EPA issues guidance on absence-of-ingredient label claims for pesticides

Background: FIFRA and labeling

• Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), EPA is tasked with regulating the sale and use of pesticides within the U.S. Before a pesticide can be marketed in the U.S., it must be registered with the EPA. Registration involves reviewing scientific and effects data on the pesticide. All pesticide products must be properly labeled with information on how to apply and handle the products safely and effectively. These pesticide labels are required to contain specific information on the pesticide, including contact information, hazard statements, use classifications, directions, and more.
• EPA does not just regulate what may be present on a pesticide label, it also regulates the absence of information in those labels, or any claims that note the absence of an ingredient. During registration, EPA evaluates whether the labeling is misbranded, where “its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is false or misleading in any particular.” This includes statements that are false or misleading comparisons with other pesticides or devices, true statements used in a misleading way, certain safety claims, or comparative statements on the safety of the product.
• The agency first began providing guidance on the absence of ingredient claims in the early 2000s in the Label Review Manual. The agency most recently updated the chapter on labeling in November 2013, where it noted that statements or claims that express the absence of certain ingredients may be misleading statements under pesticide guidance. The agency also released guidance on absence of ingredient claims in 2021, stating that “free of [active ingredient]” claims and similar ones may constitute misbranding, as some users may understand these statements to be safety claims.

Guidance on claims

• On February 1, 2024, EPA announced a new guidance on absence of ingredient claims. The EPA focused the guidance on FIFRA-regulated products (including both pesticides and FIFRA-covered devices but noted that the regulation was mostly relevant to pesticide products). The guidance represents the EPA’s current approach to “absence of an ingredient” claims for labels.
• The agency’s main concern with absence of ingredient claims is that these claims could give pesticide users the impression that products without a certain ingredient are safer or pose less of a risk than products that contain the ingredient. EPA considers these types of claims misleading, as it states that it holds all products to the same FIFRA registration standards. However, the agency noted that there are certain situations where absence of ingredient claims may not be considered false or misleading by the agency. If these claims are narrowly stated for purposes other than conveying information on the safety of the product, the agency noted that the possibility to mislead users is “limited.”
• One of the major areas that the EPA noted may be acceptable for absence of ingredients are claims regarding sodium hypochlorite (bleach). The agency explained that certain consumers may want bleach, or not want bleach, based on its specific capabilities. The agency believes that the absence of bleach claims are generally not false or misleading, specifically when “used to help consumers make informed choices about purchasing antimicrobial surface sanitizer, surface disinfectant, and laundry sanitizer products.”
• However, EPA qualified this advice by stating that it views absence of bleach claims differently when pesticide products contain chlorinated chemistries. These products contain a mechanism that breaks the chlorinated substances down into free chlorine, which performs the pesticidal activity. The agency therefore believes that absence of bleach claims for these types of products would generally be false or misleading. EPA also views absence of bleach claims differently for products that are not antimicrobial surface sanitizers, surface disinfectants, or laundry sanitizers even if those products do not contain bleach or bleaching agents. EPA notes that although these claims may be true, many of these products would never have bleach or bleaching agents in the first place, making the addition misleading.
• The agency also found issue with claims related to the absence of phosphates, which can be added to cleaning products that are not regulated under FIFRA as well as antimicrobial laundry sanitizers that are regulated by FIFRA. Generally, the purpose for both products is to reduce soap scum. In general, EPA will not consider “absence of phosphates” claims, even when used without a qualifying statement, for claims on antimicrobial laundry sanitizer products (that do not contain phosphates as an inert ingredient).
• Unlike phosphate claims, EPA stated that claims related to the absence of N,N-Diethyl-meta-toluamide (DEET) (CAS RN 134-62-3) were more likely to run afoul of EPA regulations. The agency explained that negative public perceptions of DEET may be misleading for EPA-registered insect repellents applied to human skin or clothes, unless those claims have a qualifying statement. The agency noted that it would not consider an “absence of DEET” claim necessarily misleading if it was accompanied by a statement such as “*not a safety claim.” The agency also recommended the use of longer qualifying statements, including “the phrase “DEET free” should not be viewed as a statement on the safety of this product relative to any product containing DEET.”

Guidance on the application process

• EPA also released a table within the guidance to explain the actions that product registrants or applicants can take to have the EPA approve absence of ingredient claims. The agency plans to review these claims on a case-by-case basis and requests that any registrant or applicant who submits a request explain how the absence claim is narrowly tailored to not mislead users about the safety of the product.

Next steps

• Although the agency is overall skeptical of absence of ingredient claims, the agency clearly recognizes that some are not misleading. The guidance should provide additional flexibility to registrants who may wish to add the claims onto pesticide labels, however the flip side of the coin is the time that the EPA will likely take to actually approve the label amendments. If the agency takes a significant amount of time to review a minor label amendment, the actual impact of the changes in labels could be diminished.

To contact the author of this analysis, please email Walker Livingston.

To contact the editor of this analysis, please email Patricia Iscaro.

Key Documents and Dates

• Guidance on “Absence of an Ingredient” Claims Associated with Federal Insecticide, Fungicide, and Rodenticide Act-Regulated Products (February 1, 2024)
• EPA pesticide labels site