All Things Bunnies, Inc. – FDA Warning Letter, May 16, 2024

The FDA issued a Warning Letter to Michelle Jorgenson concerning the marketing of Toltrazuril 5% Suspension on allthingsbunnies.com. From December 2023 to May 2024, the FDA reviewed the website and determined the product is an unapproved new animal drug under sections 201(g)(1) and 201(v) of the FD&C Act.

Violations include marketing Toltrazuril 5% Suspension for the treatment and prevention of coccidiosis in animals, with claims such as "most effective, non-invasive treatment," "kills coccidia," and "safer and more effective than Albon." These claims establish the product's intended use as a drug. The product is considered a new animal drug because it is not generally recognized as safe and effective by experts.

Since Toltrazuril 5% Suspension lacks an approved new animal drug application, conditional approval, or index listing under sections 512, 571, and 572 of the FD&C Act, it is deemed unsafe under section 512(a) and adulterated under section 501(a)(5). Introducing or delivering this product into interstate commerce is prohibited under section 301(a).

The FDA requires a written response within fifteen working days detailing specific corrective actions, steps to prevent recurrence, and supporting documentation. Failure