Last week, press reported that the U.S. Food and Drug Administration (FDA) would assess distilleries making hand sanitizer $14,060 in fees as Monograph Drug Facilities (MDF) under the Over-the-Counter (OTC) Monograph Drug user fee program for fiscal year (FY) 2021. Several days later, on December 31, 2020, the Department of Health and Human Services (HHS) Office of Public Affairs tweeted a statement from Brian Harrison, HHS Chief of Staff. According to the...
Archives
November 2, 2020
EPA Announces the Issuance of an Advisory on UV Lights That Claim to Kill or Be Effective against Viruses and Bacteria
On October 30, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a Compliance Advisory on ultraviolet (UV) lights claiming to kill or be effective against viruses and bacteria. EPA states that the Advisory was issued to provide an explanation to the UV light industry that UV lights are regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) as pesticide devices...
On October 26, 2020, the U.S. Environmental Protection Agency (EPA) announced that it is soliciting public comment on the interim guidance on registering products that claim to have “residual” or “long-lasting” effectiveness against viruses. This announcement follows up on EPA’s October 14, 2020, announcement that it would begin expediting its review of products with residual efficacy intended for use against SARS-CoV-2, the coronavirus that causes...
October 21, 2020
EPA’s Draft Residual Efficacy Protocols for “Long-Lasting” Efficacy for Antiviral Products
On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released a much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19. EPA’s guidance specifies scientific testing requirements for two different types of products: (1) disinfectants that also provide residual efficacy, and (2)...
October 14, 2020
EPA Announces Expedited Pathway for Companies to Claim “Long-Lasting” Efficacy for Antiviral Products
On October 14, 2020, the U.S. Environmental Protection Agency (EPA) released much-anticipated draft guidance that will allow companies to demonstrate that their products have “long-lasting” or “residual” effectiveness on surfaces against viruses like SARS-CoV-2, the coronavirus that causes COVID-19. As most know, EPA has not before now provided guidance on how stakeholders can demonstrate to EPA’s satisfaction that their product remains efficacious for periods of time,...
August 26, 2020
EPA Announces Approval of First-Ever Long-Lasting Antiviral Product for Use against COVID-19
On August 24, 2020, the U.S. Environmental Protection Agency (EPA) announced the issuance of a Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 18 emergency exemption to the state of Texas permitting it to allow American Airlines and Total Orthopedics Sports & Spine to use a new product that is believed to inactivate coronaviruses like the SARS-CoV-2 virus on surfaces for up to seven days. EPA states that after carefully reviewing the available data and...
August 6, 2020
EPA Issues SSURO against EcoShield LLC for Selling an Unregistered Product Claiming Effectiveness against SARS-CoV-2
On August 5, 2020, the U.S. Environmental Protection Agency (EPA) issued a Stop Sale, Use or Removal Order (SSURO) against EcoShield LLC (EcoShield) for selling a clip-on badge product called the Eco AirDoctor Portable that claims to sanitize the air of pathogens. EPA states that the product was being sold and distributed in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) because it is an unregistered pesticide making false disinfectant claims. ...
On July 30, 2020, the U.S. Environmental Protection Agency (EPA) announced it approved amended labels for 13 products based on laboratory testing that shows the products are effective against SARS-CoV-2, the virus that causes COVID-19. These products, and two previously announced products (see our July 7, 2020, blog), are the only products for which EPA has reviewed laboratory testing data and approved label claims specifically against SARS-CoV-2. In January 2020, at the...
On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced the release of new guidance (Guidance) for registrants of products on or eligible for inclusion on List N, EPA’s list of disinfectant products that EPA has concluded meet EPA’s criteria for use against SARS-CoV-2, the virus that causes COVID-19. This new guidance provides expedited procedures for those registrants that wish to add electrostatic application methods to their disinfectant product...
July 9, 2020
EPA Announces Research Studying the Potential Long-Lasting Effectiveness of Disinfectants against SARS-CoV-2
On July 7, 2020, the U.S. Environmental Protection Agency (EPA) announced that EPA researchers are evaluating a number of commercially available products for potential long-lasting effectiveness against SARS-CoV-2, the novel human coronavirus that causes COVID-19. This research is being conducted at EPA’s Office of Research and Development’s Center for Environmental Solutions and Emergency Response in Research Triangle Park, North Carolina, using surfaces that mimic the...