Products That Tout Antimicrobial Claims May Fall Under Federal Regulations
During the current COVID-19 pandemic, there are a growing number of products in the promotional products marketplace that include, or are advertised as including, pesticide or antimicrobial additives that may or are expected to kill or deter microorganisms, including viruses. Cory Halliburton, PPAI’s general counsel, provides this important alert regarding the regulation of these products.
Suppliers and distributors of promotional products should be aware that products containing a pesticide, as well as the advertising and labeling of such products, are regulated by the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and that, with a few exceptions, those products must be registered through the Environmental Protection Agency (EPA).
FIFRA enforcement is focused on the sale, distribution and use of pesticides. Generally, a pesticide is defined as any substance (or mixture of substances) intended for a pesticidal purpose, which includes being used for the purpose of preventing, destroying, repelling or mitigating any “pest.” See 40 C.F.R. § 152.3. Under FIFRA, “pest” is defined as an organism that, under circumstances, makes it “deleterious to man or the environment,” including certain viruses. See 7 U.S.C. 136(t) and 40 C.F.R. § 152.5(d).
The EPA regulates and is currently scrutinizing what it believes are false or misleading advertising claims and labeling relating to products that may contain pesticide substances, and that are advertised or labeled as being effective in some manner against COVID-19. According to a recent announcement from the EPA, it ordered Amazon Services, LLC and eBay, Inc. to stop selling a wide range of pesticide products, including products that were labeled or marketed with false or misleading claims of efficacy against the cause of COVID-19. According to the EPA, the products in issue were unregistered, misbranded or restricted-use pesticides, and pesticide devices that make false or misleading claims. See “EPA Orders Amazon and eBay to Stop Sale of Certain Pesticide Products,” EPA press release issued June 11, 2020. The EPA noted labeling or advertising statements that the EPA believed were not compliant with legal requirements, including phrases such as “Kills COVID-19,” “Coronavirus disinfectant” and “Efficient disinfection to prevent the spread of disease.”
Those who sell or distribute products in violation of FIFRA may be subject to civil fines and even criminal punishment pursuant to the authority vested in the EPA by 7 U.S.C. § 136l. In 2018, the EPA increased the maximum fine for each violation of FIFRA’s registration requirements to $19,446. See 83 Fed. Reg. 1190 (Jan. 20, 2018). Violations committed “knowingly” are subject to a fine not to exceed $50,000 or imprisonment for up to one year, or both. See 7 U.S.C. § 136l(b). FIFRA violations involving the distribution or sale of a product may be assessed by the number of transfers or shipments, and the scope of distributions or sales may date back as much as five years from the date of the civil administrative complaint. The amount of fines depends, in part, on when the violation occurred and when penalties are assessed. When assessing penalties and punishment for violations of FIFRA, the EPA utilizes various enforcement response policies and guidance, including the EPA’s 2009 FIFRA Enforcement Response Policy.
PPAI has long been an advocate of product safety and compliance throughout the supply chain. The recent increase in products unique to the “pest” known as COVID-19 has triggered another sleeping regulatory giant in FIFRA and the EPA. Those in the promotional products industry who are engaged in the manufacture, sale, shipment or distribution of products governed by FIFRA and regulated by the EPA are wise to carefully evaluate the registration requirements as well as any labeling or advertising associated with those products.
Additional Information Resources:
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- Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Federal Facilities
- Summary of the Federal Insecticide, Fungicide, and Rodenticide Act
- EPA’s FIFRA Questions and Answers
- EPA, Consumer Products Treated with Pesticides.
- Memo from Marcia Mulkey, EPA, to Persons Responsible for Registration of Pesticide Products, March 6, 2000
- National Pesticide Information Retrieval System, Search Federal Pesticide Products
- 7 U.S.C. § 136l
- Civil Monetary Penalty Inflation Adjustment Rule, 83 Fed. Reg. 1190, 1193 (Jan. 10, 2018)