FDA WARNING_LETTER - Chewy, Inc. - November 30, 2023

The FDA issued a Warning Letter to Sumit Singh of Chewy.com on November 30, 2023, concerning the distribution of unapproved and misbranded veterinary products for aquarium fish and birds. An FDA review of Chewy.com in November 2023 identified products such as Aqua-Mox, Aqua-Ceph, and Aqua-Cipro Forte, marketed with claims indicating their use for disease treatment in animals, thus classifying them as drugs under the FD&C Act.

These products are deemed "new animal drugs" intended for minor species (nonfood-producing fish and birds) but lack the required FDA approval, conditional approval, or index listing, rendering them unsafe and adulterated. Furthermore, they are misbranded because they are not drug listed with the FDA, nor were they manufactured in an FDA-registered facility, violating sections 510(b) and (j) and 502(o) of the FD&C Act. The introduction of these unapproved and misbranded drugs into interstate commerce violates section 301(a) of the FD&C Act.

The FDA expressed particular concern as these over-the-counter products contain medically important antimicrobials, raising public health concerns regarding antimicrobial resistance. The letter advises Chewy.com to obtain index listing, approval, or conditional approval for these products and to ensure proper establishment registration and drug listing. The firm must respond within fifteen working days,