Chewy, Inc. Warning Letter Details

Summary

Chewy, Inc. was cited for distributing unapproved veterinary drugs intended for aquarium fish and birds, including antibiotic products such as Aqua-Mox, Aqua-Ceph, Aqua-Cipro Forte, and others, without FDA approval or proper drug listing. The products violated the Federal Food, Drug, and Cosmetic Act because they were misbranded—neither drug listed with FDA nor manufactured in FDA-registered facilities—and their website claims established they were intended to treat, cure, or prevent disease, thereby classifying them as new animal drugs requiring approval. The products violated section 301(a) of the FD&C Act by introducing unapproved and misbranded new animal drugs into interstate commerce.