By Lisa M. Campbell, Lisa R. Burchi and Kelly N. Garson
On June 11, 2020, the U.S. Environmental Protection Agency (EPA) announced in a press release that it issued stop sale, use, or removal orders (SSURO) to Amazon.com Services LLC (Amazon) and eBay, Inc. (eBay) for selling certain pesticide products that EPA claims are unregistered, misbranded, or restricted-use pesticides, and pesticide devices that EPA asserts make false or misleading claims. The SSUROs address over 30 products sold on Amazon and over 40 products sold on eBay, and include several products marketed with what EPA believes are false or misleading claims of efficacy against the novel coronavirus, SARS-CoV-2, the cause of COVID-19.
EPA notes that Amazon and eBay are two of the largest e-commerce marketplaces and that they oversee millions of product listings. EPA further notes that it has held discussions with the companies, and other e-marketplaces, to stop sales of products that falsely claim to be effective against COVID-19, as discussed on our blog. Prior SSUROs issued to Amazon are discussed on our blog.
Registration of pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) is required prior to selling or distributing pesticides in the United States and it is a violation of FIFRA Section 12(a)(1)(A) to sell or distribute an unregistered pesticide. The EPA-approved label for a FIFRA registered pesticide product contains directions for use, precautionary statements, and other provisions that reflect EPA’s evaluation of data to and determination of acceptable risk for the product at issue when used as directed on the label. Pesticide products and devices are considered “misbranded” and in violation of FIFRA if, among other potential facts, they contain false or misleading claims and/or if their labels are missing certain required information (e.g., ingredients, precautionary statements, and directions for use).
EPA included a list of the products and devices at issue in attachments to the SSUROs. In the Amazon SSURO, EPA states that none of the listed products is registered with EPA, and that the products were misbranded because EPA believes they contain one or more false or misleading statements on their labels. In the eBay SSURO, EPA provides three attachments listing products eBay offered for sale that EPA claims are unregistered, misbranded, or classified as restricted use in violation of FIFRA.
The SSUROs prohibit Amazon and eBay from distributing, selling, or offering these products for sale. EPA requires that Amazon submit a written accounting of all the violative products listed in the attachment to the SSURO, including providing the location, quantity, and container size for these products, every 30 days for the next 150 days following Amazon’s receipt of the SSURO, or until Amazon no longer has the violative products in its ownership, custody, or control. Amazon must obtain written approval from EPA before it moves or removes any of the products from its facilities. EPA requires eBay to notify EPA of the corrective actions eBay will take regarding the violative products in writing within ten days of receiving the SSURO.
EPA notes in its press release the following examples of what it believes are pesticidal claims made for the products at issue that would require their registration prior to sale or distribution:
- “Kills COVID-19”
- “Complete sterilization including the current pandemic virus”
- “Coronavirus disinfectant”
- “2020 Coronavirus Protection Coronavirus Protection Clearance Sale”
- “A Powerful, Green, Non-Toxic Solution Proven to Inactivate our current viral strain”
- “Epidemic Prevention”
- “Efficient disinfection to prevent the spread of disease”
- “Help keep your family and those you care for healthy”
- “Nontoxic causes no permanent injuries”
- “Ingredients are biodegradable and have no harmful impact on the environment”
- “There is no damage to the environment”
- “You can easily purify the living environment”
- “Safe for all people using”
- “Gentle to Child & Pets”
- “Chemical Free”
EPA claims as additional violations that the products it believes are pesticide devices sold by Amazon also lack required EPA establishment numbers (i.e., site-specific information for the facility where the pesticide or device was produced) that is a required element on all pesticide and device labels.
The eBay SSURO also addresses claims that eBay sold restricted-use pesticides without limiting those sales to certified applicators as required by FIFRA Section 12(a)(2)(F). EPA states that EPA representatives purchased and received restricted-use products listed in Attachment C, Table 2 of the SSURO, but were not certified applicators at the time of the purchase, and were not required to submit proof that they were certified applicators prior to or during the sale. Restricted-use pesticides may only be distributed or sold to certified applicators or persons under their direct supervision. Certified applicators and persons they directly supervise are the only persons authorized to use restricted-use pesticides.
EPA’s press release highlights the following products:
- Described as a “particularly egregious” case are products found on Amazon containing Chlorine Dioxide sold with “unprovable claims of sanitizing and disinfecting hospitals, offices, and homes.” In addition, several versions of the product listed on the site have very little to no English-language instructions.
- Product listings on eBay.com include 55-gallon drums of Methylene Chloride marketed for use against SARS-CoV-2 as a disinfectant and paint stripper. Methylene Chloride is not approved for use against SARS-CoV-2. EPA notes also that EPA banned the retail sale of Methylene Chloride to consumers for paint removal purposes under the Toxic Substances Control Act “due to acute fatalities that resulted from exposure to the chemical.”
- Product listed on eBay called Virus Shut Out claiming to be a spatial disinfection card that would provide protection against SARS-CoV-2 to the wearer. Virus Shut Out was subject to previous EPA enforcement action, discussed in our earlier blog items.
- Product listed on eBay called Xtreme-Bio stating that it was exempt from EPA regulation and made entirely with “clean, green, safe, environmentally friendly ingredients” and that made claims to deactivate SARS-CoV-2.
EPA has been vigilant in reviewing and acting quickly to address products making claims against coronavirus, SARS-CoV-2, and COVID-19. The actions against Amazon and eBay are significant, as other actions have been largely targeted toward producers. The responses to the SSUROs will be of interest and should be monitored.
Additional information on EPA’s efforts to discover and protect against fraudulent products is available on our blog.
By Lisa M. Campbell, Heather F. Collins, M.S., and Barbara A. Christianson
On June 1, 2020, the U.S. Environmental Protection Agency’s (EPA) Office of Enforcement and Compliance Assurance (OECA) announced that it issued a compliance advisory on products claiming to kill SARS-CoV-2, the novel coronavirus that causes COVID-19.
EPA states that the advisory was issued because it has received tips and complaints concerning potentially false or misleading claims, including efficacy claims, associated with pesticides and devices. EPA says it is actively reviewing these claims and is working to identify others. EPA states that it intends to pursue enforcement for those products making false and misleading claims regarding SARS-CoV-2. EPA has made available a webpage where tips can be reported.
The advisory reiterates EPA’s message that disinfectant products that claim to kill viruses must be registered with EPA before they can be sold and that pesticide products cannot legally make claims that they kill a particular pathogen, such as SARS-CoV-2, unless EPA has authorized the claim during the registration process.
In the advisory, EPA emphasizes that it will not register a product claiming to be effective against SARS-CoV-2 until it has determined that the product will not pose an unreasonable risk and will be effective when used according to the label directions. EPA notes that it maintains List N, which is a list of disinfectants that meet EPA’s criteria for use against the virus that causes COVID-19. While surface disinfectant products on List N have not been tested specifically against SARS-CoV-2, EPA expects them to kill the virus because they demonstrate efficacy against a harder-to-kill virus or another human coronavirus similar to the one causing COVID-19.
The advisory also discusses devices that claim to kill SARS-CoV-2. It states that a pesticidal device is an instrument or other machine that is used to destroy, repel, trap, or mitigate any pests, including viruses (i.e., ozone generators, UV lights). EPA notes that unlike registered pesticide products, the safety and efficacy of pesticidal devices are not routinely reviewed by EPA. EPA states that it therefore cannot confirm whether, or under what circumstances, such products might be effective against SARS-CoV-2. The advisory states that consumers should be aware that pesticidal devices making such claims have not been reviewed and accepted by EPA. It further states that while pesticidal device labels must have an EPA establishment number (which identifies where a product was produced), they will not have an EPA registration number because pesticidal devices are not subject to the same registration requirements as pesticides.
According to the advisory, pesticidal devices are subject to certain regulatory requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), one of which is a prohibition of false or misleading labeling claims. The advisory specifically states:
Making false or misleading labeling claims about the safety or efficacy of a pesticidal device may result in penalties under FIFRA. Please note that ozone generators, UV lights and other pesticide devices may not be able to make claims against coronavirus where devices have not been tested for efficacy or safety for use against the virus causing COVID-19 or harder-to-kill viruses. In addition, because EPA does not review these data as part of a registration review process, these claims are not supported by any government review.
Because EPA does not review or register pesticide devices, these products are not included on List N.
It is important for pesticide device producers to review carefully the data supporting the claims made for their devices to ensure that they comply with the regulatory requirements under FIFRA.
By Lisa R. Burchi and Barbara A. Christianson
On March 10, 2020, the Federal Trade Commission (FTC) and U.S. Food and Drug Administration (FDA) announced that warning letters were sent to seven companies for allegedly selling unapproved products that may violate federal law by making deceptive or scientifically unsupported claims about their ability to treat coronavirus (COVID-19). The warning letters are the first issued by the Agencies alleging unapproved and/or unsupported claims that products can treat or prevent COVID-19/coronavirus.
The agencies sent the letters to the following companies:
- Vital Silver;
- Quinessence Aromatherapy Ltd.;
- GuruNanda, LLC;
- Vivify Holistic Clinic;
- Herbal Amy LLC; and
- The Jim Bakker Show.
Each of the seven companies have advertised products as able to treat or prevent COVID-19/coronavirus. The unapproved products include teas, essential oils, and colloidal silver.
According to FDA, there are no approved vaccines, drugs, or investigational products currently available to treat or prevent the virus. FDA Commissioner Stephen M. Hahn, M.D. stated: “The FDA considers the sale and promotion of fraudulent COVID-19 products to be a threat to the public health. We have an aggressive surveillance program that routinely monitors online sources for health fraud products, especially during a significant public health issue such as this one. The FDA’s laws are designed to protect the public health by ensuring, among other things, that drugs are safe and effective for their intended uses.”
The letters state that one or more of the efficacy claims made by the marketers are unsubstantiated and therefore may violate the FTC Act. The letters advise the recipients to cease immediately making all claims that their products can treat or cure coronavirus.
FTC Chair Joe Simons stated: “There already is a high level of anxiety over the potential spread of coronavirus. What we don’t need in this situation are companies preying on consumers by promoting products with fraudulent prevention and treatment claims. These warning letters are just the first step. We’re prepared to take enforcement actions against companies that continue to market this type of scam.”
FTC and FDA have pledged to continue to monitor social media, online marketplaces, and incoming complaints to ensure these products do not continue to make such claims. The letters sent emphasize that, if the false claims do not cease, FTC may seek a federal court injunction and an order requiring money to be refunded to consumers and instructing the recipients to notify the FTC within 48 hours of the specific actions they have taken to address FTC’s concerns.
In addition, the FTC recently issued a new consumer blog post with information about how to identify and avoid coronavirus-related scams. Coronavirus: Scammers follow the headlines notes that scammers are creating websites to sell bogus products, and using fake emails, texts, and social media posts as a ruse to take consumers’ money and obtain personal information. It then warns consumers of the “red flags” to monitor when shopping for products related to the virus.
EPA also has been active in this area, announcing the release of a new list of EPA-registered disinfectant products that have qualified for use against SARS-CoV-2, the coronavirus that causes COVID-19 and also announcing its process for expediting review of submissions made by companies that are requesting to add Emerging Viral Pathogen claims to its labels of already-registered surface disinfectants.
By Lisa R. Burchi and Kelly N. Garson
EPA recently released the Consent Agreement and Final Order (CAFO) for the October 31, 2019, settlement discussed in our blog post “EPA Settles Two Cases Regarding Unregistered and Misbranded Pesticides.” This October 31, 2019, settlement between U.S. Environmental Protection Agency (EPA) Region 3 and AFCO C&S, LLC (AFCO), a chemical company located in Chambersburg, Pennsylvania, to resolve alleged violations of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Pursuant to the CAFO, AFCO agreed to pay a $1,489,000 penalty to settle the alleged violations that involved the use of 12 products to clean and sanitize food and beverage processing facilities.
The CAFO provides more information on the violations Region 3 alleged. The CAFO allegations state that AFCO sold and distributed 10unregistered pesticide products on at least 1,031 separate occasions in violation of FIFRA Section 12(a)(1)(A). The CAFO also alleges that AFCO sold and distributed a product that made claims beyond those permitted by its FIFRA registration on at least five separate occasions. It additionally alleges that AFCO sold or distributed a misbranded pesticide on 41 separate occasions.
EPA initially collected the information during an inspection of AFCO’s establishment in Chambersburg, Pennsylvania on June 20, 2016. The settlement also addresses violations of a Stop Sale, Use or Removal Order (SSURO) that EPA issued to AFCO on July 13, 2018, requiring AFCO to immediately cease all sales and distributions of the 12 products. The CAFO alleges that AFCO engaged in sales and distributions that violated this order, having sold or distributed the products from at least January 1, 2015, through either August 8 or August 9, 2019. AFCO has since discontinued sales of all of the involved products, except for one registered product, for which EPA issued an Order Modification letter on March 4, 2019, allowing AFCO to recommence sales.
AFCO will pay the civil penalty within one year in 12 equal monthly installments, plus interest payment of $7,954.96, totaling $1,496,954.96.
By Lisa R. Burchi and Kelly N. Garson
The U.S. Environmental Protection Agency (EPA) recently settled two cases involving allegations of non-compliance with the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Although the Consent Agreement and Final Orders (CAFO) and Stop Sale, Use or Removal Orders (SSURO) issued in these cases are not yet available online, the penalty amounts at issue -- $200,000 and $1,489,000 -- reflect increased enforcement in targeted areas and EPA’s willingness to seek and obtain heroic penalties.
On November 18, 2019, EPA Region 9 announced that Decon7 Systems LLC (Decon7) would pay a $200,000 civil penalty in a settlement related to FIFRA violations. Specifically, EPA found that Decon 7:
- Sold and distributed two products that were not registered with EPA. These products, “D7 Part 1” and “D7 Part 2,” combined to disinfect hard nonporous surfaces. EPA regulations (40 C.F.R. § 152.15) set forth the conditions under which EPA will consider a product to be a pesticide product required to be registered, including but not limited to products containing certain “active” ingredients and/or making claims to kill, repel, or “disinfect” certain pests (e.g., germs, bacteria, viruses).
- Sold and distributed pesticides that were labeled with false and misleading claims regarding safety and efficacy. In addition to misleading efficacy claims to kill all bacteria, viruses, and fungi, EPA states:
The products also had false and misleading safety claims, which created the incorrect impression that the products were noncorrosive and nontoxic. The products’ formulations in fact could have caused skin burns and irreversible eye damage. The products’ labeling also claimed the products were used by various federal government agencies to clean up buildings following anthrax attacks, implying that the federal government recommends or endorses their use.
- Exported unregistered pesticides that did not include necessary notifications and failed to comply with reporting obligations following a SSURO issued to the company in 2018.
On October 31, 2019, EPA Region 3 announced that it reached an agreement with AFCO C&S, LLC (AFCO), a chemical company located in Chambersburg, Pennsylvania, to resolve alleged FIFRA violations. AFCO agreed to pay a $1,489,000 penalty to settle the alleged violations that involved the use of 12 products to clean and sanitize food and beverage processing facilities. EPA alleges that AFCO sold and distributed ten unregistered pesticide products, a misbranded product, and a product that made claims beyond those permitted by its FIFRA registration.
The settlement also addresses violations of a SSURO that EPA issued to AFCO on July 13, 2018. AFCO engaged in sales and distributions that violated this order. AFCO has since discontinued sales of all of the involved products, except for one registered product.