Key Takeaways

• On February 1, 2024, EPA released new guidance clarifying how the Agency would evaluate “absence of an ingredient” claims on pesticide product labels going forward.
• In a departure from longstanding EPA policy, the Agency may now accept “DEET-free,” “bleach-free,” and “phosphate-free” claims under specified circumstances.
• EPA explains how pesticide product registrants can comply with the new guidance and submit label amendment applications.

Background

Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the U.S. Environmental Protection Agency (EPA or the Agency) must approve all pesticide product label language through the registration process. Among other requirements, product labels cannot include any “false or misleading statements” as set forth under EPA’s regulations.

According to longstanding policy, EPA has considered “absence of an ingredient” statements on pesticide product labels to be presumptively misleading. Even if true, EPA has considered these claims unacceptable because they may “falsely suggest” that a product is less risky, better, or more desirable than another product that contains the ingredient in question.

Over the years, EPA frequently cited this policy when disapproving the proposed use of statements such as “DEET-free” on pesticide product labels. In practice, however, EPA label reviewers also occasionally approved the same claims for some products. For example, at times, EPA approved certain products using the active ingredients picaridin or oil of lemon or eucalyptus with “DEET-free” claims, even as EPA would routinely reject identical “DEET-free” claims for other products with the same or similar compositions.

New Guidance

On February 1, 2024, EPA issued new guidance on “absence of an ingredient” claims for pesticide products. According to EPA, this guidance is intended to clarify the status of “absence of an ingredient” claims on FIFRA-regulated product labels.

The guidance reinforces EPA’s decades-old position that “absence of an ingredient” claims are inappropriate when they “could give users the impression that products without a certain ingredient are safe or safer, less risky, better, or more desirable than products containing that ingredient.” But EPA newly acknowledges that “absence of an ingredient” claims may also be used in ways that limit potential confusion to consumers in some circumstances. According to EPA’s new guidelines, a proposed “absence of an ingredient” claim will be approved if EPA determines that the claim is not false or misleading because (1) it is used for purposes other than conveying information about product safety for humans or the environment, and (2) it is supported by data demonstrating that the claim would not be misleading to users or appropriately qualified to limit the potential to mislead users.

EPA also provides guidance concerning the acceptability of three specific claims commonly proposed by pesticide registrants: “absence of bleach,” “absence of phosphates,” and “absence of DEET.” According to EPA, “bleach-free” and “phosphate-free” claims will generally be accepted in connection with many types of FIFRA-registered products. EPA states that it will also generally accept “DEET-free” claims if followed by an asterisk and qualified by a prominently displayed statement such as “*Not a safety claim.”

In addition, EPA’s guidance explains how applicants and registrants can modify existing applications or registrations consistent with its new guidelines.

Conclusion

In accordance with its new guidance, EPA states that it will begin reviewing proposed “absence of an ingredient” claims on pesticide product labeling on a case-by-case basis. If consistently applied going forward, EPA’s policy may help establish a more uniform approach for pesticide registrants seeking to make such label claims in connection with their products.

Beveridge & Diamond’s Pesticides practice has worked for forty years with U.S. and international clients who research, develop, obtain government approvals for, manufacture, promote, and use pesticidal products and devices. We represent large and small companies with an emphasis on entities that invest in research to discover, develop, and defend new technology. Our Pesticides practice helps clients identify business objectives and implement the most effective regulatory, commercial, litigation, and legislative strategies to achieve or exceed those objectives.