (or mixture of substances) that may cause substantial personal injury or substantial illness during customary or reasonably foreseeable handling or use, including reasonably foreseeable ingestion by children; and (2) the substance (or mixture of substances) is toxic, corrosive, an irritant, a strong sensitizer, is flammable or combustible, or generates pressure through decomposition, heat, or other means. The FHSA requires that hazardous substances bear prominent warnings on their labels – for example, “KEEP OUT OF REACH OF CHILDREN,” “DANGER”, and “HARMFUL OR FATAL IF SWALLOWED,” among others.