Environmental Protection Agency (EPA) Completes Review of Seresto Collar and Confirms Continued Registration; Data Affirms Safety Profile of the Product

Elanco Animal Health Incorporated (NYSE: ELAN) and the U. S. Environmental Protection Agency (EPA) today announced that EPA, with support from the Food and Drug Administration (FDA), has completed its comprehensive, multi-year review of the Seresto flea and tick collar. EPA confirms continued registration of the collar. Comprehensive data affirms the safety profile of Seresto.

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As part of EPA’s scientific review process, the agency analyzed incident data including third-party assessments and compared data to other EPA-registered pet products. EPA’s conclusions found that the most frequently reported incidents were primarily dermatologic in nature, such as itching or redness around the collar site, which is consistent with previous findings. According to EPA, Seresto continues to meet all of EPA’s standards for registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), which ensures that products do not pose unreasonable risk of harm.

Following the comprehensive review, Elanco and EPA developed a stewardship program that Elanco will implement as a leader in the collar category. The program includes:

• Enhanced data collection for adverse event (AE) reports
• Continued annual enhanced reporting of Seresto AE data, similar to what EPA requires for pet spot-on products
• Outreach to the veterinary community
• Review of the collar release mechanism
• Separation of product registrations for dog and cat
• Updates to package insert language
• Five-year registration review to ensure stewardship program actions support the continued safe use of Seresto. Elanco will complete a renewal process near the end of this period.

Elanco encourages EPA to implement these measures as a new EPA standard across all flea and tick collars to ensure consistent expectations for reporting across the category, similar to the elevated standards the agency implemented in 2010 for pet spot-on pesticide products (products applied directly to the skin of pets for flea and tick control).